• Acambis plc, of Cambridge, UK, started a Phase I trial of its vaccine against Clostridium difficile. The trial is designed to test the safety, tolerability and immunogenicity of Acambis' vaccine when administered at different dose levels. It is being conducted at two study centers in the U.S., and Acambis plans to start a second Phase I trial in elderly subjects.

• Biolex Therapeutics Inc., of Pittsboro, N.C., acquired LemnaGene SA, of Lyon, France, a company that provides biomanufacturing services to various markets, and one that has several research agreements in the pharmaceutical and human/animal vaccine areas. The acquisition gives Biolex protein capabilities.

• Biolog Inc., of Hayward, Calif., is extending its collaboration with Axiohelix, of Tokyo, and the NARA Institute in Nara, Japan, to phenotype and determine the function of each gene in the E. coli genome. Biolog began using its Phenotype MicroArray technology in November on the E. coli K-12 strain library developed at the institute, a collection that contains strains for which each gene in the genome has been mutated or knocked out. It is expected that the analysis will be expanded to the entire E. coli genome next year.

• Biota Holdings Ltd., of Melbourne, Australia, has assessed the damages caused by partner London-based GlaxoSmithKline plc's alleged neglect in supporting the influenza drug, Relenza. It listed in its May 2004 lawsuit losses of between $234 million and $326 million. The assessment accounts for a conservative and a moderate market growth scenario, it said, and assumes Relenza would have achieved a 40 percent market share, instead of the 1 percent worldwide share it now holds.

• EvoGenix Ltd., of Sydney, Australia, closed its initial public offering, raising A$9 million (US$6.8 million) through the issue of 36 million shares at A$0.25 cents each. The company is expected to list on the Australian Stock Exchange in early August with a post-listing market capitalization at the issue price of A$32.2 million. The company focuses on identifying and developing antibody-based drugs.

• GammaCan International Inc., of Givat Shmuel, Israel, said it initiated a Phase II trial of GCAN 101 for the treatment of metastatic melanoma, prostate and/or colon cancers. The company's drug is based on IVIg, described as a relatively non-toxic human plasma-based product used to treat immune deficiencies and autoimmune diseases.

• Gentium SpA, of Villa Guardia, Italy, said underwriters of its initial public offering exercised their overallotment option to purchase 300,000 of the company's American depository shares at $9 each, for $2.7 million more in proceeds added to the $21.6 million already raised. Maxim Group LLC and I-Bankers Securities Inc. served as co-managers of the offering. Gentium is focused on developing drugs derived from DNA extracted from natural sources and drugs that are synthetic oligonucleotides to treat vascular diseases and conditions related to cancer and cancer treatments.

• GTC Biotherapeutics Inc., of Framingham, Mass., and Scancell Ltd., of Nottingham, UK, signed an agreement to evaluate the expression of Scancell's SC101 cancer monoclonal antibody using GTC's transgenic production platform. The agreement contemplates that both companies will work toward establishing a definitive agreement for the clinical development of SC101.

• MAP Pharmaceuticals Inc., of Mountain View, Calif., and Elan Corp. plc, of Dublin, Ireland, amended their 2004 agreement to apply Elan's NanoCrystal technology to defined inhalation therapies. The companies have been collaborating to develop a nebulized form of budesonide to treat asthma. The agreement provides additional rights to MAP for the use of NanoCrystal technology to treat multiple respiratory diseases, including asthma.

• MerLion Pharmaceuticals Pte. Ltd., of Singapore, extended its existing collaboration with Whitehouse Station, N.J.-based Merck & Co. Inc. to discover and develop new drug candidates derived from natural products chemistry. The agreement extends the term for an additional two years, increases the number of validated drug targets under collaborative research, and includes the discovery and development of new animal health care products. MerLion will provide access to its sample collection for selected targets, and work to isolate new chemical leads, in return for up-front payments, milestones and royalties.

• Morria Biopharmaceuticals plc, of London, said its leading inhaled drug candidate, MRX3, ameliorated asthma symptoms and reduced the levels of several key inflammatory mediators in preclinical trials in animals. Results of the studies appear in the current issue of Thorax.

• Nanogen Inc., of San Diego, made an equity investment in Jurilab Ltd., a Kuopio, Finland-based company focused on the discovery and identification of new genes and gene markers associated with common diseases and drug responses. Nanogen will acquire certain rights to develop diagnostic products based on genes and gene markers discovered by Jurilab. Nanogen initially invested €1.25 million (US$1.5 million) for a less than 20 percent equity interest, and it will invest an equal amount within six months.

• Schering AG, of Berlin, and AstraZeneca plc, of London, entered a research collaboration and licensing agreement in selective glucocorticoid receptor agonists. The companies will work together up to the end of Phase I trials to identify novel SEGRAs. Under the three-year agreement, AstraZeneca will have an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases, while Schering will have the same for all other indications. Schering will receive up-front fees, and both parties might benefit from downstream milestone payments and royalties. Also, Schering and Novartis Pharma AG, of Basel, Switzerland, said an interim review by an Independent Safety Monitoring Board of the CONFIRM 2 trial with PTK/ZK in cancer showed that the trial had a low probability of demonstrating an improvement in overall survival at final analysis. The companies said investigators will be informed of the board's findings to allow for discussion as to whether treatment should continue. The Phase III CONFIRM 2 trial was designed to evaluate the potential overall survival benefit of once daily oral treatment with PTK/ZK in combination with chemotherapy (FOLFOX-4 regimen) as second-line therapy in patients with metastatic colorectal cancer.

• Sinovac Biotech Ltd., of Beijing, China, said the State Food and Drug Administration issued a production license for the company's influenza flu vaccine, Anflu. The company received a new drug certificate for Anflu in March, but it now can begin vaccine production, and marketing will begin in late summer. Sinovac markets two other vaccine products in China, including Healive for hepatitis A, and Bilive for hepatitis A and hepatitis B.

• Transkaryotic Therapies Inc., of Cambridge, Mass., and Shire Pharmaceuticals Group plc, of Basingstoke, UK, said shareholders at each company approved the $1.6 billion cash acquisition of TKT by Shire. The acquisition is expected to be completed last week.

• UCB Pharma Inc., of Smyrna, Georgia, the U.S. headquarters of Brussels, Belgium-based UCB, announced positive results for two pivotal Phase III trials of certolizumab pegol for Crohn's disease. The Precise 1 and 2 trials assessed the safety and efficacy of Cimzia, a PEGylated Fab' fragment of a humanized anti-TNF alpha monoclonal antibody, compared to placebo over a 26-week period and in a total of 1,330 patients with active disease. The data will be presented in detail at an upcoming gastroenterology medical meeting.

• Wilex AG, of Munich, Germany, said it completed its first Phase I trial of its oral anticancer compound WX-671. The study investigated the oral bioavailability, pharmacokinetics and safety at four dose levels in 16 healthy male volunteers. WX-671 is a second generation serine protease inhibitor targeting the uPA (urokinase Plasminogen Activator) system, which has been shown to play a role in metastasis and primary tumor growth of breast cancer and other solid tumors.

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