• 4SC AG, of Martinsried, Germany, received funding as part of the BioChancePLUS support program from the Federal Ministry of Education and Research for development of new drug candidates. The two-and-a-half year, €2.9 million (US$3.7 million) project will aim to develop new chemotherapeutic drug candidates to treat autoimmune diseases, particularly multiple sclerosis.

• Abingworth Management Ltd., of London, opened a new office in Waltham, Mass., which will be run by Michael Bigham. The office will enable Abingworth to focus on East Coast deals in the U.S. The life sciences venture capital group also appointed Roy Lobb as adviser to evaluate new opportunities and assist portfolio companies on the East Coast.

• Acambis plc, of Cambridge, UK, acquired a Rockville, Md.-based fill/finish facility from BioReliance Corp., a subsidiary of Invitrogen Corp., of Carlsbad, Calif. Acambis intends to develop a commercial-scale fill/finish capability for many of its pipeline vaccines, including ACAM2000 and MVA3000 smallpox vaccines, and its vaccines for West Nile virus and other infections. Acambis will pay $3 million up-front and $4.5 million in 12 equal installments between 2006 and 2017 for the facility, and it will assume a 12-year lease. Separately, Acambis said Phase I data of its ChimeriVax West Nile vaccine showed that 96 percent of subjects in the high-dose group and 100 percent in the low-dose group developed West Nile-neutralizing antibodies 28 days after vaccination. The trial enrolled 80 subjects. The results were presented at the 8th Annual Conference on Vaccine Research in Baltimore.

• Allergy Therapeutics plc, of Worthing, UK, received approval from Health Canada for a pivotal trial of its ragweed allergy vaccine. If successful the study would allow the submission for registration in the first half of 2006.

• Alliance Pharmaceutical Corp., of San Diego, said its PFC Therapeutics LLC subsidiary and Beijing Double-Crane Pharmaceutical Co. Ltd., of Beijing, entered a development, license and supply agreement for Oxygent, an intravascular oxygen therapeutic, in the Peoples' Republic of China. Double-Crane, which will make undisclosed up-front, milestone and royalty payments to Alliance, will conduct clinical trials in China. Alliance will have the right to use any resulting data in other countries. Double-Crane will have the option to manufacture Oxygent in China, after approval, and also will have a right of first refusal to add specific additional countries to the agreement upon further negotiation with Alliance. Specific financial terms were not disclosed.

• Antisoma plc, of London, treated the first patient in the Phase II trial of AS 1404, as it released Phase I data on the product, a vascular disrupting agent designed to destroy existing tumor blood vessels. The Phase I identified a suitable dose of AS 1404. The company presented data on AS 1411, an anti-nucleolin aptamer drug in 17 patients with advanced cancers that were unresponsive to therapy also. Seven patients showed stable disease for two months or more, and one had a near-complete response. Of three patients with renal-cell carcinoma, one had stable disease for nine months, a second is stable more than 10 months after receiving the drug, and a third has a near complete response after 10 months. Antisoma plans to reopen the Phase I trial, recruiting patients with renal and non-small-cell lung cancers.

• Atugen AG, of Berlin, has achieved nine milestones in its target validation research contract with Schering AG, also of Berlin. Atugen validated nine cancer drug targets out of several dozen identified by Schering since 2002. Atugen has received milestone payments, annual license fees and research funding, although the companies did not disclose the size of the payments.

• Benitec Ltd., of St. Lucia, Australia, identified a clinical candidate for its RNA interference-based therapeutic against the hepatitis C virus. Benitec also reported the beginning of efficacy and safety studies of its clinical candidate in small animal models, including marmosets. The company said it is on track to begin Phase I trials to treat HCV in the second half of 2006.

• The Biosystems Informatics Institute, of Newcastle-upon-Tyne, UK, formed a trading arm, Turbinia Ltd., to commercialize its bioinformatics and systems biology software tools for use in drug development. Turbinia also secured exclusive rights to distribute systems biology products and services developed at Moscow State University and a number of other Russian institutes.

• Cambridge Biostability Ltd., of Cambridge, UK, plans to develop a temperature-stable vaccine against diarrhea caused by entertoxigenic E. coli (ETEC), for use in developing countries. The product will be based on HoloVax-ETEC, a Phase I product in-licensed from London-based Acambis plc. Michael Darsley, who has directed the HoloVax-ETEC program since its inception, has moved from Acambis to become director of vaccine development at CBL. The company will seek grants from the World Health Organization to develop the product. Acambis retains the right to an exclusive license to serve the North American travelers' vaccine market.

