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Starting immediately, Arcoma will be selling Arcoma branded systems integrated with Canon image software and detectors throughout Europe, the Middle East and Africa.

Until now, Canon distributors have bought the image software and the detectors directly from Canon Europe, having two points of sourcing for a complete system. This new agreement allows Arcoma to deliver the completely integrated system, ensuring functionality, quality and reducing installation time for its customers. The agreement will increase Arcoma sales by approx. 25 MSEK per year and will strengthen the Arcoma brand in Europe considerably.

“We are proud to be able to sell the complete Arcoma branded systems with the Canon detectors throughout EMEA. The strengthened alliance with Canon allows us to pre-stage systems prior to installation, thus reducing installation time for end-users and ensuring system functionality and quality. This is further an important part of Arcoma’s strategy to strengthen the Arcoma brand and increase its product offering”, says CEO Mikael Högberg.

Life Science Ventures Fund II portfolio Company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that preclinical data with its oral T-cell immunotherapy platform, including one preclinical development candidate, VXM10, are being presented at the upcoming “AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications” being held October 26-30, 2017 in Philadelphia, PA, USA. The poster will be presented during Poster Session B in session category “Tumor Immunology Targets” on Sunday October 29, 12:30 PM – 4:00 PM in Hall E.

Sunstone Life Science Fund II portfolion Company CMC Contrast AB acquires Oncoral Pharma Aps to further strengthen its product portfolio within oncology. In connection with the acquisition, the company is re-named to Ascelia Pharma AB.

“Through the acquisition, Ascelia Pharma is truly established as a pioneer in developing novel medicinal products to address unmet medical needs for people living with cancer. The acquisition of Oncoral broadens our oncology product portfolio and fits well with our existing lead drug candidate MangoralTM. With Oncoral, we now have two clinical stage medicinal product candidates in our pipeline and both candidates have the potential to become global leaders in their indications as they will have significant advantages compared to currently available products”, says Magnus Corfitzen, Chief Executive Officer of Ascelia Pharma.

Sunstone Life Science Fund II portfolio company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the Company’s lead product candidate, VXM01, has received orphan designation from the European Commission and from the US Food and Drug Administration (FDA) for the treatment of glioma, a difficult-to-treat form of brain cancer. Orphan designation is designed to encourage the development of drugs to treat rare diseases and conditions and provides companies with certain incentives, including periods of market exclusivity upon approval, as well as user fee reductions or exemptions. The designation by the European Commission is for the treatment of glioma and by the US FDA for the treatment of malignant glioma.

Sunstone Life Science Fund II portfolio Company Anergis, a company developing proprietary ultra-fast allergy immunotherapy, has announced the top-line results from the ATIBAR trial, a Phase IIb field-based clinical trial with Anergis’ lead compound AllerT for patients with birch pollen allergy.

A total of 421 patients were randomized at 38 European trial centers in Denmark, Finland, Germany, Lithuania, Norway, Poland, Slovakia and Sweden between September 2016 and January 2017. The trial met its objective to provide conclusive results, with well-balanced treatment groups, very few dropouts, and narrow confidence intervals of the observed treatment effects. The pollen exposure was satisfactory as assessed by the data collected from the pollen traps located close to the trial centers.

Sunstone Life Science Fund III portfolio company, Rigontec GmbH and MSD today announced that MSD will acquire all outstanding shares in Rigontec. Under the terms of the agreement, MSD will make an upfront cash payment of EUR 115 million to Rigontec’s shareholders; based on the attainment of certain clinical, development, regulatory and commercial milestones, MSD may make additional contingent payments of up to EUR 349 million.

Rigontec is a pioneer in accessing the retinoic acid-inducible gene I (RIG-I) pathway, part of the innate immune system, as a novel and distinct approach in cancer immunotherapy to induce both immediate and long-term anti-tumor immunity. Rigontec’s lead candidate, RGT100, is currently in Phase I development evaluating treatment in patients with various tumors.

Rigontec was founded in 2014 as a spin-out of the University Bonn, Germany, and has to date raised close to EUR 30 million.

Sunstone Life Science Fund III portfolio Company Cantargia AB has announced that the European Patent Office (“EPO”) has granted the company’s patent application on the product candidate CAN04. CAN04 is targeted against the molecule IL1RAP expressed in a large number of cancer diseases. The formal approval follows the intention to grant that EPO issued in April 2017.

The patent application with number 15714603.6 which was granted by the EPO, concerns the company’s product candidate CAN04. The patent protects CAN04 both as a substance as well for cancer treatment. The patent gives protection in Europe until 2035. In addition to the patent granted in Europe, a notice of allowance was obtained in the USA in June 2017. The application has also been submitted in a large number of additional territories such as Japan and China.

One of the highlights of the Emerging Technology Showcase Area at the European Society of Cardiology Congress in Barcelona, will be Swedish/Danish Acarix AB’s (publ) (“Acarix”) CADScor®System, an advanced, easy to use, frontline test to rule out Coronary Artery Disease (CAD) with high accuracy.  Initial study results released earlier this year show that the Danish Design Award winning CADScor®System non-invasively rules out CAD with 97% negative predictive value. Following this, the CADScor®System has been commercially launched in the Nordics and Germany to both private and public cardiology centers.

In addition to seeing demonstrations of the CADScor®System on booth F140 in the Emerging Technology Showcase Area, delegates will also be able to learn about study results from Principal Investigator Morten Böttcher, MD PhD FESC and Simon Winther, MD PhD, Department of Cardiology, Herning Hospital, Denmark.

Sunstone Life Science Fund II portfolio Company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the first clinical data in glioblastoma with its lead product candidate, oral VXM01, are being presented at the upcoming American Society of Clinical Oncology (ASCO) 2017 Annual Meeting being held June 2-6, 2017 in Chicago, IL, USA.

Sunstone Life Science Fund II portfolio company Orphazyme ApS, a Danish biotech company developing novel therapies for the treatment of protein misfolding diseases, has announced the completion of enrolment for its lead program within Niemann-Pick type C disease. Niemann-Pick type C disease (NPC) is one of several fatal lysosomal storage diseases and is affecting around 1 in 150,000 newborns. Although symptom onset and progression is highly variable, NPC is most often diagnosed in childhood and adolescence. Impaired breakdown and recycling of lipids in cells of affected individuals leads to malfunction and demise of cells in the brain and other organs, which results in seizures, progressive loss of muscle control and intellectual capacity.

Sunstone Life Science Fund II portfolio company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company which in the US and Canada operates as EMD Serono, and Pfizer Inc. (NYSE: PFE) to evaluate avelumab*, a human anti-PD-L1 antibody, in combination with VAXIMM’s VXM01. VXM01 is an investigational oral T-cell immunotherapy designed to activate T-cells to attack the tumor vasculature, and, in several tumor types, attack cancer cells directly. Under the terms of the agreement, VAXIMM will be responsible for conducting two open-label Phase I/II trials – one in glioblastoma and one in metastatic colorectal cancer.

* Avelumab is under clinical investigation for treatment of glioblastoma and metastatic colorectal cancer and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for glioblastoma and metastatic colorectal cancer by any health authority worldwide.

Sunstone Life Science Fund III portfolio company Rigontec, the leader in RIG-I
targeting RNA therapeutics, has announced the dosing of the first patient in a phase I/II
study with intratumoral/intralesional administration of its lead compound RGT100 in solid
tumors and lymphoma. RGT100 targets the retinoic acid-inducible gene I (RIG-I) pathway,
one of the most essential pathways in the innate immune system to induce both immediate
and long-term anti-tumor immunity.

Sunstone Life Science Fund II portfolio company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that preclinical data for three of its programs will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 being held in Washington, DC, USA, April 1-5.

 

 

 Senior Pharma and Biotech Executive joins Anergis´ Board of Directors as New Chairman

Sunstone LSV Fund II portfolio company Anergis SA, a Swiss clinical-stage biopharmaceutical company developing proprietary products for ultra-fast allergy immunotherapy, today announced the appointment of Dr. Klaus Schollmeier as Chairman of its Board of Directors.

Mr. Schollmeier has been a senior executive and advisor to the pharmaceutical and biotech industries for more than 30 years and has senior leadership experience in R&D, Marketing as well as General Management.

F2G Ltd, a UK Biotech developing novel therapies for life threatening fungal infections, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species. Orphan drug designation will allow F901318 up to ten years market exclusivity following market authorisation in the EU.

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of John H. Rex, MD, FACP to the position of Chief Medical Officer, effective from 2nd November 2016.

Dr Rex is a distinguished research scientist and a key opinion leader in the field of infectious disease therapy, in particular antifungal agents. He held the position of Senior Vice President and Head of Infection, Global Medicines Development at AstraZeneca until October 2016. Prior to joining AstraZeneca in 2003, Dr Rex was Professor of Medicine at the University of Texas Medical School at Houston. Dr Rex has been the Industry Representative on the US FDA Anti-Infective Drug Advisory Committee (2007-2011), has served as Chair of the Consensus Committee on Microbiology for the Clinical Laboratory Standards Institute (CLSI, formerly NCCLS), is a member of the Wellcome Trust Seeding Drug Discovery Committee, was formerly an Editor for Antimicrobial Agents and Chemotherapy and currently serves on several editorial boards. He holds a BA in Biochemistry from Rice University as well as an MD from Baylor College of Medicine in Texas. Dr Rex has served as a non-executive director of F2G since September 2012 and is an Operating Partner at Advent Life Sciences.

OxThera AB, a Stockholm-based privately-held biopharmaceutical company, announces today that it has agreed on a EURO 32 million investment to complete the Oxabact® development program for treatment of Primary hyperoxaluria. The investment round is co-led by Life Sciences Partners, Netherlands, Ysios Capital, Spain, Sunstone Capital, Denmark, and Flerie Invest, Sweden, in addition to current shareholders Kurma Partners, France, Idinvest Partners, France, Stiftelsen Industrifonden, Sweden, and Brohuvudet, Sweden. This announcement bolsters OxThera’s position as a leader in developing therapies for Primary hyperoxaluria, a debilitating condition that, if untreated, leads to kidney damage and end-stage renal disease.

Alligator är ett forskningsbaserat bioteknikföretag som utvecklar innovativa immunaktiverande antikroppsläkemedel för tumörriktad immunterapi. Bolaget har sitt säte i Lund och hade 35 anställda per den 30 september 2016. Alligator är främst verksamt i de tidiga faserna av läkemedelsutvecklingen, från idéstadium till och med kliniska fas IIa-studier och Bolagets projektportfölj består främst av produktkandidaterna ADC-1013, ATOR-1015 och ATOR-1016. I augusti 2015 utlicensierades ADC-1013 till Janssen Biotech, Inc., ett Janssen-läkemedelsföretag inom Johnson & Johnson-koncernen, för vidareutveckling och kommersialisering. Bolagets aktier är noterade på Nasdaq Stockholm under kortnamnet ”ATORX”. För mer information, se http://www.alligatorbioscience.se.

För mer information, vänligen kontakta:
Per Norlén, VD
Telefon: +46 46 286 42 80
E-post: pen [at] alligatorbioscience [dot] com

Rein Piir, VP Investor Relations
Telefon: +46 708 537292
E-post: rpr [at] alligatorbioscience [dot] com

Informationen i pressmeddelandet är sådan som Alligator Bioscience AB är skyldigt att offentliggöra enligt lagen om handel med finansiella instrument.

Sunstone Life Science Fund III portfolio company Rigontec, the leader in RIG-I targeting RNA therapeutics, has announced that Dr. Jörg Vollmer has joined the Company as Chief Scientific Officer. Dr. Vollmer brings to Rigontec more than 17 years of drug discovery and development experience including leadership roles at Nexigen GmbH, Pfizer and Coley Pharmaceutical. Dr. Vollmer will be responsible for leading Rigontec’s R&D efforts and advancing the Company’s RIG-I-based platform focused on discovering and developing treatments for oncological and infectious diseases. He will report to Dr. Christian Schetter, CEO of Rigontec, and will be based in Munich.

