• Affectis Pharmaceuticals AG, of Munich, Germany, signed a collaboration agreement with Tokyo-based Mitsubishi Pharma Corp. to develop therapeutics for affective disorders. Under terms of the agreement, Affectis will apply its target validation technology and exclusive animal models for the validation of Mitsubishi's gene targets involved in depression and anxiety.

• Affitech A/S, of Oslo, Norway, and Viventia Biotech Inc., of Toronto, achieved the first two research milestones in their collaboration, involving Affitech's discovery and selection of several antibodies in a specific cancer area using its Cell Based Antibody Selection technology and Viventia's ImmunoMine antibody-profiling platform. The milestones triggered an undisclosed research payment to Affitech.

• Antisoma plc, of London, completed the acquisition of Aptamera Inc., of Louisville, for £11.5 million (US$21.5 million) in shares. Following the deal, around 30 percent of Antisoma's shares will be held by North American investors. Aptamera's lead product, AGRO100, has been re-designated AS1411, and Antisoma is considering whether to take the product forward to Phase II in a specific cancer or re-open the Phase I trial.

• Ardana Bioscience plc, of Edinburgh, UK, signed a three-year extension to its contract with the UK Medical Research Council's Human Reproductive Sciences Unit (HRSU), giving exclusive rights to commercialize research from the unit. That follows a previous five-year agreement, which expires in July. Ardana will fund specific research projects at the HRSU, in the areas of neuroendocrine regulation of reproduction, cancers of the reproductive tract, and inflammatory and immune mediators in the female reproductive tract.

• Arexis AB, of Gothenburg, Sweden, obtained European Union orphan drug status for recombinant bile sale-stimulated lipase, an enzyme-replacement therapy for treatment of fat malabsorption in cystic fibrosis patients. The product has completed a Phase II trial. Arexis also is seeking orphan designation for the product in the U.S. and is planning dose-finding and Phase III trials.

• Atugen AG, of Berlin, and Asinex Ltd., of Moscow, announced a long-term drug discovery and development collaboration for a protein kinase target during the 3rd annual BioPartnering North America conference in Vancouver, British Columbia. Atugen said it will contribute work in target discovery and in vivo screening, while Asinex will handle drug design, medicinal chemistry and in vitro screening, with the goal of finding cancer compounds. The collaboration will be performed on a shared-risk basis, and future revenues will be equally divided between the companies.

• Benitec Ltd., of Queensland, Australia, signed an exclusive license agreement with the Garvan Institute of Medical Research in Sydney, Australia, to use Garvan's Hot Mouse technology, which features a genetically modified mouse that lacks the c-Cbl gene. Benitec has rights to develop RNA interference-based drugs for diabetes, obesity and related disorders. The companies also entered discussions for a research collaboration to develop those therapies.

• Biosystems International, of Evry, France, raised €3 million (US$3.8 million) in an initial financing round from two funds managed by Société Générale Asset Management, the venture capital subsidiary of the Paris-based bank Société Générale. The company was founded in May and is focused on new biomarkers compatible with the constraints of clinical development protocols for the development of therapeutics and diagnostic tests.

• Biota Holdings Ltd., of Melbourne, Australia, and GlaxoSmithKline plc, of London, have been ordered to take their dispute into mediation by a Supreme Court judge in Melbourne. Biota is suing Glaxo for an unspecified amount over the failure of a flu cure using its technology, which was made and marketed by Glaxo. The parties are not required to reach an agreement in mediation.

• BioTie Therapies Corp., of Turku, Finland, and Tripos Inc., of St. Louis, entered a partnership to enhance BioTie's drug discovery efforts, which include medicines for the treatment of dependence disorders, inflammatory diseases and thrombosis. Tripos will identify and optimize backup series for one of BioTie's key drug discovery programs. Tripos then will create compound libraries for in-house screening by BioTie.

• Cavis Microcaps GmbH, of Mainz, Germany, raised €5 million (US$6.4 million) in Series A financing. The company has a technology to make small capsules that prevents sensitive substances, such as yeasts, vitamins or enzymes, from degradation, and it is targeting it for the food and animal feed industries. Inventages Venture Capital Investment Inc. committed €3 million, making it the largest investor in the round. The remaining €2 million in the round came from BASF Venture Capital GmbH.

• ComGenex Inc., of Budapest, Hungary, finalized an agreement with Echelon Biosciences Inc., a subsidiary of AEterna Zentaris Inc., to transfer to Echelon all rights to develop, manufacture and market certain P13K inhibitors that were created under their joint drug discovery program. ComGenex applied its chemo-informatics technologies, ADME applications and medicinal chemistry to create the drug candidates.