• Co.don AG, of Berlin, began sales of its autologous, 3-dimensional cartilage transplants for treatment of arthritic joints. The application is being undertaken together with Zurich Sport Clinic. Co.don estimated the market for its product at "several hundred million dollars" annually in Europe. The company is recovering from near-bankruptcy in 2003.

• Codexis Inc., of Redwood City, Calif., and Shasun Chemicals and Drugs Ltd., India, of Chennai, India, signed a manufacturing and supply agreement for a pharmaceutical intermediate of a generic drug. The process was developed using Codexis' biocatalytic technology platform. Shasun will manufacture the pharmaceutical compound and Codexis will market the product worldwide to the generic pharmaceutical industry. Financial terms were not disclosed.

• Compugen Ltd., of Tel Aviv, Israel, appointed Alex Kotzer president and CEO effective Sept. 1, after his relocation to Israel. Kotzer most recently served as vice president at Serono. He will replace the current president and CEO, Mor Amitai, who announced in October that he intended to resign before the end of 2005. Compugen is a drug and diagnostic discovery company.

• Corautus Genetics Inc., of Atlanta, and Boehringer Ingelheim Austria GmbH, of Vienna, Austria, said they have entered a long-term manufacturing agreement to produce vascular endothelial growth factor-2 plasmid DNA for a Phase III trial and future commercial use to treat cardiovascular disease (severe angina) and other indications. A Phase IIb trial is ongoing by Corautus. Boehringer began feasibility and GMP activities several months ago.

• Cyclacel Group plc, of Dundee, UK, reported interim data from the European Phase IIa trial of its lead product seliciclib in combination with chemotherapy in advanced non-small-cell lung cancer. Of 14 evaluable patients, six had a partial response, seven stable disease and one progressive disease. There was no increase in side effects from the combination of seliciclib, an orally available cyclin-dependent kinase inhibitor, with chemotherapeutics. The company also reported Phase I data on CYC682, an orally available nucleoside analogue, in 18 patients with advanced solid tumors. The best response to treatment was stable disease in six patients.

• Cytos Biotechnology AG, of Zurich, Switzerland, began a Phase I/II trial of its Immunodrug candidate CYT009-GhrQb, a therapeutic vaccine for obesity. The study will include 112 obese individuals with a body mass index between 30 and 35, and is designed to evaluate the vaccine's safety, tolerability and exploratory efficacy. The treatment period will last six months, during which all participants will receive counseling to change eating habits and improve physical activity, and will be followed for six more months of safety and efficacy monitoring. Efficacy will be determined by measurements of body weight, and initial results are expected in the second half of next year.

• Debiopharm SA, of Lausanne, Switzerland, said a new marketing and supply agreement was formed between Montreal-based Paladin Labs Inc. and Watson Pharma Inc., a subsidiary of Corona, Calif.-based Watson Pharmaceuticals Inc., to market Trelstar 3.75 mg and Trelstar LA 11.25 mg (triptorelin pamoate for injectable suspension) in Canada. Debiopharm developed both products and was responsible for submitting the registration file to the FDA and to Health Canada. Trelstar 3.75 mg and Trelstar LA 11.25 mg, respectively, are one- and three-month sustained-release, injectable formulations of luteinizing hormone-releasing hormone agonists.

• DeCode Genetics Inc., of Reykjavik, Iceland, published an article by a team of its scientists on the results of Phase II studies of DG031, being developed in myocardial infarction. The results demonstrate that DG031 works to correct a biological perturbation caused by genetic risk factors for heart attack the company has identified, and lowers levels of biomarkers for risk of heart attack. The article is titled "Effects of a 5-lipoxygenase-activating protein inhibitor on biomarkers associated with risk of myocardial infarction: a randomized trial," and appears in the May 12, 2005, issue of the Journal of the American Medical Association.

• Dimerix Bioscience Pty. Ltd., an investee company of Starpharma Holdings Ltd., of Melbourne, Australia, secured a grant of A$200,000 (US$155,000) from AusIndustry to support the development of a new class of drugs targeting G protein-coupled receptors (GPCRs). Starpharma, the largest shareholder in Dimerix with a 30 percent stake, also entered a joint venture with Dimerix focused on dendrimer-based GPCR drug discovery and development. The agreement uses Dimerix's Collision technology.