 

 

F2G Ltd, the UK-based antifungal drug discovery and development company, has announced the publication of the initial F901318 data in the prestigious scientific journal Proceedings of the National Academy of Sciences (PNAS), of their work in elucidating the mechanism of action of its novel orotomide antifungal – lead candidate F901318. The study entitled “F901318 represents a novel class of antifungal drug that inhibits dihydroorotate dehydrogenase” can be found here: http://www.pnas.org/content/early/2016/10/24/1608304113.abstract

 

Anders Hinsby, CEO of Orphazyme ApS, says: “The whole team at Orphazyme has been working tirelessly to bring our technology and scientific advancements from the laboratory into the clinic. With Thomas Blaettler now on board, we will be well equipped to design and implement long-term clinical strategies, fulfilling our aim to improve the lives of those suffering with rare, and often fatal, diseases.”

A new treatment for a currently incurable group of inherited neurological diseases that affect 1 in 10000 children has been revealed, which works by triggering the body’s own ‘recycling’ system. New research by scientists at Orphazyme ApS, published in Science Translational Medicine, reveals a promising method to treat several diseases in the sphingolipidoses family of lysosomal storage diseases. These debilitating disorders, including Niemann-Pick type C, Fabry, and Sandhoff diseases, involve the accumulation of sphingolipids (fat molecules) in the cells and are often fatal during early childhood.

Sunstone Life Science Fund III portfolio company Rigontec, the leader in RIG-I targeting RNA therapeutics, has announced that it has secured EUR 15 million in a third and final closing of its Series A round. The financing represents additional capital from current investors Boehringer Ingelheim Venture Fund, Forbion Capital Partners, High-Tech Gründerfonds (HTGF), NRW.BANK, MP Healthcare Venture Management, Sunstone Capital and Wellington Partners Life Sciences. The funding will advance the ongoing development of Rigontec’s RIG-I agonist platform targeting oncological, anti-infective and inflammatory indications as well as accelerate the progress of lead candidate RGT100 towards the clinic.

Sunstone Life Science Fund II portfolio company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced the appointment of Matthias Schroff, PhD, as Chief Executive Officer (CEO).

Dr. Schroff has over fifteen years of experience in the biotechnology industry. Previously, he was CEO of Mologen AG, a publicly traded German biotech company, serving on the company’s executive board for over ten years. In the eight years that Dr. Schroff served as CEO, he built Mologen from an early preclinical stage to an established immuno-oncology company with programs in Phase 2 and 3 clinical trials. In addition to his position at Mologen, Dr. Schroff served on the Board of Directors of the biotech arm of the Association of Research-based Pharmaceutical Companies (vfA bio). During his career, Dr. Schroff has served in a variety of functions, including research, manufacturing, scientific collaborations, for example with the MD Anderson Cancer Center, clinical development, business development and investor relations. He is the inventor of numerous patents in the field of immuno-oncology, RNAi and gene expression, including a TLR9 agonist that is now in late-stage clinical development for various cancer indications. Dr. Schroff received his PhD in biochemistry from Freie Universität Berlin at the Institute of Molecular Biology and Biochemistry, where he was involved in clinical trials in immunotherapy against cancer as early as 1994.

Martin Olin, CFO and Deputy CEO, promoted to Chief Executive Officer

Sunstone Life Science Fund I portfolio company Symphogen, a private biopharmaceutical company developing recombinant antibody mixtures, announced today that Kirsten Drejer, M.Sc., Ph. D., Co-founder, Chief Executive Officer and Director will transition from an executive operational role to an independent member of the Board of Directors. In parallel, Martin Olin, M.Sc., E*MBA, now Chief Financial Officer, has been promoted effective 1st September to Chief Executive Officer and member of the Board of Directors. Kirsten Drejer is proposed to be elected to the Board of Directors as an independent member and will, through a transition period, be a working Board member assisting Martin Olin.

 

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Ralf Schmid to the position of Chief Financial Officer, effective from 4th July 2016. Ralf brings over 20 years’ experience to F2G, with considerable expertise in M&A, licensing, public and private market transactions.

Ralf Schmid joins F2G from Nabriva Theraputics AG (NASDAQ:NBRV), where he served on the management board since the company’s inception in 2006. In his role as Chief Financial and Chief Operating Officer, Ralf was instrumental in taking the company public on NASDAQ in September 2015. He has held various senior positions in finance and administration at several multi-national companies including Sandoz where he led the spin-off of Nabriva. Ralf holds a Master’s degree in finance and economics from Otto-Friedrich-Universität Bamberg, Germany.

 

Sunstone Life Science Fund II portfolio company VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, announced today the treatment and successful operation of the first patient in a Phase I clinical trial. The study, sponsored by VAXIMM, will initially enroll six patients with operable recurrence of a glioblastoma (brain tumor) and is being conducted at the University Hospital in Heidelberg, Germany.

 

 

 Sunstone Life Science Fund II portfolio company Orphazyme has announced that the FDA has granted Fast Track designation for the investigation of arimoclomol intended for the treatment of Niemann-Pick disease type C. The FDA’s Fast Track Program is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. “The Fast Track designation is really good news for everyone involved in the AIDNPC trial, not least the sufferers of Niemann-Pick disease type C who deserve that every effort is made to expedite development of promising new therapies”, says Orphazyme ApS CEO Anders Hinsby

 

Sunstone Life Science Fund II portfolio company Orphazyme announced today that the first two patients have been dosed with arimoclomol in the Phase III ‘AIDNPC’ Niemann-Pick disease type C clinical trial programme.

The first two patients in the NPC-002 Interventional Study of the AIDNPC clinical programme were enrolled at the Rigshospitalet site in Copenhagen, Denmark, marking a key milestone in the development of a new treatment option for Niemann-Pick disease Type C (NP-C) patients.

Dr. Thomas Hecht and Dr. Mathieu Simon join Board; Dr. Hecht appointed Chairman

Sunstone Life Science Ventures Fund II portfolio company VAXIMM AG, a Swiss-German biotech company focused on developing oral T-cell immunotherapies, today announced the election of Thomas Hecht, MD, and Mathieu Simon, MD, as new members to its Board of Directors. In addition, Dr. Hecht has been appointed as Chairman of the Board, taking over from Dr. Klaus Breiner, who will continue his role in the company as Vice-Chairman.

 

 

Funding to Take Lead Compound Through to Product Approval and Development of Pipeline Assets

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced that it has raised $60 million in financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections. The round was led by Sectoral Asset Management, with participation from Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences LLP, Novartis Venture Fund, Sunstone Capital and Merifin Capital each participated in the round.

 

Sunstone Life Sciences Fund II portfolio company Orphazyme has received a “Study May Proceed” letter from the FDA on Orphazyme’s protocol for arimoclomol as a new treatment for Niemann-Pick disease type C (NP-C), the AIDNPC intervention study. This makes the US Investigational New Drug Application (IND) effective, complementing the corresponding European Clinical Trial Application (CTA) submitted for the same protocol.

Orphazyme runs an international, multi-centre, double-blind intervention study enrolling approximately 46 NP-C patients to be treated with three daily oral doses of arimoclomol or placebo. The objective of the study is to determine the efficacy and safety of arimoclomol in the treatment of NP-C.

Sunstone Life Science Fund I portfolio company Zealand announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has discussed lixisenatide and  iGlarLixi for the treatment of adults with type 2 diabetes. Following the discussions, the Advisory Committee members voted 12 to 2 (with 1 non-vote) to recommend approval of the New Drug Application (NDA) for iGlarLixi in the US. The Advisory Committee was not asked by the FDA to vote on the approval of the NDA for lixisenatide.

Sunstone Life Sciences Fund II portfolio company Alligator Bioscience has received the SwedenBIO Award for ”exceptional achievements within the life-science industry”. This is yet another confirmation of Alligator´s success in the field. Alligator is a privately held Swedish biotech company with a pipeline of immune-activating antibodies for tumor-directed immunotherapy of cancer. Notably, in 2015 Alligator granted Janssen Biotech Inc, one of the Janssen Pharmaceutical companies of Johnson & Johnson, an exclusive, worldwide license to Alligator’s clinical candidate ADC-1013. Under the agreement Alligator receives an initial up-front payment and aggregated future milestones up to a potential total of 700 MUSD.

Sunstone LSV Fund II portfolio company VAXIMM AG, a Swiss-German biotech company focused on developing oral T-cell immunotherapies, today announced the appointment of Dr Jarl Ulf Jungnelius, MD, PhD to the newly created position of Chief Medical Officer.

Dr Jungnelius is a seasoned healthcare professional, having spent over thirty years practicing medicine and leading key drug development projects for international pharmaceutical companies, with a strong focus on oncology.

 

 

Sunstone Life Sciences Fund II company, Anergis, a company developing proprietary ultra-fast allergy immunotherapy, announced today that it has closed a CHF 5 million financing round extension with existing investors. In addition, the Company is preparing a Phase IIb clinical trial with its lead compound AllerT in patients with birch pollen allergy. The study is designed as a multicenter, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerT In Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis (ATIBAR). ATIBAR is expected to start in fall 2016. With a total of 450 patients, ATIBAR will be the largest field-based trial conducted so far with an ultra-fast allergy treatment for tree allergy.

 

Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, today announced a broad strategic immuno-oncology collaboration.

F2G Ltd, a UK based antifungal drug discovery and development company, today announced that its novel systemic antifungal product F901318 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways pilot programme.

Initiated in March 2014, the Adaptive Pathways pilot program forms part of the EMA’s strategy to provide improved access to new therapies treating serious conditions where there is a high unmet medical need.

Mr Ian Nicholson CEO said “We are delighted to have been accepted into the EMA Adaptive Pathways programme which has the potential to accelerate the approval process for F901318. This will ultimately lead to patients receiving our drug sooner than would normally be the case and will provide treatment options in settings where current choices are inadequate. We would like to thank the EMA and the European HTAs who contributed to the review and collaborative feedback on our proposal at recent EMA/HTA parallel scientific advice.”

 

Sunstone Life Science Ventures Fund I portfolio company Nuevolution A/S today announced that it has entered into collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, using Nuevolution’s proprietary Chemetics® drug discovery platform. The collaboration was facilitated by Johnson & Johnson Innovation, in partnership with Janssen Discovery Sciences.

 

 

Sunstone Life Science portfolio company Alligator Bioscience AB, a privately held Swedish biotech company developing immuno-oncology antibodies for directed immunotherapy of cancer, today announced that it has entered into a definitive agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Under the agreement, Janssen, will be granted an exclusive, worldwide license to Alligator’s clinical candidate ADC-1013. The collaboration was facilitated by the Johnson & Johnson Innovation Center in London. Currently in Phase I clinical trials, ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor. In addition, a tumor-specific memory is established leading to long term immunity to the cancer.

 

Rigontec GmbH, a privately held biopharmaceutical company developing RNA-based immunotherapeutics for the treatment of cancer and viral diseases, today announces that Dr. J. Donald (Don) deBethizy has been appointed as Chairman of the Board of Directors. He replaces outgoing Chairman Prof. Dr. Gunther Hartmann who co-founded Rigontec and led the Board since 2014. Prof. Hartmann will remain on the Board of Directors. Dr. deBethizy brings more than 30 years  of experience in research and development, as well as financial and operational management in the biotechnology and consumer products industry. He is currently President of White City Consulting ApS in Denmark and serves on the supervisory boards of arGEN-X NV (Euronext Brussels), Newron Pharmaceuticals SPA (SIX Swiss Exchange), Serendex Pharmaceuticals (Oslo Exchange) and Noxxon Pharma AG.

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis’ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.

Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.

 

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 μg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015.

 

Rigontec GmbH, a privately held biopharmaceutical company developing RNA-based immunotherapeutics for the treatment of cancer and viral diseases, today announces it has raised EUR 4.8 million in a second closing of its Series A financing round from Forbion Capital Partners, a Dutch life-sciences venture capital firm, and Sunstone Capital, a Copenhagen based venture capital investor. The new investment brings the total Series A to EUR 14.25 million and adds two further highly experienced investors to Rigontec’s investor base alongside Wellington Partners, Boehringer Ingelheim Venture Fund, NRW.BANK and High-Tech Gründerfonds (HTGF).

