• Amarin Corp. plc, of London, reported positive data analysis from two exploratory Phase IIa studies using Miraxion to treat depression. In a recent exploratory Phase II study, Miraxion was used as monotherapy in 77 patients with a new episode of depression in a six-week trial. It was specified that the presence of specific depression symptomology (patients with melancholic, vegetative symptoms) at the time of entry to the study would predict response. Amarin filed a patent covering the associated intellectual property in late 2004 and intends to publish full results from the trial later this year.
• Antisense Therapeutics Ltd., of Melbourne, Australia, said its American depository receipt program has been declared effective by the SEC. The Bank of New York was appointed as the depository bank for the ADR program, which facilitates the purchase of Antisense shares by U.S. investors. The company's lead compound, ATL1102, is in a Phase IIa study in multiple sclerosis.
• Ark Therapeutics plc, of London, said it will submit an application for marketing approval on a named-patient basis for Cerepro, its gene-delivered therapy for glioma, during the first half of 2005, and also is on track to begin a Phase III confirmatory study in the same time frame. That follows receipt of a Good Manufacturing Practice certification for Ark's gene-therapy production facility in Finland.
• BioLineRx Ltd., of Jerusalem, signed in-license agreements to develop and commercialize three therapeutic candidates. The company signed exclusive agreements with Rimonyx Pharmaceuticals Ltd., of Nes Ziona, Israel, for developing BL-1030, a small molecule for the treatment of inflammatory bowel disease; with Yissum, a technology transfer company of the Hebrew University in Jerusalem, for BL-1050, an HIV therapeutic; and with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University, and Bar Ilan & Development Company Ltd., the technology transfer officer of Bar Ilan University, for development of BL-2010 for resistant cancer.
• BioMena SA, of Tunis, Tunisia, is a new company that has resulted from a technology alliance between Tunisia and Canada. With a $48 million initial investment by North African and European banks and private investors from Tunisia and surrounding regions, the company has a mission to manufacture affordable biopharmaceutical products to treat diseases such as anemia, cancer, hepatitis and multiple sclerosis. BioMena is an exclusive licensee of Montreal-based Prometic Life Sciences Inc.'s Mimetic Ligand technology.
• CMC Biopharmaceuticals A/S, of Copenhagen, Denmark, raised €14 million in a funding round led by Innoven Partenaires, of Paris. CatPen joined as a new investor, while existing investors BankInvest and European Equity also participated. CMC plans to use the cash to support its expansion into the European and North American markets and to add supply of in-market biopharmaceuticals to its services.
• ComGenex Inc., of Budapest, Hungary, completed an agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in high-throughput medicinal chemistry. Roche used ComGenex platform technologies to support internal lead generation for drug discovery and development programs. ComGenex used in silico tools to expedite the design of targeted compound libraries and also synthesized and purified the compounds using its high-throughput synthesis and purification platforms for biological evaluation at Roche. Financial terms were not disclosed.
• Crucell NV, of Leiden, the Netherlands, said it was accepted as a member of the influenza vaccine supply international task force. The task force was created in February 2002 to assist business leaders in ensuring adequate flu vaccine production. Crucell is focused on developing vaccines and antibodies that prevent and treat infectious diseases.
• DeCode Genetics Inc., of Reykjavik, Iceland, submitted an investigational new drug application to the FDA for DG041, a first-in-class, orally administered small molecule for the treatment of peripheral arterial occlusive disease. In preclinical studies, DG041 has been shown to be an antagonist of the EP3 receptor for prostaglandin E2, inhibiting, in a dose-dependent manner, human platelet aggregation induced in vitro by PGE2.
• Researchers from Hadassah University Hospital and Medical Center in Jerusalem and Volcani Institute for Agricultural Research in Bet Dagan, Israel, demonstrated that a frozen and thawed whole ovary removed from a sheep could be used for in vitro fertilization. Results were published in the Journal of Fertility and Sterility.
• Helsinn Healthcare SA, of Lugano, Switzerland, and PT Kalbe Farma Tbk, of Jakarta, Indonesia, signed an agreement granting Kalbe the exclusive license and distribution rights for Aloxi (palonosetron hydrochloride) in Indonesia. Aloxi is a new generation of 5-HT3 antagonists, with activity for the prevention of nausea and vomiting induced by chemotherapy.
• Intercell AG, of Vienna, Austria, appointed Emilio Emini and James Sulat to the company's supervisory board. Emini is currently chief of vaccine development at the International AIDS Vaccine Initiative. Sulat previously worked as chief financial officer of Chiron Corp., and held the same position with Stanford Health Services. Intercell has a vaccine for Japanese encephalitis in Phase III trials.
• Juvantia Pharma Oy, of Turku, Finland, entered a research agreement with Alcon Research Ltd., of Fort Worth, Texas, under which the companies will develop treatments for ophthalmic disorders and diseases. The agreement will provide Alcon with access to Juvantia's collection of compounds and gives Alcon an option to enter a development and license agreement.
• LifeCycle Pharma A/S, of H rsholm, Denmark, plans to file next month for market registration of its modified version of the lipid-lowering drug fenofibrate, LCP-Feno, which can be taken without a meal and still be absorbed optimally in the body. The company aims to complete development of a 160-mg and a 145-mg tablet, each using its MeltDose technology.