• Epigenomics AG, of Berlin, reported positive results correlating its DNA methylation markers with disease recurrence and prediction of therapy response in early breast cancer. About half of estrogen-dependent, node-negative breast cancer patients have as good a prognosis after 10 years with endocrine therapy alone as they do with a combination of endocrine therapy and chemotherapy. Epigenomics' markers, particularly one designated PITX2, help to identify that group of patients.

• EpiTan Ltd., of Melbourne, Australia, postponed plans to raise up to £15 million (US$27.6 million) in a listing on the Alternative Investment Market in London, blaming market conditions in the UK and Australia. The money was to have funded development and registration of Melanotan, designed to protect the skin against ultraviolet radiation.

• ExonHit Therapeutics SA, of Paris, and Allergan Inc., of Irvine, Calif., extended their collaboration, with ExonHit receiving an additional payment of $2 million from Allergan. The companies originally signed their agreement for a three-year period in December 2002. It covered three therapeutic fields - neurodegenerative diseases, neuropathic pain and ophthalmology - and the new agreement provides for the partners to continue the discovery and development of new therapeutics in those areas. The most advanced compound thus far is finalizing preclinical development. That product is an orally active, small-molecule drug for neuropathic pain synthesized to modulate a pathway identified in tissues taken from Allergan's disease models. ExonHit delivered the drug to Allergan last December, triggering an initial milestone payment. In the collaboration, ExonHit will identify new molecular targets from various libraries, as well as tissue samples and model systems, using its proprietary DATAS (Differential Analysis of Transcripts with Alternative Splicing) technology. The companies may jointly develop novel compounds and commercial products based on the targets, co-owning the products taken into development. ExonHit will retain intellectual property rights to all compounds not developed, and also retains co-development and co-commercialization options in therapeutic areas outside Allergan's specialist areas. ExonHit receives research and development funding, in addition to possible milestones and royalties.

• Galapagos NV, of Mechelen, Belgium, and Asinex Ltd., of Moscow, initiated a drug discovery collaboration in bone and joint diseases. The collaboration will result in a set of optimized leads for Galapagos' validated bone and joint disease drug targets. Financial details were not disclosed.

• GBS Venture Partners, of Melbourne, Australia, closed its GBS BioVentures III Fund, with $145 million, well over its $120 million target size. The venture capital firm is looking for new life science investments and could invest more than $10 million in each company. The fund will provide investments at the seed, start-up or early expansion stage of companies focused on human therapeutics, diagnostics, medical devices and health information technology.

• Genizon BioSciences Inc., of Montreal, acquired the majority of the assets and staff of Sweden-based Global Genomics AB. Genizon has gained access to a novel sequencing technology, five related patents or patent applications and proprietary algorithms for data analysis. The company also is acquiring laboratory and computer equipment and cash. Terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, reported additional data from the HuMax-EGFr Phase I/II study in refractory head and neck cancer at the 2005 American Society of Clinical Oncology annual meeting. Assessed by FDG-PET, seven of 18 evaluable patients achieved partial metabolic response and four had stable metabolic disease one week after their fifth and last infusion. Assessed by CT scan, two of 19 evaluable patients achieved partial response, and nine patients had stable disease. Also, Genmab said its new HuMax-CD38 was effective in killing primary multiple myeloma tumor cells and a range of tumor cell lines by triggering two immune system-killing mechanisms: antibody-dependent cellular cytotoxicity and complement dependent cytotoxicity.

• GW Pharmaceuticals plc, of Salisbury, UK, amended its marketing agreement with Bayer Healthcare AG for Sativex in the UK and Canada. The changes are a consequence of the recent approval of the cannabis-derived spray in Canada before the UK and not vice versa, as was envisaged at the time the marketing deal was agreed to in March 2003. Bayer will make an immediate payment of £1 million (US$1.8 million) in recognition of the Canadian approval, and on UK approval will pay a further £10 million as a milestone payment, rather than subscribing for GW shares.

• Immuno-Designed Molecules SA, of Paris, reported positive results from a Phase III trial of its liposomal muramyl tripeptide phosphatidyl ethanolamine product, called Mepact, which is being developed for osteosarcoma. Mepact is an immune system stimulant designed to promote the destruction of cancer cells by activating macrophages. The trial, conducted over a six-year period on 793 patients with newly diagnosed high-grade osteosarcoma, showed that Mepact added to chemotherapy provided a significant improvement in disease-free and overall survival in patients with non-metastatic resectable osteosarcoma, compared with chemotherapy alone. Mepact was granted orphan drug status in the U.S. in 2001 and in the European Union in 2004.