 

Life Science Venture Associate

Positive, analytical and well structured

Leading European Venture Capital fund

Autonomous, self-managing project leader to manage investment opportunities

Must chair internal deal flow meetings and provide first assessment of match with criteria

 

Please click link for full description

 

Egalet-001 met primary endpoint of reduced drug liking compared to MS Contin®
Egalet Corporation (Nasdaq: EGLT) (“Egalet”) today announced positive results from a Category 3 human abuse liability (HAL) study of Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The clinical HAL study demonstrated that in nondependent, recreational opioid users, the abuse potential of manipulated Egalet-001 taken orally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).

Orphazyme ApS today announced the successful completion of a 20 million Euro Series B financing round. Kurma Partners and Idinvest Partners join the existing investor syndicate of Novo A/S, Sunstone Capital and Aescap Venture.

 Orphazyme ApS develops novel therapeutics for the treatment of rare and genetic diseases. The company was founded on pioneering research on the therapeutic potential of the cellular heat shock response and is now developing a family of well-tolerated small molecule inducers of heat shock proteins as treatments for lysosomal storage diseases and other neurodegenerative diseases. A clinical Phase 2 study in Niemann-Pick Disease type C, a detrimental lysosomal storage disease, is currently in preparation.

 

Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced that it received a notice of allowance from the US patent authorities for its patent covering composition and methods of use of its ragweed allergy product AllerR. AllerR is based on Anergis’ unique Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceuticalgrade, long-peptide immunotherapeutics designed for an ultra-fast, safe and longlasting treatment of allergy patients. Ragweed pollen is believed to be the most allergenic of all pollens. Allergies to ragweed pollen are mostly prevalent in the USA, where they affect an estimated 27 million patients, with a high degree of severity in many of them. Among others, ragweed allergies are a major cause of asthma. Fifty percent (50%) of allergic patients in the United States are sensitized to ragweed. “Allowance of the patent on AllerR in the U.S. is a major milestone in broadening our international patent estate,” said Christophe Reymond, Chief Scientific Officer of Anergis.

Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.

 

Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the closing of a Series B financing round totaling CHF 14.5 million (€ 12.1 million, US$ 15 million). All Series A investors participated in the round together with new private European and U.S.-based investors. The financing was jointly led by existing investors Sunstone Capital, BioMedInvest and Renaissance PME as well as new investor WJFS, Inc. Anergis has so far raised a total of CHF 44 million in private equity, which includes the latest Series B financing round.

 

Pulmologix AB today announced the closing of a series B financing of EUR 9.6 million to develop a new Oral Non-Steroidal Anti-asthmatic (ONSA) for the treatment of early onset allergic asthma. The financing was led by Novo Seeds, the seed fund of Novo A/S, and Sunstone Capital of Denmark. Previous investors Forbion Capital Partners of the Netherlands and HealthCap participated in the round. “We are pleased to invest in Pulmologix and view this as an exciting opportunity in a common and undertreated disease” says Bobby Soni, Investment Director of Novo Seeds who together with Andreas Segerros of Sunstone now joins the Board of Directors.

Anergis, a company developing proprietary ultra-fast allergy vaccines, today reported positive long-term efficacy results with its lead compound AllerT, a novel birch pollen allergy vaccine. A total of 196 patients were enrolled in the Phase IIb follow-up, double-blind, placebo-controlled, field-based clinical trial. The trial objective was to evaluate the long-term efficacy of AllerT in patients who had participated last year in the fieldbased Phase IIb trial with AllerT. Patients evaluated this year either received a placebo, AllerT 50 μg or AllerT 100 μg 18 months before the second birch pollen season.

F2G Limited, the UK-based antifungal drug discovery and development company, has announced a major funding award from the Technology Strategy Board’s Biomedical Catalyst.
The prestigious £1.4 million award will expedite the development of F2G’s novel IV/oral systemic antifungal F901318. The Biomedical Catalyst project will focus on the oral Phase I clinical development of F901318 and supporting studies, and will allow the company to accelerate its clinical development activities.

Bristol-Myers Squibb Company (NYSE: BMY) and Sunstone Life Science Ventures Fund III portfolio company Galecto Biotech AB today announced that the companies, together with the Galecto shareholders, have entered into an agreement that provides Bristol-Myers Squibb the exclusive option to acquire Galecto Biotech AB and gain worldwide rights to its lead asset TD139, a novel inhaled inhibitor of galectin-3 in Phase 1 development for the treatment of idiopathic pulmonary fibrosis (IPF) and other pulmonary fibrotic condition. Total aggregate payments in agreement have the potential to reach $444 million, which includes the option fee, an option exercise fee and subsequent clinical and regulatory milestone payments.

Euro Diagnostica, a leader in diagnostic solutions for autoimmune diseases, has entered into a merger agreement with Sunstone Life Science portfolio company Biomonitor, a leading company in theranostics and personalized medicine. Biomonitor’s patented cell-based assay platform iLite™, based on reporter gene technology, can both monitor functional drug activity and detect neutralizing antibodies. This provides a unique and extremely versatile tool for optimizing patient treatment. Moreover, reporter gene technology can be used to customize assay development during different stages of biological/biosimilar development and manufacturing.

Cardiovascular Medical Device Industry Veteran to Lead JenaValve in Broader Commercialization of TAVI Systems for Treatment of Aortic Valve Disease.

JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, today announced that medical device industry veteran David J. Drachman has been named the Company’s new chief executive officer, effective immediately.

Nuevolution is very pleased to announce that Dr. Peter Hirth has joined Nuevolution as a Corporate Advisor. Peter brings 30 years of experience in biotechnology and pharmaceutical discovery to Nuevolution, explicitly from his tremendous successes with companies like SUGEN and Plexxikon.

“We are excited about having Peter join us as a Corporate Advisor”, said Alex Gouliaev, CEO of Nuevolution A/S. “Peter brings to Nuevolution a wealth of entrepreneurial experience and life science expertise. I am convinced that his expertise will strongly support our strategic direction of becoming a leading small molecule development company in the field of oncology and inflammation”.

 – Former Merck Serono Director brings strong expertise in drug development, product launches and life cycle management –

 Anergis, a company discovering and developing proprietary allergy vaccines, today announced that Vanya Beltrami, PhD, has joined the company as Director Product Development.

Dr. Beltrami brings over 20 years of experience in the pharmaceutical industry with Ares-Serono, Laboratoires Serono SA and Merck Serono SA, where he held several positions with direct product development responsibility (e.g. somatropin), acting as final dosage forms project director and manufacturing product director. Most recently, he was Global Product Team Leader at the Global Product Unit Endocrinology, where he substantially expanded his cross-functional pharmaceutical development experience.

 

 

Anergis, a company discovering and developing proprietary allergy vaccines, today announced it will present four scientific communications on its Contiguous Overlapping Peptides (COP) allergy vaccines at this year’s European Academy of  Allergy and Clinical Immunology Congress 2014 (EAACI) in Copenhagen, Denmark. The presentations focus on Anergis´ lead compound AllerT against birch pollen allergies, its house dust mite vaccine candidate AllerDM, and a general economic evaluation of allergen immunotherapy for seasonal allergies.

Anergis, a company discovering and developing proprietary allergy vaccines, today announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014. The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years. All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints. 

Evolva Holding SA (SIX: EVE, “Evolva” or the “Company”) has successfully completed its placement of shares which was announced yesterday. Evolva has sold 27,000,000 new shares via an accelerated bookbuild process by way of a private placement in Switzerland and outside of Switzerland in accordance with applicable securities laws. The shares have been placed at a price of CHF 1.37 per share, representing a discount of 4.9% to the closing price of 25 February 2014.

In addition, the Company has granted Credit Suisse, who is acting as Sole Bookrunner in the private placement, an over-allotment option of up to 4,050,000 additional shares which can be exercised within 30 days after the first trading day of the new shares on SIX Swiss Exchange.

 

Nuevolution A/S today announced that it has entered an exclusive license agreement with a subsidiary of Merck & Co., Inc., known as MSD outside the United States and Canada, for small molecule compounds targeting an undisclosed intracellular target for use as leads in Merck’s drug discovery and development.  

 

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that Sanofi (EURONEXT: SAN and NYSE: SNY) in its Q4 2013 earnings released today, announced that the clinical Phase III development program for LixiLan has been started.

LixiLan is the Fixed-Ratio combination of Sanofi’s Lantus® (insulin glargine), the world-wide most prescribed basal insulin, and Lyxumia® (lixisenatide), administered as single daily injection via a disposable pen. The Phase III program comprises two studies; LixiLan-O, evaluating the Fixed-Ratio combination of Lantus® and Lyxumia® in 1,125 patients insufficiently controlled on oral antidiabetics drugs (OADs), and LixiLan-L, evaluating LixiLan in 700 patients not at target on basal insulin.

Anergis, a company discovering and developing proprietary allergy vaccines, today announced the closing of a financing round totaling CHF 8 million. The financing was fully subscribed by existing investors and directors and was co-lead by Sunstone Capital, BioMedInvest and Renaissance PME/Vinci Capital.

The Institute of Cancer Research (ICR), London, Cancer Research Technology (CRT), London and Nuevolution A/S, Copenhagen have entered into a drug discovery collaboration to identify novel lead candidates for cancer treatment.

Researchers will use Nuevolution’s screening technology, Chemetics®, to screen libraries each of millions of DNA-tagged compounds to identify those that act on a key protein in the stress response pathway, which has an important role in cancer cell survival and resistance to cancer treatments. This state-of the-art screening technology allows potent drug leads to be identified quickly, accurately and from very large and complex compound mixtures.

The three-way deal between the ICR, Nuevolution and CRT, the commercial arm of Cancer Research UK, builds on an existing collaboration between CRT and Nuevolution, which aims to identify drug leads that block the activity of several challenging cancer targets of therapeutic interest. Under the new deal, the Cancer Research UK Cancer Therapeutics Unit at the ICR and Nuevolution will collaborate to screen a key target within the stress response pathway. Researchers from the Cancer Research UK Cancer Therapeutics Unit at the ICR will provide detailed insights and scientific expertise on the specific stress pathway target as well as their extensive experience in cancer drug discovery and development. Nuevolution will provide its proprietary Chemetics® technology, screening expertise and medicinal chemistry expertise to optimise drug candidates. .

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) announces that under its license agreement with Sanofi (EURONEXT: SAN and NYSE: SNY) covering Lyxumia® (lixisenatide) and any combination product including lixisenatide, a milestone has been achieved in the advance of LixiLan, the once-daily single injection Lantus® (basal insulin) / Lyxumia® (lixisenatide) combination product, towards start of Phase III development in the 1st quarter of 2014. The milestone relates to the approval of the first Phase III study protocol for LixiLan by a Health Authority, triggering a USD 15 million payment to Zealand. 

Anergis, a company focusing on proprietary allergy vaccines, today announced it was granted a Japanese patent on its key technology from the Japanese Patent Office. The patent #5389326 broadly covers the Contiguous Overlapping Peptide (COP) technology which is used by Anergis to define and select new products for the ultra-fast treatment of multiple allergies.

Anergis Appoints Dr. Dino Dina to its Board of Directors
– Company appoints seasoned US vaccine and biotech executive –

Anergis, a company focusing on proprietary allergy vaccines, today announced the appointment of Dino Dina, MD, to its Board of Directors. Dr. Dina brings extensive expertise in the research and development of vaccines for allergy, cancer and infectious diseases as well as in building successful US biopharmaceutical companies.

“We are delighted to welcome Dr. Dina as a board member of Anergis,” said Jacques-François Martin, Chairman of Anergis´ Board of Directors. “With his outstanding track record he will surely play an essential role in further advancing Anergis´ business strategy.”

 

CMC Contrast AB, a privately owned drug development company that is developing a targeted contrast agent for Magnetic Resonance Imaging (MRI), announced today that Orphan Drug Designation has been granted by the US Food and Drug Administration (FDA) for its liver specific contrast agent CMC‐001. The Orphan Drug Designation has been granted for CMC‐001 for use as a targeted contrast agent for diagnostic MRI for detection and localization of focal liver lesions in patients where gadolinium‐based contrast agents are contraindicated or cannot be administered.

Cancer Research Technology (CRT), the commercial arm of Cancer Research UK, and Denmarkbased drug discovery company Nuevolution A/S, have signed a collaboration deal to discover anticancer drug molecules targeting several key proteins. 

The collaboration aims to identify drug leads that block the activity of a number of challenging cancer therapeutic targets. This could lead to the development of first-in-class novel treatments for cancer patients. 