• Dr. Reddy's Laboratories, of Hyderabad, India, initiated Phase I trials of its cardiovascular drug candidate RUS 3108. The trials are being conducted in Belfast, Ireland, and will explore the safety and pharmacokinetic profile of the candidate in humans. It is the first time the company is testing a drug in Europe. RUS 3108 is being developed for the treatment of atherosclerosis.

• Eirx Therapeutics plc, of Cork, Ireland, entered a three-month research project with Merck & Co. Inc., of Whitehouse Station, N.J., during which it will demonstrate to Merck its siRNA delivery technology. Eirx has developed the method for validating novel, apoptosis-associated cancer drug targets.

• ExonHit Therapeutics SA, of Paris, and Agilent Technologies Inc., of Palo Alto, Calif., reported the launch of ExonHit's SpliceArray Service, which uses a new generation of microarrays developed with Agilent to detect alternative splicing in potential drug targets.

• GPC Biotech AG, of Martinsried, Germany, started a Phase I trial for a cancer monoclonal antibody called 1D09C3. The antibody is GPC's first internally developed cancer compound to enter human clinical testing. It is being evaluated in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy.

• Helsinn Healthcare SA, of Lugano, Switzerland, and ribosepharm GmbH, of Munich, Germany, signed an agreement granting ribosepharm the exclusive license and distribution rights for Aloxi (palonosetron hydrochloride) in Germany. Aloxi is the second generation of 5-HT3 antagonists, the leading class for the prevention of nausea and vomiting induced by chemotherapy.

• Institut Curie, of Paris, and Affymetrix Inc., of Santa Clara, Calif., formed an alliance that will use GeneChip microarray technology in large-scale clinical studies to produce genetic signatures for different types of cancer and be used to develop diagnostic tests. Institut Curie will conduct the studies from its translational medicine division. The first two projects will focus on identifying genetic markers for cancer prognosis.

• Kiadis BV, of Groningen, the Netherlands, completed its €4 million (US$5.2 million) Series B financing round. The company said proceeds will help accelerate its screening programs for drug discovery and support its focus on kinases as one of the main target classes for discovery and optimization programs. Kiadis' technology platform, BioSelect, features pharmaceutical targets for partnerships and in-house discovery programs.

• MediBIC Inc., of Tokyo, and NuGEN Technologies Inc., of San Carlos, Calif., agreed to a sales and technical services partnership that includes MediBIC's genomic technology marketing to support the adoption of NuGEN's Ovation family of RNA-amplification systems in Asia. Financial terms were not disclosed. NuGEN also announced the opening of its European sales office to directly service customers performing gene-expression analysis experiments.

• Micromet AG, of Munich, Germany, reported additional preclinical data on its drug candidate MT201, an antibody being developed to treat prostate and breast cancer. The results showed the elimination of various human breast cancer cell lines. The compound is being co-developed with Serono and is in Phase II trials for both indications.

• MorphoSys AG, of Martinsried, Germany, said that GPC Biotech AG, also of Martinsried, began a Phase I trial with a fully human cancer antibody generated using the MorphoSys HuCAL technology. It is the first MorphoSys-generated antibody to be administered to humans, the company said. The commencement of clinical trials triggers an undisclosed clinical milestone payment from GPC Biotech to MorphoSys.

• Mutabilis SA, of Paris, opened a medicinal chemistry department at the company's new facility in Biocitech, the technology park recently created in Romainsville, near Paris. The new location now is the company headquarters. Mutabilis is focused on antibacterial drug discovery.

• Norwood Abbey Ltd., of Melbourne, Australia, said that its investigational new drug application, which was filed in December, was accepted by the FDA. The IND relates to the beginning of the company's first autologous bone marrow transplant trial in the U.S. with partner TAP Pharmaceutical Products Inc., of Lake Forrest, Ill. The key endpoints in the trial will be the determination of immune responses to four vaccines as an indicator of improved immune function in patients undergoing an autologous BMT. It is expected that the trial will begin within the next three months.

• Norwood Immunology Ltd., of London, said its investigational new drug application for a Phase II study of gonadatrophin-releasing hormone (GnRH) in rebooting the immune system following bone marrow transplantation received FDA approval. Norwood has evidence that GnRH encourages the growth of the thymus, leading to increased production of immune-stimulating T cells.

• Optimata Ltd., of Ramat Gan, Israel, and the Soroka University Medical Center reported the launch of a validation study for the treatment of breast cancer using Optimata's Virtual Cancer Patient technology. The technology creates an in silico clone for each patient and predicts how the patient would respond to leading cancer drugs.

• Oxford BioMedica plc, of Oxford, terminated the merger talks that were disclosed on Jan. 19. The company's stock price fell 5 pence to 19.5 pence on 5.3 million shares traded when the news was announced Monday. Also, Oxford BioMedica announced also a further license agreement for its LentiVector gene delivery technology, with an undisclosed biopharmaceutical company.