• Karo Bio AB, of Huddinge, Sweden, received approval for clinical studies of KB2115, a compound that stimulates the thyroid hormone receptor - the protein that mediates the effects of thyroid hormone. Specifically, it is designed to act selectively through the thyroid hormone receptor beta instead of the alpha receptor, which produces negative heart effects. Animal studies have shown that KB2115 increases the body's energy consumption while reducing body weight, blood lipids and blood glucose. Future study details were not disclosed.

• LifeCycle Pharma A/S, of H rsholm, Denmark, raised €15 million in a Series C round to fund clinical development and registration of its improved formulations of fenofibrate and tacrolimus, which are in development for lipid management and immunology indications, respectively. The company also plans to initiate programs in lipid management and immunosuppression. Alta Partners, of San Francisco, led the round. Alta co-founder Jean Deleage has joined LifeCycle's board.

• Max Planck Institute of Biochemistry in Munich, Germany, licensed technology for in vitro diagnostic detection of novel tumor-suppressive genes to OncoMethylome Sciences, of Durham, N.C. The technology relates to genes that are methylated in prostate cancer, but not in normal prostate tissue or benign prostatic hyperplasia. The company plans to use the intellectual property to develop a test for early detection, prognosis and monitoring of prostate cancer. Financial terms were not disclosed.

• Medarex Inc., of Princeton, N.J., and Ono Pharmaceutical Co. Ltd., of Osaka, Japan, entered an agreement to research and develop a fully human anti-PD-1 antibody for the potential treatment of cancer. Clinical studies could begin in 12 to 24 months. The companies will share costs and responsibilities up to the completion of a Phase II study. After that, Medarex is responsible for any continued development and commercialization in North America, while Ono is responsible for all areas outside of North America.

• Nikem Research Srl, of Milan, Italy, and Hybrigenics SA, of Paris, expanded and extended a research service agreement. Nikem will continue using its medicinal chemistry platform and expertise to optimize inhibitors of ubiquitin-specific proteases as new therapeutic agents against cancer. The family of proteases has been the focus of target identification and validation studies by Hybrigenics in the field of oncology.

• Onyvax Ltd., of London released data from the second cohort of its Onyvax-P Phase II trial, showing the cancer vaccine may provide clinical benefit to men with metastatic hormone-resistant prostate cancer. In 13 men whose disease had metastasized to the bone the median progression-free survival was 23 weeks, compared to an expected nine to 17 weeks. A pivotal Phase IIb/III trial is planned to start later in 2005.

• Oxford BioMedica plc, of Oxford, UK, announced further data in the Phase II trials of TroVax, its gene therapy, in combination with standard chemotherapy in treating metastatic colorectal cancer. The immune response data showed that the antibody levels against the 5T4 tumor antigen targeted by the product were four to 10 times higher than in the Phase I/II trial involving post-chemotherapy patients. In addition, anti-5T4 killer T-cells reached levels comparable to those seen in viral infections that are cleared by circulating antiviral killer cells.

• Roche Diagnostics, of Basel, Switzerland, formed a collaboration with Indianapolis-based Eli Lilly and Co., in which they will work with Response Genetics Inc., of Los Angeles, to confirm biomarkers that may be used to identify patients most likely to respond to certain cancer therapies. The first phase of the agreement specifically targets biomarkers linked to Lilly's Alimta (pemetrexed) and Gemzar (gemcitabine) cancer treatments. The goal is to confirm biomarkers suspected of being linked to patients' survival response rates.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., said it received a $20 million milestone payment from Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. for initiating a Phase III trial of lubiprostone to treat patients with constipation-predominant irritable bowel syndrome. Lubiprostone is a class of functional fatty acid that produces chloride channel-opening activity.

• Transgene SA, of Strasbourg, reported positive results from two Phase II trials of its anti-cancer vaccine MVA-MUC1-IL2 in prostate cancer and lung cancer. In the first, the vaccine induced a significant increase in the time during which the rate of prostate specific antigen (PSA) was doubled in 63 percent of patients, while in 30 percent of them the increase in the PSA rate lasted twice as long as before the treatment. In the second trial, in which MVA-MUC1-IL2 was administered in conjunction with a conventional chemotherapy regime to patients suffering from non-small cell lung cancer, a 37 percent response rate was achieved, while partial response and disease stabilization beyond 12 weeks was observed in 71 percent of subjects.