Through the partnership, drug candidate molecules which home in on selected targets will be identified by screening millions of diverse small molecules using Nuevolution’s proprietary Chemetics® technology. This uses innovative DNA labelling to enable small molecule drug screening – a method to identify small molecules which bind to a target protein – on an unprecedented scale.

This newsletter highlights the main points of development for Zealand Pharma in 2013 to date. It also provides an update on the status and outlook for Lyxumia®(marketed by Sanofi for the treatment of Type 2 diabetes) as well as on main pipeline assets, expected to drive mid-and long-term growth and value creation. Further, the news letter contains information on recent and expected news flow, together with a schedule of upcoming Zealand IR events as well as noteworthy scientific and clinical events and presentations.

Sunstone Capital Life Science Ventures portfolio company Anergis, focusing on proprietary allergy vaccines, reported today that a Phase IIb study of its lead compound AllerT met the primary endpoint of reducing the combined symptom and medication score with AllerT 50 μg during the birch pollen season. Moreover, the vaccine improved the quality of life and symptom scores with AllerT 50 μg and AllerT 100 μg. AllerT is a birch pollen allergy vaccine derived from the company´s proprietary Contiguous Overlapping Peptide (COP) technology platform, which is designed to provide ultra-fast allergy desensitization after only two months of treatment. 

Chiesi Group (“Chiesi”), a leading European pharmaceutical company, today announced that it has signed, through its UK affiliate, Chiesi Ltd., a definitive agreement with Sunstone Capital to acquire Zymenex Holding A/S and its related group of companies (“Zymenex”), a biopharmaceutical group focused on research and development of innovative biologic therapeutics for the treatment of rare and life threatening genetic diseases. Terms of the transaction were not disclosed.

“Zymenex has from the very beginning focused on orphan drugs in the field of Lysosomal Storage Diseases. Patient focus and high quality research in all aspects of the development process are the basis  for the company’s success”, says Sten Verland, Chairman of the Board in Zymenex and partner with Sunstone Capital. “We are very pleased to hand over the ownership of Zymenex to Chiesi, and we believe that Chiesi through its regulatory expertise and worldwide commercial footprint has the resources needed to fully exploit the potential of Zymenex’ R&D for the benefit of patients with rare, serious, genetic diseases, for which there is no treatment available today”.

Opsona has announced that it has raised EUR 33 million in an oversubscribed Series C financing.

Opsona is developing new treatments for inflammatory diseases and will use the proceeds to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of its lead product OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF).

The participants in this Series C financing include new investors BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures and EMBL Ventures. BB Biotech Ventures, Sunstone Capital and Baxter Ventures will be joining the board of directors.

 

Biotech Company Orphazyme ApS today announces addition of new expertise to its Management Team and to its Board of Directors

Orphazyme is proud to present a significant strengthening of the Management and Board with the hire of Dr. Carlos Camozzi as new Chief Medical Officer (CMO) and the appointment of Dr. Georges Gemayel to the Board of Directors.

Dr. Camozzi brings extensive experience from more than 25 years in clinical research and development roles in pharma and biotech companies, including leading clinical operations in the rare disease area. Prior to joining Orphazyme ApS Dr. Camozzi was the VP-CMO of uniQure BV and before that a Medical Director and Head of Medical Affairs with Orphan Europe. Dr. Camozzi has a an MD and Ph.D. from the School of Medicine, National University of Buenos Aires (Argentina), and degrees in Paediatrics, Neonatology, Clinical Pharmacology and Neuropsychiatry.

Anders Hinsby, CEO of Orphazyme ApS, says: “We are very pleased that Dr. Carlos Camozzi has accepted the position as CMO; Carlos’ experience, particularly in the rare disease field, is an ideal match for Orphazyme, and we are happy that he joins us to lead our ambition of bringing the heat shock protein based programs successfully into and through clinical development.”

Orphazyme welcomes Dr. Georges Gemayel to its Board of Directors. Dr. Gemayel is a seasoned pharmaceutical and biotechnology company executive, and currently serves as Chairman of the Board of Vascular Magnetics Inc., as well as on the Board of Directors of NPS Pharmaceuticals. He previously served as Executive Chairman of Syndexa Pharmaceuticals and of FoldRx Pharmaceuticals Inc., President and Chief Executive Officer of Altus Pharmaceuticals Inc., Executive Vice President of Genzyme Corporation, Vice President of Roche Specialty Care, and General Manager of Roche Portugal. Dr. Gemayel received his Doctorate in Pharmacy at Saint Joseph University in Beirut, Lebanon, and earned a Ph.D. in Pharmacology at Paris-Sud University in France.

Continues Anders Hinsby: “Welcoming Dr. Georges Gemayel to the Board of Directors is a great pleasure. Georges has extensive experience from more than 20 years in the pharmaceutical and biotech industry, and a profound understanding of Orphan product development and commercialisation. The appointments of Dr. Carlos Camozzi and Dr. Georges Gemayel bring additional experience and energy to Orphazyme as we head towards clinical studies in 2014.”

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F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Dr. John H. Rex to the Company’s Board as an Independent Director. Dr. Rex is a distinguished research scientist and recognized as an opinion leader in the field of infectious disease therapy and, in particular, for antifungal agents. He has a BA in Biochemistry from Rice University, an MD from Baylor College of Medicine, and is Vice President and Head of Infection, Global Medicines Development, at AstraZeneca.

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it will present preclinical data for its ragweed allergy vaccine at the 2013 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, TX.* The results demonstrate the hypoallergenicity of AllerR and the successful recognition of the natural ragweed allergen Amb a 1 by the mouse immune system after immunization with AllerR.

The poster no. 136 will be presented on Saturday, February 23, 2013, at 9:45am CST in session no. 2210 “Immunotherapy I” at the Henry B. Gonzalez Convention Center, Street Level, Exhibit Hall C. The abstract of the poster titled “Non-Detectable IgE Binding of an Amb a 1 Derived, Contiguous Overlapping Peptide Based, SIT Product Candidate Against Ragweed Allergy” is available at:

http://download.journals.elsevierhealth.com/pdfs/journals/0091-6749/PIIS0091674912028163.pdf

AllerR is a mix of seven Contiguous Overlapping Peptides (COPs) derived from the COP platform of Anergis. In the experiments, AllerR showed no detectable IgE binding in competition ELISA tests using sera from allergic patients and did not induce degranulation of humanized basophil cells, a standard test used to test the ability of a protein or peptide to elicit an allergic reaction in humans. In addition, mice sensitized to the natural allergen Amb a 1 showed no reactivity to AllerR, whereas the administration of Amb a 1 in these animals lead to anaphylactic responses. The immunogenicity of AllerR was also tested in naïve mice and showed that each COP composing AllerR elicited an antibody response and that these antibodies specifically recognized the natural Amb a 1 allergen.

“We have shown that antibodies raised against AllerR in mice recognize Amb a 1 and that each COP contributes to AllerR immunogenicity,” said Christophe Reymond, Chief Scientific Officer of Anergis. “Combined with its absence of any detectable binding to IgEs of allergic patients, these properties make AllerR an excellent candidate for development of a novel COP allergy vaccine against ragweed pollen allergy.”

“We received positive feedback from the U.S. FDA last year when we discussed the AllerR early development program and the preparation of the first clinical trial of AllerR in patients allergic to ragweed pollen,” added Vincent Charlon, CEO of Anergis. “Our goal is to start a Phase I/IIa clinical trial in 2014.”

In the U.S., ragweed pollen allergy is the major cause of hay fever: 75% of all patients suffering from pollen allergies carry a ragweed pollen allergy. It affects about 20% of the U.S. population and is also on the rise in Europe due to the spread of ragweed (Ambrosia genus) plants accidentally introduced to Europe. The major allergenic protein has been identified as Amb a 1, a 38 kDa non-glycosylated protein composed of two subunits.

 

*The poster entitled “Non-Detectable IgE Binding of an Amb a 1 Derived, Contiguous Overlapping Peptide Based, SIT Product Candidate Against Ragweed Allergy” is also being published in The Journal of Allergy and Clinical Immunology – February 2013 (Vol. 131, Issue 2, Supplement, Page AB37, DOI: 10.1016/j.jaci.2012.12.815)

Company Appoints Gilles Della Corte as Director of Clinical Development and Eva Castagnetti as Director of Product Development.
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, today announced the expansion of its management team. With the appointments of Gilles Della Corte as Director of Clinical Development and Eva Castagnetti as Director of Product Development, the company has significantly strengthened its late-stage drug development expertise.

Gilles Della Corte, MD, brings to Anergis extensive expertise in global clinical development. In the past 22 years, he worked both for pharmaceutical companies, including Rhone-Poulenc Rorer, Servier, Solvay Pharma, Serono and Merck Serono, and for CROs where he held various senior positions in Research and Development. He has significant experience with all stages and aspects of clinical drug development ranging from Phase I to Phase IV. A cardiologist and pharmacologist by training, Gilles also holds diplomas in statistics and clinical trial methodology.

Eva Castagnetti, PhD, has several years of experience in both technical and business management functions in the biopharmaceutical industry with Lonza, Senn Chemicals and Rapid Pharmaceuticals. She has been responsible for the development and production of Active Pharmaceutical Ingredients (peptides) in early to late clinical phases, gaining comprehensive experience of the regulatory and quality requirements in the development of new pharmaceutical products. Eva obtained her PhD in organic chemistry in 2001 from the University of Lausanne/EPFL and spent two years as a postdoctoral fellow at the Massachusetts Institute of Technology (Cambridge/Boston) and at the ETH Zurich.

“Anergis has evolved into a clinical-stage company with several product candidates. We expect to report Phase II results of our large, randomized, controlled European trial of AllerT in Q3, 2013. With the appointments of Gilles Della Corte and Eva Castagnetti, Anergis has gained significant product and clinical development expertise, which will both be essential for the future clinical development of AllerT as well as for our expanding product pipeline,” said Vincent Charlon, CEO of Anergis.

Sunstone Life Science Ventures announced today that it has made a new investment from its Early Engagement Program (EEP). Sunstone has invested EUR 500,000 in ARO Medical, a private medical device company developing a novel implant for use in herniated disc surgery. ARO Medical, originally a US-based company, has moved all its activities to Aarhus, Denmark, and will apply the funding to conduct a clinical trial in Denmark.

Zymenex in Phase 3 clinical trial in patients with the rare disease alpha-Mannosidosis

Phase 2 trials demonstrated that the enzyme is clinically effective, safe and well tolerated and a placebo-controlled Phase 3 clinical trial is now underway.

Use of the biotechnologically derived human enzyme product rhLAMAN (LamazymTM), produced by the Danish biotech company Zymenex and developed for the treatment of patients suffering from alpha-Mannosidosis, has been successfully evaluated in a 12 month dose/response Phase 2a clinical trial and a 6 month follow-up Phase 2b clinical trial in 9 patients. The aim of the trials, which took place at the Department of Clinical Genetics, Copenhagen University Hospital, Denmark, was to confirm the chosen weekly minimum effective dose of 1 mg/kg and to validate the clinical effect of repeated i.v dosing.

Positive changes from baseline after 18 months of dosing have been demonstrated in the primary measured clinical and biochemical endpoints.

Statistically significant changes were demonstrated in oligosaccharide levels in serum, in the functional tests: 3 Minute Stair Climb (+39 steps, p=0.004) and 6 Minute Walk Test (+71 meters, p=0.009) as well as in the Leiter-R test of intellectual capacity (+0.5, p=0.022). The forced vital capacity (FVC), lung function test showed a marked increase (+9.2%, p=0.157) .

A 12-month, Multi-Center, Double-Blind, Randomized and Placebo-Controlled trial in 25 patients with alpha-Mannosidosis, receiving a dose of 1 mg/kg weekly, is now been initiated in Denmark, Germany, France, Spain, Belgium and Norway. The dosing will take place in the patient’s home countries and all evaluations will be performed at the Department of Clinical Genetics, Copenhagen University Hospital, in Denmark.