• Pepscan Systems BV, of Lelystad, the Netherlands; Proteomika SL, of Derio, Spain; and AlgoNomics NV, of Ghent, Belgium, obtained research funding with the 6th framework scientific program of the EU together with the University Medical Centre in Utrecht, the Netherlands; the National Cancer Research Centre in Madrid; and the University Louis Pasteur in Strasbourg, France. The project was initiated by Pepscan and is sponsored by the European Union with a research grant of €1.2 million (US$1.6 million). The grant will be used to develop fully synthetic antibodies to treat pancreatic cancer.

• PharmaDesign Inc., of Tokyo, announced that its representative Summit Pharmaceuticals International, also of Tokyo, licensed PharmaDesign's GPCR Peptide Ligand Library to Whitehouse Station, N.J.-based Merck & Co. Inc. Financial terms were not disclosed. PharmaDesign is a genomic drug discovery company that uses bioinformatics and silico protein science.

• Protemix Corp., of Auckland, New Zealand, is opening an office in San Diego, where Larry Ellingson will serve as new CEO. Ellingson is a former Eli Lilly and Co. executive and current chairman of the American Diabetes Association. He will focus on extending and developing Protemix's commercial relationships, in particular, to progress Laszarin, its lead compound, through Phase III trials in heart failure in people with diabetes. He also will be responsible for developing the corporate team covering regulatory affairs, clinical trials and business development.

• Sanofi-Aventis Group, of Paris, received marketing approval from the FDA for a new aqueous solution formulation of Eloxatin (oxaliplatin injection). The formulation is a clear, preservative-free, colorless solution, which does not require reconstitution prior to dilution and administration. Debiopharm SA, of Lausanne, Switzerland, and Sanofi-Aventis share development costs for improvements to the available formulations of Eloxatin, new indications and new methods of use for Eloxatin.

• Serono International SA, of Geneva, reported a 17 percent increase in annual product sales - about $2.2 billion - in the company's fourth-quarter and full-year report. Fourth-quarter sales grew 16.4 percent to $604 million. Of its marketed products, the company reported the largest sales increase for the multiple sclerosis drug Rebif, which brought in about $1.1 billion in 2004, a 33.1 percent increase from the previous year. Serono said its 2005 outlook for product sales is an increase of 10 percent to 15 percent, with estimated total revenues at $2.6 billion and net income between $520 million and $540 million.

• SkyePharma plc, of London, extended an agreement with First Horizon Pharmaceutical Corp., of Alpharetta, Ga., for SkyePharma's formulation of fenofibrate, which is under review by the FDA. The amended agreement now permits First Horizon to launch the product in the first half of 2005. SkyePharma and First Horizon originally signed the agreement in May.

• Speedel Group, of Basel, Switzerland, completed the first human microdosing studies of its new renin inhibitors, SPP630 and SPP635, for hypertension and protecting end organs such as the heart and kidneys. The compounds are the first to be invented by Speedel Experimenta, the company's late-stage research unit, which was established in 2002.

• Stem Cell Sciences Ltd., of Edinburgh, Scotland, received a £1.2 million (US$2.3 million) from the DTI Technology Program to fund a consortium including stem cell experts in industry and academia. The program is aimed at developing high-throughput cell screening to speed the discovery of drug-based regenerative medicines using embryonic stem cells.

• Tepnel Life Sciences plc, of Manchester, UK, said its subsidiary, Diaclone Research, signed a research collaboration with Boehringer Ingelheim, of Ingelheim, Germany. Diaclone will generate murine monoclonal antibodies that recognize human immune regulatory cells, which Boehringer will evaluate as research tools and possible therapies.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and its marketing partner, Savient Pharmaceuticals Inc., of East Brunswick, N.J., agreed to a partial settlement of their disputes with Novo Nordisk A/S, of Bagsvaerd, Denmark, over human growth hormone intellectual property. The three parties have granted each other cross-licenses to any patents covering the hGH active ingredient. An appeal of a district court judgment regarding one portion of the dispute will continue, as will an interference proceeding in the U.S. Patent and Trademark Office. Teva and Savient have dropped their claims for attorneys' fees and damages for wrongful injunction.

• TopoTarget A/S, of Copenhagen, Denmark, and CuraGen Corp., of New Haven, Conn., initiated patient dosing in a Phase II trial evaluating PXD101, a small-molecule histone deacetylase inhibitor, as a potential treatment for advanced multiple myeloma. That initiation triggered an undisclosed milestone payment to be made to TopoTarget. The open-label, multicenter study is expected to be completed by mid-2006.

• York Pharma plc, of York, UK, agreed to acquire Molecular SkinCare Ltd., of Sheffield, UK, in an all-share deal valued at £5.5 million (US$10.3 million). Molecular SkinCare, a spinout from Sheffield University, is developing treatments for eczema and psoriasis.

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