• Microsens Biotechnologies Ltd., of London, said its Seprion technology for detecting abnormal prion proteins received European approval for postmortem testing of cattle. Seprion is used in HerdChek, a bovine spongiform encephalopathy test developed by Idexx Laboratories Inc., of Westbrook, Maine, which licensed Seprion in November 2003. Microsens said the approval provides a springboard for developing a test for screening blood donations for the human form of BSE, variant Creutzfeldt-Jakob disease. Seprion can be used to diagnose other diseases in which protein aggregation occurs.
• Ministry of Science, Technology and Innovation in Denmark and the Greater Copenhagen Authority issued a call for tenders to construct and operate a biotechnology science park in Copenhagen. The park will be adjacent to existing research facilities, including the Biotechnology Research and Innovation Center and the Institute of Molecular Biology at the University of Copenhagen, and the Bartholin Institute and the Finsen Laboratory of Copenhagen Hospital Corp. The call closes on June 6.
• Narhex Life Sciences, of Sydney, Australia, will partner with the U.S. National Institute of Allergy and Infectious Diseases to evaluate its protease inhibitor Nar DG 35 Prodrug aimed at hepatitis C and severe acute respiratory syndrome. The company said Phase I trials in Australia and early Phase II trials in Brazil show reductions of viral loads, improvement in immune cell markers and a lack of toxicity.
• NeoMed Management, of Oslo, Norway, raised €38 million in the first closing of its NeoMed Innovation IV Fund, which has a €100 million target. NeoMed, which also has offices in Geneva and New York, acts as a lead investor in deals in Scandinavia and Switzerland, and as co-investor elsewhere.
• Newron Pharmaceuticals SpA, of Milan, Italy, said treatment with its investigational new drug, safinamide, resulted in a significant improvement in all efficacy parameters studied when it was administered to patients with restless legs syndrome. It was well tolerated and did not exhibit any clinically relevant side effects, the company said.
• Nucleonics Inc., of Horsham, Pa., filed with the European Patent Office prior art citations it said are relevant to consideration of a patent application filed by Benitec Ltd., of Queensland, Australia, titled "Control of Gene Expression." Nucleonics said the pending claims are unclear and are invalid as they lack novelty and/or did not involve an inventive step at the time of filing. The company previously filed with the commissioner of patents in Australia requesting re-examination of patents filed by Benitec and the Commonwealth Scientific and Industrial Research Organization, as well as with the U.S. Patent and Trademark Office on another patent.
• Pharmexa A/S, of H rsholm, Denmark, licensed a vaccine adjuvant, QS-21, from Antigenics Inc., of New York, for use in its HER-2 Protein AutoVac therapeutic vaccine, which is undergoing a Phase II trial in metastatic breast cancer patients. Financial terms were not disclosed.
• Pontifax, an investment fund owned by Jerusalem-based Teva Pharmaceuticals Ltd. Chairman Eli Hurvitz, signed a deal to invest $1.3 million in Protalix Biotherapeutics Ltd. (formerly Metabogal) in Karmiel, Israel. In late 2004, Protalix raised $3.5 million, at an estimated company value of $30 million. Today, the start-up, which is developing treatments for Gaucher's disease, is valued at $40 million. Hurvitz will be chairman of Protalix's board, replacing David Haselkorn. Protalix has developed a plant-cell culture-based platform and a bioreactor systems for the large scale production of complex proteins and secondary metabolites.
• Protherics plc, of Runcorn, UK, said the FDA approved a second contractor, Chesapeake Biological Laboratories Inc. (CBL), of Baltimore, to fill, freeze dry and package CroFab, Protherics' polyclonal antibody for the treatment of rattlesnake bites. Protherics also has submitted an application to the FDA for CBL to process DigiFab, for treating overdoses of the heart drug Digoxin.
• Rottapharm SpA, of Milan, Italy, and Xytis Pharmaceuticals Ltd., of London, entered an agreement involving the former company's preclinical compound, neboglamine (CR2249), a potential new treatment for schizophrenia and other central nervous system disorders. Xytis has obtained an exclusive license to develop and market the compound in the U.S., Canada, Japan, Australia and New Zealand. Rottapharm retains rights for all other territories. Terms were not disclosed.
• Serono SA, of Geneva, and Ivax Corp., of Miami, plan to initiate a Phase III study with Mylinax (cladribine) this quarter. The multicenter, multinational study will assess the effectiveness of Mylinax in patients with relapsing forms of multiple sclerosis. The two-year, double-blind, placebo-controlled study will involve more than 1,200 patients.
• Scancell Ltd., of Nottingham, UK, said Biovation Ltd., of Aberdeen, UK, will apply its DeImmunisation technology to two further monoclonal antibodies in Scancell's portfolio. The technology identifies and removes T-cell epitopes from an antibody, reducing its immunogenicity, while retaining the biological properties of the original molecule. The deal covers SC101, Scancell's cancer antibody against Lewisy/b.
• Sinovac Biotech Ltd., of Beijing, received approval for the marketing and sales of its combined hepatitis A and B vaccine, Bilive, by the Chinese drug regulatory body. The Bilive production license has been issued by the SFDA and sales of the vaccine will begin in China shortly, the company said.
• Starpharma Holdings Ltd., of Melbourne, Australia, established a Level 1 American depository receipts program, allowing investors to purchase Starpharma ADRs on the U.S. Over-the-Counter Bulletin Board. Each ADR will equal 10 ordinary shares, as traded on the Australian Stock Exchange.