Alpha-Mannosidosis is a rare inherited disease, with a prevalence of 1 in 500,000 people. The disease is due to a rare inborn disorder that causes a lack of the lysosomal enzyme α-Mannosidase, resulting in increased levels of oligosaccharides and in severe skeletal- and muscle changes, hearing loss and recurrent infections and mental retardation. The disease belongs to the group of lysosomal disorders, for which Zymenex has a documented research competence.

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) announces that its partner, Sanofi (EURONEXT: SAN and NYSE: SNY), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), recommending the approval of once-daily Lyxumia® (lixisenatide) for the treatment of adults with Type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control

 European Patent rights covering use of HSP70 for the treatment of lysosomal storage diseases registered in 21 European countries

Orphazyme ApS today announced that the recently granted European Patent No. EP 2 318 032 B1 has taken effect in 21 countries across Europe, including United Kingdom, Germany and France.

Orphazyme develops therapies for the treatment of genetic disorders. The lead program is in preclinical development for the treatment of lysosomal storage diseases. Currently, only few treatment options exist for this family of serious genetic disorders, of which most are currently untreatable and often fatal, thus representing a significant unmet medical need. Orphazyme has applied its discovery capabilities to building a proprietary platform used for a novel and paradigm-changing approach to developing new treatments for these serious diseases.

The granted European Patent covers broadly the use of HSP70 for the treatment of lysosomal storage diseases including Gaucher, Fabry, Niemann-Pick and Krabbe disease.

Anders Hinsby, CEO of Orphazyme, says: “‘The grant of the European Patent is a major milestone for the company; it validates the very high innovative level of our technology and positions us well to further develop heat-shock protein based therapeutics for the treatment of lysosomal storage diseases.”

 

Dr. Prieels is a renowned industry expert in the vaccine field. He held various executive positions at GlaxoSmithKline, where he headed the vaccine research and development in Rixensart, Belgium, among others.

Dr. Prieels, who joined GlaxoSmithKline Biologicals (formerly SmithKline Beecham Biologicals) in 1987, has been instrumental in developing several marketed vaccines, including cervical cancer vaccine Cervarix™, Rotarix™ to protect from rotavirus infection, and Synflorix™ for the prevention of pneumococcal infections. He retired from GSK as Senior Vice President Research and Development in early 2011 and is currently a board member of several biotech companies in the vaccine field.

Under the terms of the agreement Abbott will acquire Action Pharma’s compound, AP214, in Phase 2b development for USD 110 million up-front.

Partner in Sunstone Capital, Sten Verland, is pleased with the agreement and states:
“The development of AP214 has demonstrated that innovation and world-class research are prerequisites for a successful development of new drugs to the benefit of patients. However, it is in the combination with a focused strategy and a strong management team, that scientific achievements can be turned into successful exits.”

Sunstone Capital press release (Danish)

Sunstone Capital press release (Swedish)

Abbott and Action Pharma joint press release

Action Pharma press release

David Solomon, CEO and President of Zealand Pharma commented on the report:

“During the first months of 2012, we have further strengthened our cash position alongside important progress for our pipeline of peptide drug candidates. Our partner, Sanofi, completed the global Phase III program, GetGoal, for lixisenatide (Lyxumia®) – now in the registration phase in Europe – with positive results from the GetGoal-P study supporting the intended use of this novel once-daily GLP-1 in the treatment of patients Type 2 diabetes.

We look forward to a response from the European Authorities on lixisenatide and to Sanofi’s planned filing in the US later this year while we concentrate on advancing the development of our internal peptide drug programs.”

Zealand Pharma A/S announces that Sanofi today in its Full Year 2011 results announcement reported positive top line results from the GetGoal-P Phase III study. GetGoal-P is one of the studies in the global GetGoal Phase III program for lixisenatide, a once-daily investigational GLP-1 agonist for the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to Sanofi.

Claus Andersson, PhD, has been promoted to join the partner group. Claus has worked as Investment Director at Sunstone Capital since 2005. He holds a strong background in strategy development, execution and technology development of medical technologies and diagnostics, e.g. novel sensors, molecular chemistry, quantification, and monitoring systems. While at Sunstone, he has led and managed investments in a number of companies including e.g. Santaris Pharma and is furthermore part of the Sunstone deal flow team.
Andreas Segerros has been working together with the Sunstone Capital Life Sciences team since 2007 as a venture partner and has been serving as Chairman of the Sunstone Business Development Board since its inception in 2008. Most recently, Andreas held the position as Vice President, Global Business Development and Operations Planning at Ferring Pharmaceuticals, a multi-national biopharmaceutical company.

Andreas brings to Sunstone Capital more than 20 years of commercial and development experience in the international pharmaceutical industry and has held a number of positions relating to strategic marketing and business development across Europe, the US and Japan.

Peter Benson, Managing Partner in Sunstone Capital Life Science Ventures: “After the first close in our LSV Fund III the team is now in place to identify and build truly unique companies”.

Zymenex enzyme moves into Phase 2b clinical trials in patients with the rare disease alpha-Mannosidosis

Phase 2a trial demonstrated that the enzyme is clinically effective, safe and well tolerated and a confirmatory Phase 2b clinical trial is now underway.

  The biotechnologically derived human enzyme product rhLAMAN (LamazymTM), which is produced by the Danish biotech company Zymenex and developed for the treatment of patients suffering from the rare disease alpha-Mannosidosis, has successfully completed the dose/response Phase 2a clinical trial and has now initiated a 6 month Phase 2b clinical trial in 9 patients, where the aim is to confirm the chosen minimum effective dose of 1 mg/kg dosed weekly and to validate the clinical effect of repeated i.v dosing.

  Alpha-Mannosidosis is an inherited, genetic, rare disease, with a prevalence of 1 in 500,000 people. The disease is due to a rare inborn disorder that causes a lack of the lysosomal enzyme α-Mannosidase (LAMAN), resulting in mental retardation, severe skeletal- and muscle changes, hearing loss and recurrent infections. The disease belongs to the category of lysosomal illnesses, that Zymenex has documented research competence in and has previously produced results within.

  “The clinical trials are sponsored by a €5.9 million EU Framework 7 grant, www.alpha-man.eu  and the Phase 1 and Phase 2 trials are performed at the Department of Clinical Genetics, Rigshospitalet in Denmark,” says Jens Fogh, President and CEO of Zymenex A/S. “The goal of the clinical trials is to make a future therapy available for ALL alpha-Mannosidosis patients.”

Sunstone Capital today announces the first closing of its Life Science Ventures Fund III (LSV III) raising a total of €89 million. The target is a €100 million final closing during 2012. Sunstone Capital aims to invest the majority of the fund in the Nordic countries, Germany and Switzerland.

The investment focus of the new fund is on private companies developing novel drugs, medical devices and diagnostics with high unmet medical needs. These sectors are driven by the pharmaceutical industry’s continued need to supplement their pipelines as well as by patient demand for safer and more effective drugs and treatment regimens.

The US Food and Drug Administration (FDA) has, on December 12, 2011 granted the Danish biotech company ACE BioSciences A/S (a subsidiary of Zymenex Holding A/S) Orphan Drug Designation for its recombinant human enzyme Galaczym, for the treatment of the rare, lysosomal disease Globoid Cell Leukodystrophy (Krabbe Disease). Orphan designation qualifies the sponsor of the product for fee reductions, protocol assistance and access to fast track approval and 7 years marketing exclusivity once the product has been approved for the market, according to the US Orphan Drug Act. Zymenex has already received Orphan Drug Designation in the EU for Galaczym in September 2011 and has previously received Orphan Drug Designation in both the EU and US for two other lysosomal enzyme products, Metazym for the treatment of Metachromatic Leukodystrophy and Lamazym for alpha-Mannosidosis, which has recently, successfully completed Phase 2a clinical trials.

Globoid cell leukodystrophy (also known as Krabbe disease) is a hereditary disease that is caused by the lack of an enzyme (a specialised type of protein) called galactocerebrosidase (GALC). This enzyme is needed to break down certain fatty substances including two lipid substances called galactosylceramide and psychosine. The accumulation of these substances is thought to destroy the cells that produce myelin, the protective sheath that surrounds the nerve cells, resulting in nerve damage in the brain and other parts of the body. The symptoms include extreme irritability or hypersensitivity, spasticity, and developmental delay. The symptoms and signs of central nervous system involvement are severe and intellectual deterioration is seen, leading to lack of voluntary movement and contact with the surroundings. Krabbe Disease is a long-term debilitating disease that can be life-threatening particularly in the early onset form, which typically leads to death in early infancy.

I løbet af de næste år forventer Sunstone Capital at udvide porteføljen med op mod 20 nye innovative biotekvirksomheder, og bringer dermed den samlede biotek portefølje op på næsten 50 virksomheder.

“Mange nordiske biotekvirksomheder har svært ved at finde kapital. Med den nye fond er vi nu klar til at investere i de dygtigste opstartsvirksomheder i branchen,” siger Peter Benson, managing partner i Sunstone Capital.

Sunstone fund II portfolio company VAXIMM has announced the start of the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01.

The placebo-controlled phase I dose escalation study intends to enroll up to 45 pancreatic cancer patients at the Heidelberg University Hospital (Heidelberg, Germany).

First patients have already been enrolled. In addition to standard-of-care treatment, the patients will receive several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.

Zealand Pharma’s President and Chief Executive Officer, David Solomon, commented:

“The European submission is a major achievement, bringing lixisenatide into the final phase before market launch, and represents a transformational milestone for Zealand Pharma. The GetGoal program has established clinical support for broad use of lixisenatide as a monotherapy and as an add-on to existing treatments, including in combination with basal insulin. We are confident that the drug will quickly find an important role in the management of Type‐2 diabetes.”

The biotechnologically derived human enzyme rhLAMAN (LamazymTM), which is produced by the Sunstone Life Science Fund I portfolio company Zymenex and developed for the treatment of patients suffering from the rare lysosomal storage disease alpha-Mannosidosis, has successfully completed a Phase 2a clinical trial.

Sunstone Life Science Fund I portfolio company Zymenex is engaged in the research and development of innovative therapeutics for life threatening diseases, such as Krabbe disease, a hereditary disease that is caused by the lack of an enzyme (a specialised type of protein) called galactocerebrosidase (GALC).

Zymenex was 27 September granted EU Orphan Drug Designation for its recombinant human enzyme Galaczym for the treatment of Krabbe disease.

The study demonstrated that AP214 is safe, reduces kidney injury, and improves long-term (90 days) outcomes on a composite end point (death, dialyses and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury. In addition, this study validates and expands on previous positive AP214 safety and efficacy data from a phase IIa trial.

Partner in Sunstone Capital, Søren Lemonius, states that: “The collaboration with Boehringer is yet a verification of the novelty and value add of Nuevolution’s technology in discovery of new drug leads, Nuevolution continues to receive attractive technology access fees and access to future upsides, as their technology offers more and better drug leads and Nuevolution controls the IP within the field.”

Sunstone Capital portfolio company Orphazyme develops innovative new therapies for the treatment of a family of serious genetic disordes called lysosomal storage diseases.genetic disordes called lysosomal storage diseases.
Orphazyme is based on discoveries emerging from the academic laboratory of its scientific founders: Professor Marja Jäättela and Thomas Kirkegaard Jensen. Their pioneering work on the cytoprotective properties of human heat shock proteins provides a novel and paradigm-changing approach to developing medicines for the treatment lysosomal storage diseases.

Dr. Arsalan Kharazmi, CEO of Biomonitor, states: “We are pleased and enthusiastic about our collaboration with Phadia. It allows Biomonitor to take advantage of our many years of experience in cell-based assays and in monitoring patients and to employ our patented iLite™ reporter gene technology globally with the help of an outstanding diagnostic company.

We are convinced that biotherapeutic drug monitoring will increase treatment efficacy, save money for the health care systems, and result in better patient care.”

The final patient has performed the last visit of the study period in Action Pharma’s US and Denmark based phase IIb study.

Treatment with AP214 is designed to investigate whether acute kidney injury can be prevented in patients undergoing major cardiac surgery – a serious unmet medical need with no treatment currently available on the market. Top line results from the study are expected to be reported as planned, in September 2011.

Sunstone Capital portfolio company Zealand Pharma (NASDAQ OMX: ZEAL), a Copenhagen based biopharmaceutical company, and Boehringer Ingelheim, one of the world’s leading pharmaceutical companies, jointly announced an exclusive global licence and collaboration agreement for dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with Type-2 diabetes and patients with obesity.

As part of the agreement, Boehringer Ingelheim obtains global development and commercialisation rights to ZP2929, Zealand Pharma’s lead glucagon/GLP-1 dual agonist drug candidate. Zealand Pharma will be responsible for conducting the first Phase I study with ZP2929 and Boehringer Ingelheim will fund the research, development and commercialisation of products under the agreement.

Sunstone Capital portfolio company Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, announced that it has advanced a second drug from its cardiometabolic program for the treatment of high cholesterol.

Sunstone Capital portfolio company Orphazyme today announced the purchase of CytRx’s molecular chaperone technology including the drug candidate arimoclomol, which is an orally administered heat shock protein amplifier that has been proven safe and well tolerated through several Phase I and multiple Phase II clinical trials.

The acquisition will provide Orphazyme with the opportunity of applying the small molecule chaperone technology to the development of novel treatments of inherited diseases such as lysosomal storage diseases.

Sunstone Capital portfolio company Action Pharma announces completion of dosing in phase IIb clinical trial with its leading development candidate AP214. Efficacy and safety data are expected during the third quarter of 2011.

Investment Manager Magnus Corfizen, Sunstone Capital, says: “Nordic Vaccine has built a portfolio of intellectual property rights with apparent synergies with Isconova’s technologies and product portfolio. As the main shareholder in Nordic Vaccine A/S we are enthusiastic to take part in this Scandinavian consolidation and become shareholder in Isconova AB, which we believe is a promising international company within adjuvants and vaccines”.

The agreement will aid Atonomics in the development of near patient tests on the New Atolyzer (R) platform.

CEO Thomas Warthoe states: “We are extremely pleased to enter into this agreement with Beckman Coulter, a company dedicated to high quality central laboratory testing with a global leadership position in immunoassays”.

Asante Solutions’s insulin pump, Pearl, is the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante Solutions has begun discussions with potential distribution partners in Europe.

Anergis SA is a clinical-stage biopharmaceutical company developing innovative immunotherapies against allergies. Its lead product, called “AllerT” and made of socalled Contiguous Overlapping Peptides (COPs), is designed to provide ultra-fast and safe desensitization to birch pollen allergy, a widely spread condition in developed countries.

Sunstone Capital co-lead the CHF 18 million Series A round along with Swiss investors Vinci Capital-Renaissance PME and BioMedInvest.

Orphazyme raises DKK 22M
Sunstone Capital joins Novo A/S as investors in the company founded in 2009.

Partner Sten Verland comments: “We are happy to join Novo as co-investors in Orphazyme. Their innovative approach promises to deliver new treatments for a number of lysosomal storage diseases. The orphan drug indication area fits well into our investment strategy, and we are looking forward to follow the progress of the company’s lead project toward clinical testing”.

Sunstone Capital joins Novo A/S as investors in the company founded in 2009.

Partner Sten Verland comments: “We are happy to join Novo as co-investors in Orphazyme. Their innovative approach promises to deliver new treatments for a number of lysosomal storage diseases. The orphan drug indication area fits well into our investment strategy, and we are looking forward to follow the progress of the company’s lead project toward clinical testing”.

Sunstone Capital portfolio company Zealand Pharma, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs that recently listed on NASDAQ OMX Copenhagen, was pleased to note that its partner, sanofi-aventis, today announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.

Sunstone Capital portfolio company Zymenex, the biotech company engaged in the research and development of innovative therapeutics for life threatening diseases, has announced the successful completion of phase I trials for its enzyme developed for the treatment of patients suffering from the rare disease alpha-Mannosidosis, and has now entered into phase IIa clinical trials.

This month, Sunstone Life Science Ventures Fund II invested in Acarix’s device for fast and accurate diagnosis of coronary artery disease.
Acarix A/S has developed a non-invasive screening method for detection of Coronary Artery Disease, CAD. The product will be rolled out to specialists first, and in a few years the product will be offered in a rugged and robust version to general practitioners. The diagnostic device is based on advanced algorithms and audible detection of abnormal heart sounds. CAD is today globally responsible for 20% of all deaths, and knowledge on disease progression will be invaluable to personal health and disease control.

ACARIX A/S is a spin-out from Coloplast A/S (Denmark) and is based on intellectual assets acquired from Aalborg University. Sunstone Capital lead the process and attracted fellow investors Seventure Partners (France) and SEED (Denmark) to the syndicate. The company expects conclusion on its 470 patients trial by July 2011.

TD Vaccines specialising in travellers’ diarrhoea, announces that ACE527, its oral, dual-action, ETEC vaccine candidate to combat the most frequent cause of bacterial diarrhoea in travellers, has significantly decreased the level of bacterial infection and the incidence and severity of diarrhoea in a Phase II study in which volunteers were challenged with ETEC after receiving the vaccine.

“These results are very encouraging because the challenge consisted of a dose of bacteria much higher than what individuals are typically exposed to when they are naturally infected,” commented Ingelise Saunders, TD Vaccines’ CEO. “The oral formulation, dual mechanism of action, and broad spectrum coverage offered by ACE527 makes it a very attractive commercial opportunity. According to the World Health Organization, ETEC is endemic in over 150 countries, and around 10 million travellers are estimated to contract ETEC annually. We estimate that the ETEC vaccine market potential is EUR 500 million. Our next step is to find a commercial partner with the skill set to fully capitalise on the vaccine’s potential.”

It is the first time that EU Framework programs grant support for clinical trials.

The Danish-Swedish biotech company Zymenex A/S is the industrial partner, in the EU’s Framework Program 7 supported ALPHA-MAN project, together with Christian-Albrechts-Universitet in Kiel, Germany, Copenhagen University Hospital in Copenhagen, Denmark and 9 other European partners, that now have received € 5.9 million in an EU grant for clinical trials, of the recombinant enzyme replacement therapy (ERT) developed by Zymenex, for patients suffering from the rare disease alfa-Mannosidosis. This is the first time that EU grants support for clinical trials in patients.

Alfa-Mannosidosis is an inherited, genetic, rare disease, with a prevalence of 1 in 500,000 people. Zymenex has Orphan Designation for their recombinant enzyme in both EU and USA. The disease belongs to the category of lysosomal illnesses, that Zymenex has documented research competence in and has previously produced results within. EU has also supported alfa-Mannosidosis research projects in their 5th and 6th framework programs – under the designations EURAMAN and HUE-MAN.

“Three clinical trials will now be performed with our biotechnologically derived human enzyme product rhLAMAN (LamazymTM). The first studies will be performed at the Department of Clinical Genetics, Rigshospitalet in Denmark and the following studies at hospitals in the UK, Germany, France and Poland” says Jens Fogh, President and CEO of Zymenex A/S. “The goal of the ALPHA-MAN project is to make a future therapy available for ALL alfa-Mannosidosis patients and thereby considerably improve the patients life expectancy and their quality of life.”

Zealand Pharma successfully raised EUR 50M, subject to the exercise of the over-allotment option, at an offer price of DKK 86 per share; valuing Zealand at DKK 2.3B.

Since its inception in December 1998, Zealand’s scientists have built a strong and growing pipeline of novel peptide drug candidates, many of which are now in clinical development. Currently, Zealand Pharma and its partners have two drug candidates in Phase III clinical development and four drug candidates in Phase I and Phase II clinical development. As part of the Company’s operations, Zealand Pharma has formed development partnerships with leading pharmaceutical companies: sanofi-aventis, Wyeth (now a subsidiary of Pfizer) and Helsinn Healthcare.

CEO of Zealand Pharma, David Solomon, commented on the IPO: “At Zealand Pharma we look forward to building a successful peptide drug company which both improves the treatment of patients across our therapeutic areas and delivers attractive value to our shareholders.”

Zealand Pharma A/S, a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs for the treatment of metabolic diseases such as diabetes and obesity, as well as cardiovascular and gastrointestinal diseases, today announces its intention to commence an initial public offering (“IPO”) and sets the indicative price range of its shares for their admission to trading and official listing on NASDAQ OMX Copenhagen.

Santaris Pharma A/S initiates Phase 2a clinical trial with miravirsen (SPC3649) to assess safety and tolerability in treatment-naïve patients with chronic Hepatitis C. Miravirsen is the first microRNA-targeted drug to receive Investigational New Drug acceptance from FDA.

Developed using Santaris Pharma A/S LNA Drug Platform, miravirsen inhibits miR-122, a microRNA important for Hepatitis C viral replication, thereby reducing the levels of Hepatitis C virus. Due to the unique mechanism-of-action, miravirsen holds promise as new (combinatorial) treatment option for Hepatitis C patients, including the 50% of patients not responsive to current standard of care.

Biomonitor, a leader in theranostics which combines the development of innovative and proprietary clinical bioassays with the capabilities of a state-of-the-art clinical reference laboratory, has entered into partnership with ARUP Laboratories in the monitoring of multiple sclerosis patients treated with interferon-beta.

CEO of Biomonitor, Dr Arsalan Kharazmi, states that the partnership “allows Biomonitor to take advantage of our many years of experience in monitoring multiple sclerosis patients and to employ our patented iLite TM report gene technology in the U.S. market with the help of an outstanding clinical referencelab.”

NsGene, which develops novel biological products for the treatment of neurological diseases, has announced the signing of a new and expanded agreement granting Biogen Idec exclusive rights to commercialise Neublastin for all indications and in all formulations.

Teit E. Johansen is pleased with the new agreement and states: “This agreement is further evidence that our unique pipeline of proprietary neutrophic factors continues to add vaule to NsGene and its shareholders.”

The agreement has been elevated to supply for the development and commercialization of Lixisenatide in combination with sanofi-aventis’ recombinant insulin analog.

David Solomon, Chief Executive Officer and President of Zealand Pharma comments on the agreement: “We are delighted that sanofi-aventis has reinforced its long and successful relationship with Zealand Pharma. This agreement not only strengthens Zealand’s financial position, allowing us to progress our other pipeline programs, but also provides significant excitement globally around a superior treatment for patients suffering with Type-2 Diabetes. Our focus at Zealand continues to be to build shareholder value through the development of leading peptide-based drugs.”

Sunstone Capital portfolio company JenaValve Technology, a medical device company specialized in developing minimally-invasive heart valve replacement systems has closed on a EUR 19M series B round led by two co-lead-investors, Sunstone Capital and VI Partners AG, Switzerland.

Sunstone Capital has signed an investment agreement with IMIX, an end-user provider of superior digital radiography. Simultaneously IMIX and ARCOMA AB, a leading OEM supplier of medical and radiology systems and sub-systems, have signed a Letter of Intent to combine the activities of the two companies in a single holding company, IMIX Holding AB. The combined company will become a leading global supplier of radiographic solutions.
The transactions underline Sunstone Capital’s position as one of the leading venture capital investors within life science in the Nordic region.

Peter Benson at Sunstone Capital said: “It is an exciting time in the development of the company and Sunstone Capital are committed to supporting management in its development plans. We are delighted to participate in the success of IMIX Holding AB and look forward to taking an active role as the company continues to strengthen its position and expand into new markets and products.”

The interim efficacy data of the clinical trial are expected June 2010. AP214 is being developed for protection of acute kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication. “Completing the dosing ahead of schedule in the phase II clinical trial is a major milestone for Action Pharma”, says Ingelise Saunders, CEO of Action Pharma. She continues, “it also represents an important step forward in our partnering and corporate development strategy.”

Action Pharma A/S has completed a proof of concept clinical phase IB study with AP1030 currently being developed for treatment of type II diabetes associated with obesity. In a phase IB study the effect of AP1030 on glucose metabolism in obese human volunteers was investigated. AP1030 administered orally once-daily for two weeks in obese human volunteers significantly improved glucose metabolism.

Zymenex Holding A/S (Hillerød, Denmark) has today announced that they have acquired all the shares in ACE Biosciences A/S (Odense, Denmark) with the purpose of validating and applying the protein technology of ACE Biosciences A/S on the enzyme-replacement development focus of Zymenex A/S.

Protein technology is the core technology of Zymenex A/S, and the company has decided to expand the area of proprietary protein expertise into the field of proteomics and hence evaluates the ACE Biosciences A/S platform as a perfect fit, whereby the development and commercialization of therapeutic proteins can be strengthened. Zymenex A/S has over the years developed a number of protein-based enzymes for treating specific rare diseases and has been able to move several into proof-of-concept clinical trials. In 2008 Zymenex A/S sold their lead candidate Metazym to Shire Plc for DKK 655 million (USD 135 million).

The ACE Biosciences A/S technology combines and integrates a number of methods that each have an essential function in target discovery and validation leading to a target candidate: state of the art surface protein isolation and identification, sophisticated bioinformatics based screening and selection of candidates, effective development of well characterized recombinant proteins and application of in vivo methods for functional screening of target proteins, which can be selected for pre-clinical and clinical development.

“We see this as a great opportunity for Zymenex to strengthen our project portfolio and to use the new area of Proteomics, to build a second generation product platform, which complements our basic protein knowledge. As history has shown us and for many other biotech companies, drug development is both risky, costly and takes years before success is achieved. A new technology platform can, as has been shown in other companies, give a broader basis for our drug development and spread the inherent risks.” says CEO Jens Fogh of Zymenex A/S.

Concomitantly with the acquisition of ACE Biosciences A/S, Zymenex A/S will – through the ACE Biosciences A/S subsidiary – engage in a license agreement and collaboration with the Danish company TD Vaccines A/S. The license agreement concerns ACE527 (an oral ETEC vaccine) and ACE920 (an ETEC and Campylobacter vaccine). Since this is a core area of TD Vaccines A/S, it is the belief of Zymenex A/S, that these specific assets will progress most efficacious in the hands of TD Vaccines A/S in exchange for compensation to Zymenex A/S. ACE Biosciences A/S and Zymenex A/S are both owned by venture investors BankInvest and Sunstone Capital, who will retain their ownership of the companies going forward.

“Zymenex was up against an external competitive bid for ACE Biosciences in the sales process, but we are proud that the board of directors, the management, and all investors in ACE Biosciences in the end chose Zymenex as the best manager of their assets. From the point of view of the shareholders of Zymenex A/S, this choice not only enhances the long-term strategy in Zymenex of developing a target enzyme generator platform, it also increases the chance of a repetition of profitable exits on the lead program of Zymenex. One example of the strength of the Zymenex organisation is the sale of the Metazym project in 2008, which made a business newspaper rank Zymenex as the 7th most profitable Danish life science company in 2008, but certainly number one when measured as profits per employee.”, says Chairman Thomas Tscherning of Zymenex A/S.

“Patrik joins Chempaq as the company takes a new step forward. The next generation of our hematology instruments is ready for launch, a partnership with Philips has been initiated and additional new partnerships are being negotiated. Patrik brings to Chempaq a strong international diagnostics industry background and insight to the company and I believe that he is uniquely qualified to manage Chempaq through to the next level of commercialization”, says Rabbe Klemets, Chairman of Chempaq A/S.

Evolva raises CHF 28M

Sunstone Capital portfolio company Evolva SA, a Swiss headquartered international biotech company today announced a CHF 28 million first closing of its Series B financing round.

The Series B financing is led by current investor Aravis and new investors Auriga Partners, Vinci Capital – Renaissance PME and Wellington Partners. BioMedInvest and an undisclosed private investor participated as co-investors in the first closing, as well as Evolva’s existing investors Astellas Venture, Dansk Innovation, Novartis Bioventures and Sunstone Capital.

Action Pharma

Action Pharma has initiated a new clinical phase II trial for its leading development candidate AP214, investigating the effect of AP214 on organ protection in patients undergoing cardiac surgery, who are at increased risk of kidney injury. The clinical trial has been launched in Denmark at “Rigshospitalet”.

The Denmark-based life science company Chempaq, leading within Point of Care diagnostics, has signed a technology licensing agreement with Philips regarding its portable Chempaq XDM technology for complete blood count testing.

With the technology licensing agreement of Chempaq’s XDM®, Philips becomes the first company to use the technology for its development of in-vitro diagnostic tests designed for use in home settings.

Sunstone Capital’s portfolio company, Evolva SA (Evolva), plans to merge with Arpida Ltd. (Arpida) that is publicly traded on the Swiss Stock Exchange. A key purpose of the merger is to provide Evolva with first-mover advantages through an early presence on the public market. The planned merger will provide a solid platform for growth for Evolva to ensure financing and support for clinical trials for EV-086, EV-077 and other Evolva compounds that address major unmet medical needs within renal disease and fungal and viral infections. The merged company will have significant annual revenues combined with a strong cash position and new financing.

Zealand Pharma is developing a new treatment for Type 2 Diabetes. ZP2929 has the potential to significantly decrease body weight and reduce the risk of Diabetes-related complications. ZP2929 is a dual Glucagon-GLP-1 agonist, a peptide drug which interacts with two receptor systems that play a role in metabolism and Type 2 Diabetes.
Zealand Pharma’s new drug has the promise of significantly lowering the weight of people with diabetes who are overweight or obese, thereby preventing related illnesses such as cardiovascular disease. The drug is now moving into pre-clinical development.
“We have been through a long and exciting research period. The result is a new dual Glucagon-GLP-1 agonist that both controls the blood glucose levels and reduces weight in obese diabetic models,” says Dr. David H Solomon, CEO of Zealand Pharma. “Having diabetes is hard to manage because you have to control and regulate your blood glucose levels. In addition many people with Type 2 Diabetes find weight control a struggle and these are the people we hope to help,” Solomon says.

Zealand Pharma advances ZP1846 into Phase I clinical trials. ZP1846, a peptide which incorporates Zealand’s proprietary SIP technology, is developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhoea, a debilitating adverse reaction affecting patients undergoing treatment with many
anti-cancer therapies.

Nuevolution is a unique drug discovery company poised to revolutionize drug discovery and development by utilizing its proprietary ChemeticsTM technologies to synthesize and identify hundreds of drug leads to virtually any target in weeks. Nuevolution recently announced a new research partnership with Novartis. Novartis will make use of Nuevolution’s proprietary ChemeticsTM technologies for lead discovery. For Nuevolution, the agreement involves upfront payment, research funding and milestone payments. Further, Nuevolution is entitled to royalties on the commercial sales of approved products. The partnership with Novartis is part of Nuevolution’s strategy to leverage its broadly applicable ChemeticsTM technologies through collaboration with leading pharmaceutical and biotechnology companies. Sunstone Capital originally invested in Nuevolution in 2001. SEB Ventures and Sunstone Capital are the main investors.

Santaris Pharma A/S and Shire plc will engage in a multi-year research program utilizing Santaris Pharma’s proprietary Locked Nucleic Acid (LNA) Drug Platform to identify and select drug candidates against certain targets for the treatment of rare genetic disorders.
Santaris Pharma A/S will receive significant upfront payments, milestone payments and royalties for providing access to its LNA technology, exclusivity for three pre-defined targets and funding for discovery.
Partnership for the treatment of rare genetic disorders further demonstrates versatility of the LNA Drug Platform to develop RNA-based medicines for a range of disease areas including metabolic disorders, cancer, infectious and inflammatory diseases.

IPC International has bought all shares in Sunstone Capital portfolio company NatImmune, which is focused on developing protein-based drugs for treatment of cancer and infections.IPC International is a specialty pharma company in growth. Claus Møller, CEO, is excited about the investment in NatImmune and states: “We believe that NatImmune’s drug, which among other things can be used in treatment of warts, seems very promising and it is a perfect match for our niche strategy. Our goal is to further develop new products and bring them to market within a reasonably short time horizon.”
Peter Benson, Managing Partner at Sunstone Capital, is also very pleased about the deal: “The investors behind NatImmune are very satisfied with the divestment to IPC International.” He trusts that IPC International will be the perfect new home for the further development and future marketing of NatImmune’s products.

Sunstone Capital portfolio company Zealand Pharma A/S participated in a panel presentation at 2009 BIO International Concention along with sanofi-aventis and a Health Care advisor to the Obama administration. The presentation “Innnovating for Diabetes: A Number One Priority” took place on May 18 at the largest global event for the biotechnology industry.
At BIO2009, David Salomon, CEO of Zealand Pharma A/S, spoke on the perspective of a biotech ccompany and explained the importance of co-operation ind the field of diabetes as well as elaborating on the successfull business model of discovering new innovative drugs and partnering with global drug development companies.

Sunstone Capital portfolio company Zealand Pharma A/S has received this year’s prestigious Frost & Sullivan European Research & Development Award.
Zealand Pharma A/S is rewarded for demonstrating technological superiority within its industry. The Award recognizes the ability of the company to succesfully develop and introduce new technology, formulate a well-designed product family, and make significant product performance contributions to the industry.
CEO of Zealand Pharma, David Solomon, is honoured by the recognition. “The European Research & Development Award highlights our company’s ongoing achievements in its path to commercializing peptide-based drugs that treat unmet medical needs in the areas of diabetes, metabolism, cardiovascular disease and gastrointestinal disorders such as Crohn’s Disease”, he says.

Symphogen A/S today announced the closing of a euro 33 million (approximately usd 44 million) financing. Existing investors participated in the round, which was led by Essex Woodlands Health Ventures. The financing will be used to mature the company’s product pipeline of antibody therapeutics, particularly within the field of oncology.
“This significant financial commitment from our current investors demonstrates their confidence in Symphogen’s innovative pipeline and antibody discovery and manufacturing technologies,” said Kirsten Drejer, CEO of Symphogen. “The current funding will support the advancement of our lead oncology program, Sym004, towards early clinical studies as Symphogen continues to build a competitive oncology franchise. Coinciding with our strategic decision to focus our internal R&D resources on further maturing our oncology pipeline, Symphogen also plans to broaden our external collaborative activities by engaging in partnership discussions for our anti-RSV and anti-RhD recombinant polyclonal antibody programs.”

Sunstone Capital portfolio company Action Pharma is happy to announce that Torben Jung Laursen has been appointed Executive Vice President of Business Development.
“Torben Jung Laursen is a very strong executive and brings top international expertise in business development to the executive management of Action Pharma,” says Søren Nielsen, CEO of Action Pharma. “The timing is optimal since Action Pharma has a relatively large pipeline in clinical and preclinical development, which is now ready for commercialization.”
Torben Jung Laursen comes from a position as Vice President for New Products and Technologies at Alpharma and has worked 20 years for companies such as Novo Nordisk and Roche.

The Novo Nordisk Prize was founded by the Novo Nordisk Foundation and is awarded in the Foundation’s name and from the Foundation’s funds. The prize is awarded – without application – in recognition of unique medical research or other research contributions that are of benefit to medical science.
”With his impressive scientific results Søren Nielsen is placed in the international elite with a very comprehensive scientific production published in high impact research journals,” says Professor Jan Fahrenkrug, chairman of the Prize committee at the Novo Nordisk Foundation.“I am deeply honored and very proud of this prestigious award” says Søren Nielsen, CEO. “It gives major attention to our research achievements and to Action Pharma A/S which was founded in 2000 based on part of this research.”

The prize was awarded based on Søren Nielsen’s and his colleagues’ discoveries on the fundamental role of cell membrane water channels (aquaporins) in water balance regulation and that dysregulation of aquaporins play pivotal roles in water balance disorders including acquired and inherited kidney diseases, heart failure and brain edema.

Santaris Pharma and Wyeth Pharmaceuticals, announced January 12th 2009 that the companies have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris Pharma’s proprietary Locked Nucleic Acid (LNA) drug platform.

Santaris Pharma will receive an upfront payment of $7 million in cash and Wyeth will make a $10 million equity investment in Santaris Pharma. Santaris Pharma may receive further milestone payments of up to $83 million for each of 10 potential targets. In addition, Santaris Pharma would receive royalties on the worldwide sales of all products arising from the alliance.

Sunstone Capital portfolio company Zealand Pharma A/S and Helsinn Healthcare SA today announced that it has signed a partnering agreement, for the development and worldwide commercialization of ZP1846, a GLP-2 (glucagon-like peptide-2) receptor agonist which provides a novel way to treat chemotherapy-induced diarrhea (CID), a debilitating condition affecting patients undergoing cancer treatment with a range of chemotherapies.

NatImmune A/S today announced the initiation of a phase IIb clinical trial designed to evaluate the safety and efficacy of its BAMLET Tropical Gel, a protein-lipid based proprietary dermatological product candidate, for the treatment of recalcitrant warts in immuno-suppressed kidney-transplanted patient when applied locally to wart lesions.

Copenhagen, Denmark and Seattle, WA, USA, June 19, 2008—ACE BioSciences and PATH have announced a new partnership to advance the development of a promising vaccine against one of the leading bacterial causes of diarrheal disease, enterotoxigenic E.coli (ETEC). PATH will fund ACE BioSciences to complete Phase 1 and Phase 2 clinical trials up to proof of concept of its ACE527 vaccine. ACE527 offers the broadest coverage among currently available ETEC vaccine formulations, and the vaccine’s components have already been tested in more than 100 subjects.

Sunstone Capital A/S announces the Second Closing of its fundraising that began in 2007. New investors include institutional investors Sampension Private Equity F.M.B.A. and Finnish Industry Investment Ltd, as well as additional private investors, who in total have committed approximately EUR 21 million, increasing total funds under management to EUR 411 million.

Under the terms of the alliance, Nuevolution’s proprietary Chemetics® drug discovery technology will be applied to identify novel small molecule lead compounds against a range of drug targets proposed by Lexicon. Nuevolution will receive an upfront payment and will be eligible for milestone payments and royalties on compounds identified using its technology as candidate molecules progress through preclinical and clinical development and onto the market. At a future point in time, Nuevolution will have the option to expand its involvement in certain programs under a cost and profit sharing arrangement.

Sunstone Capital portfolio company Nuevolution announced in June that it has entered into a drug discovery collaboration with Merck & Co. Inc. Nuevolution will apply its proprietary Chemetics drug discovery technology to identify novel small molecule leads against several drug targets of interest to Merck. Under the terms of the agreement, Merck will provide Nuevolution with an upfront payment, research funding, and milestone payments as candidate molecules progress through preclinical and clinical development and onto the market. In addition, Nuevolution is eligible to receive royalties on the commercial sales of approved products. Further financial details have not been disclosed.

Santaris Pharma A/S, a Danish biopharmaceutical anti-sense/RNAi company, has announced that Søren Tulstrup, previously Vice President, Global Human Health at Merck & Co, Inc, has been appointed President & Chief Executive Officer, effective July 1, 2008. Prior to joining Merck, Søren Tulstrup held management positions with Sandoz AG (now Novartis) in Basel, Switzerland and Abbott Laboratories in Copenhagen, Denmark. He holds a Master of Science degree in Economics and Business Administration from Copenhagen Business School and the JL Kellogg Graduate School of Management, Northwestern University, in Chicago.

PreciSense A/S, headquartered in Horsholm, Denmark, is a diagnostics company focusing on minimally invasive continuous glucose monitoring (CGM) technologies. Specific terms of the acquisition are not disclosed.

By this acquisition Medtronic moves significantly closer to providing a closed-loop system that will more frequently and more precisely monitor the available glucose in diabetes patients and more correctly dose the required amount of insulin. A closed-loop system simulates the insulin delivery of a normal pancreas using a device that intelligently accommodates for glucose fluctuations in insulin-challenged persons via an automated delivery of insulin.

Sunstone Capital LSV Fund I initially invested in PreciSense A/S in 2003 and has actively managed PreciSense together with Georg Skøtt (CEO of PreciSense A/S), Scandinavian Life Science Ventures and Omega Funds. The company will cease its R&D operations in the field of CGM and will onwards focus on supporting the agreement pertaining to the acquisition.

Fierce Biotech has announced that Santaris Pharma has been included in the annual FierceBiotech “Fierce 15” list, designating it as one of the top biotech companies of 2008. The editors of FierceBiotech evaluated hundreds of privately-held firms based on company vision, revenue potential, quality of deals, strength of technology, partnerships, and competitive market position. Santaris Pharma was determined to be one of the “fiercest,” proven by their creativity and innovations in the industry.

Zymenex hosts the EU sponsored Alpha-mannosidosis Hue-Man consortium meeting, which takes place in Denmark during the days of May 9 – 10, 2008. The Hue-Man project group consists of leading scientists and clinicians from prominent universities and hospitals from around Europe, who together with Zymenex, have in 2006, received a 3-year 6th framework EU grant of € 3.2 million. The group is devoting their efforts to investigate and establish clinical parameters in the Alpha-mannosidosis mouse model and to perform a natural history study of the human disease in patients, in order to define clinical endpoints for the upcoming first clinical trials in man.

The Hue-Man project takes and expands the knowledge obtained by the joint research group from the three year 5th framework EU grant supported EURAMAN project, which successfully established an enzyme replacement therapy for a mouse model of Alpha-mannosidosis and demonstrated correction of storage in many tissues including brain, after administration of the lysosomal acid a-mannosidase enzyme (rhLAMAN) Lamazym, developed by Zymenex.

About the disease
The disease is due to a deficiency of the a-mannosidase enzyme and affects approximately 500 patients worldwide. Alpha-mannosidosis is a rare inborn disorder that results in mental retardation, skeletal changes, hearing loss, recurrent infections and progression to early death. The children are often born apparently normal and their conditions worsen progressively, without any possibility to prevent this evolution. In the children that are born healthy, a therapy initiated at an early age could contribute to a normal development. Today, the most promising therapy for lysosomal storage diseases is enzyme replacement therapy (ERT), here the enzyme lacking in the patient is introduced into the blood stream, from where it is internalized by the cells and reaches the lysosomes, acting as the original missing enzyme.

Zymenex has – with the financial support of BankInvest Biomedical Venture and Sunstone Capital – achieved successful early clinical development of a therapeutic candidate Metazym against the rare, lethal and genetically caused, disease MLD, which most often affects children at a very young age. This has now resulted in a sale of the therapeutic project to the global specialty biopharmaceutical company Shire plc.

The FDA has granted Zymenex Orphan Designation for its enzyme Metazym, for the treatment of the rare, lysosomal disease Metachromatic Leukodystropht (MLD).
Orphan designation qualifies the sponsor of the product for tax credits and marketing exclusivity inventives of the Orphan Drug Act.

Zymenex has received FDA approval of its Investigational New Drug (IND) application for its enzyme Metazym, which is intended for use in the treatment of the rare, lysosomal disease Metachromatic Leukodystrophy (MLD). The company is now preparing for Phase 2 clinical trials in the USA.

COPENHAGEN – The investments are key links in Sunstone Capital’s strategy to help strengthen growth potential for established biotech firms in the Oresund Region. Sunstone has done this by contributing its own money as well as by raising capital from local and international investors.

Egalet

Danish biotech company Egalet strengthens management by appointing internationally experienced CFO

Danish specialty pharmaceutical company Egalet has appointed Mr Bertrand Damour as its Chief Financial Officer and Executive Vice President.

Mr Damour has extensive experience in the international financial markets and biotechnology industry and will reinforce Egalet’s position in the global pharmaceutical and biotechnology sector.

Zymenenex

Novel Natural History Study to answer question in Rare Disease

The Natural History Study of the rare lysosomal disease alpha-Mannosidosis will answer the question; why the rare disease develops as it does? The first patients have been included in the first Natural History Study of the disease, being conducted under the HUE-MAN project, a 6th framework, EU grant supported initiative.

Santaris Pharma consortium awarded €1.35m by Denmark’s Advanced Technology Foundation for development of the first microRNA medicine

Santaris Pharma announced today that the Danish National Advanced Technology Foundation (ATF) has awarded a grant of €1.35 million towards the development of the first ever drug targeted against a human microRNA.

The drug candidate, SPC3649, is an antagonist of the liver-specific microRNA-122 and is being developed by Santaris in collaboration with the Centre for Biological Sequence Analyses at the Technical University of Denmark and the Department of Cellular and Molecular Medicine, University of Copenhagen.

New, groundbreaking technology may lead to a new generation of healthy dairy products

Chr. Hansen’s scientists see interesting potential in new, unique fermentation technology which improves conditions for “friendly” gut bacteria.

Yoghurts, soft drinks or juices with many more of the “friendly” gut bacteria (probiotics) with higher longevity and improved health effects – superior fermented dairy products or new developments within functional foods, we can’t even imagine today. These are some of the interesting prospects, Chr. Hansen researchers and technicians are facing with the help from this new technology.

The agreement with Chr. Hansen, a leading manufacturer of food ingredients, demonstrates commercial viability of Jurag Separations unique separation system and confirms the technology’s attractiveness for scalable and productive solutions in industrial settings.

With the joint venture Chr. Hansen gets access to Jurag Separations patented REED filtration technology, which offers advanced electro-membrane solutions for separation of ionic species directly from fermentation broth as well as from a variety of other complex process streams.

Zymenex has initiated the Phase II part of the clinical trial in seriously ill children with MLD.

Zymenex has initiated the Phase II part of the clinical trial in seriously ill children with MLD.

The trial will hopefully show the way to a cure for the rare and until now incurable disease, Metachromatic Leukodystrophy (MLD), which is diagnosed in children between the ages of 2-5 years and paralyses the nervous system in such a way that the children die.

Santaris Pharma presents positive clinical data on SPC2996 in Chronic Lymphocytic Leukaemia.

Santaris Pharma, the Danish biopharmaceutical company, announced today that SPC2996, the Company’s new RNA Antagonist of Bcl-2, has shown early evidence of efficacy in an initial Phase I/II clinical study in Chronic Lymphocytic Leukaemia (CLL). The results of the study were reported this week at the 2007 Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois.

Santaris Pharma har udviklet den første nye lægemiddelkandidat i verden, som er rettet mod MicroRNA. Lægemiddelkandidaten skal nu videreudvikles af et MicroRNA Forskningskonsortium, som bliver støttet af Højteknologifonden med 10 mio. kr.

Det samlede budget for udviklingspro-jektet er 20 mio kr. MicroRNA Forskningskonsortiet består foruden Santaris Pharma af Center for Biologisk Sekvensanalyse (CBS), DTU samt Institut for Cellulær og Molekylær Medicin på Københavns Universitet MicroRNA, der forekommer naturligt i alle celler, er en nyopdaget klasse af små RNA molekyler, som regulerer aktiviteten af andre gener i cellen.

Ace Biosciences

Ace Biosciences in-licences phase I enterotoxigenic E Coli (ETEC) vaccine from Cambridge Biostability Ltd- Deal involves initial payment, milestone and royalties.

ACE BioSciences A/S, the infectious diseases company and Cambridge BioStability Ltd (CBL), the British biotechnology company have entered a strategic deal whereby ACE BioSciences in-licenses CBL’s ‘HolaVax’, (to be called ACE537) an oral Phase I Enterotoxigenic E Coli (ETEC) vaccine which has the potential to be the first to market in the US and EU and which combats the single biggest cause of travelers diarrhoea.

Santaris Pharma, the Danish biopharmaceutical company, announced today that Dr Flemming Ørnskov, Chief Executive Officer of Lifecycle Pharma A/S, has been elected non-executive Chairman of Santaris Pharma A/S.

Dr Ørnskov takes over responsibilities from Santaris Pharma’s current Chairman, Martien van Osch, a general partner at Forbion Capital Partners, with immediate effect. Dr Ørnskov was appointed to the Santaris Pharma Board by shareholders at the Company’s Annual General Meeting on 24th May 2007 and elected Chairman by the Santaris Pharma Board immediately thereafter.

Offering fixed, mobile, internet and in the future IPTV services, the challenge facing this company is the flexibility required to effectively cross and upsell its extensive product portfolio. The complexity of the underlying systems is proving to be a barrier to customer communications.

With Agillic’s SOA architecture it is easily able to integrate with any existing IT system to collate a single view of the customer and thereby create a seamless customer experience. Full digital marketing programmes will then be devised to match the needs of the customer with the right products to create the same high level of loyalty it currently enjoys from its energy customers amongst its telecommunication customers.

Symphogen A/S announced today that it has entered into a global strategic collaboration with Genentech, Inc. for antibody therapeutics against three undisclosed infectious disease targets. In this collaboration, Symphogen will apply its proprietary Symplex™ antibody discovery technology platform to identify novel infectious disease drug candidates. Furthermore, Genentech will gain access to Symphogen’s Sympress™ technology to produce recombinant polyclonal antibodies.