• Celgene International Sarl, of Boudry, Switzerland, said the European Committee for Medicinal Products for Human Use issued a negative opinion for Lenalidomide for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a 5q deletion. Celgene said the CHMP concluded that the drug had shown efficacy in that patient group, but was not convinced that the safety data were sufficient. The company plans to apply for a re-examination of the CHMP opinion in accordance with EMEA procedures. In Canada, the drug gained conditional marketing approval for patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with the 5q deletion. Revlimid (lenalidomide) previously gained FDA approval in that same indication. Celgene also reported that, in Australia, Revlimid received marketing approval for use in combination with dexamethasone in multiple myeloma patients whose diseases have progressed after one therapy.

• Cerenis Therapeutics SA, of Toulouse, France, appointed Rob Scott as chief medical officer. Scott previously was executive vice president of research and development at AtheroGenics Inc., and before that was worldwide head of the cardiovascular and metabolic group at Pfizer Inc. Cerenis is specialized in the development of HDL compounds for the treatment of cardiovascular and metabolic diseases.

• Eisai Co. Ltd., of Tokyo, completed the offer by its indirect wholly owned subsidiary, Jaguar Acquisition Corp., to purchase all outstanding shares of the common stock of MGI Pharma Inc., of Bloomington, Minn., for $41 per share. As the final step of the acquisition process, Eisai said it intends to effect a short-form merger of Jaguar into MGI Pharma, with the remaining MGI Pharma shareholders receiving the same cash price of $41 per share. Following the merger, MGI Pharma will become a wholly-owned subsidiary of Eisai Corp and MGI Pharma common stock will be delisted and will cease to trade on Nasdaq.

• Emergent BioSolutions, of Rockville, Md., and Ninebio Sdn. Bhd., of Putrajaya, Malaysia, have formed a joint venture in Malaysia to create a biologics infrastructure and supply biodefense countermeasures, including BioThrax (anthrax vaccine absorbed), and other medical and complementary products and services to the government of Malaysia. The venture also will seek to supply products and services to other member countries of the Organization of the Islamic Conference and other countries within Asia.

• Galapagos, of Mechelen, Belgium, has achieved a milestone with its GT146 program in rheumatoid arthritis, entitling it to payment of €3.4 million (US$5.1 million) from Janssen Pharmaceutica, of Titusville, N.J., under its October 2007 alliance agreement. Janssen has option rights under the agreement to acquire worldwide commercial licenses to novel small molecules from up to 12 of Galapagos' internal programs involving rheumatoid arthritis therapeutic targets.

• Gastrotech Pharma, of Copenhagen, Denmark, has signed an agreement with Eli Lilly and Co., of Indianapolis, to in-license the Lilly compound now named GTP-010, an analogue of the naturally occurring intestinal hormone GLP-1. The deal follows positive clinical data from a joint Lilly and Gastrotech proof-of-concept study to assess pain reduction associated with irritable bowel syndrome. Gastrotech now plans to develop GTP-010 to treat IBS. Under the terms of the agreement, Gastrotech will receive a global exclusive license to develop and market GTP-010 for IBS and functional dyspepsia. Lilly will take an equity stake in Gastrotech and will receive royalties on sales. Financial details were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, has reached the second and third development milestones for ofatumumab (HuMax-CD20(R)) under the terms of its collaboration with GlaxoSmithKline, of London. The second milestone payment of DKK87.2 million (US$17 million) was triggered by treatment of the first patient in the Phase II study of ofatumumab in diffuse large B-cell lymphoma in 2007. The third milestone payment of DKK87.2 million was triggered by the first patient receiving treatment in the Phase III rheumatoid arthritis program, which occurred earlier this month.

• Geron Corp., of Menlo Park, Calif., and Sienna Cancer Diagnostics, of Melbourne, Australia, have signed a licensing agreement giving Sienna access to patents and information related to the detection or measurement of telomerase activity. Under the terms of the license, Sienna gains worldwide exclusive rights within a defined field to Geron-controlled intellectual property to detect telomerase activity for the cancer in vitro diagnostics market. In exchange, Geron received an undisclosed equity interest in Sienna and is entitled to receive royalties on future product sales.

• Hadasit, the technology transfer company of Hadassah Medical Organization in Jerusalem, and Harvard Medical School and Brigham and Women's Hospital of Boston, said they have partnered to develop a new orally administered combination therapy for autoimmune diseases. The combination therapy is a cocktail of an Anti-CD3 monoclonal antibody in development at Harvard Medical School and a line of glycolipid compounds in development at Hadasit. Clinical data have shown that the glycolipid compounds, which activate specific cells in the immune system when given orally, can be used for all oral applications and without adverse side effects. Preclinical studies demonstrated the same results for the monoclonal antibody, but in animal models.

• Lipoxen Plc, of London, said a Phase I trial of SuliXen, its long-acting insulin product for Type 1 and Type 2 diabetes, has started at the Federal State Center of Endocrinology in Moscow. SuliXen is the first of Lipoxen's products to enter clinical trials. The study will involve 12 healthy volunteers who will each receive two doses of SuliXen (0.1IU/kg and 0.3IU/kg) in comparison with the long-acting, insulin analogue, insulin dosed at 0.2IU/kg. SuliXen, is formulated with Lipoxen's PolyXen delivery technology, which is based on polysialic acid, a naturally occurring polymer which is biodegradable, nonimmunogenic and nontoxic, and is expected to avoid the toxicity attributed to polyethylene glycol in PEGylated protein drugs.

• SciGen Ltd., of Sydney, Australia, said it has been awarded the GMP certification for its manufacturing facility in Rehovot, Israel where its third-generation hepatitis B vaccine Sci B Vac is manufactured. GMP certification is a prerequisite for the renewal of health registration in those countries where Sci B Vac previously was registered prior to the change of manufacturing site and the start of health regulatory submissions in all parts of the world including the EMEA in Europe, the FDA in the U.S. and other major health regulatory agencies.

• Sinovac Biotech Ltd., of Beijing, has entered into a securities purchase agreement with an unnamed institutional investor for a private placement of 2.5 million shares of its common stock to an institutional investor, which will raise about $9.75 million in gross proceeds. The shares were priced at $3.90 each, the last closing price prior to signing of the agreement. Sinovac specializes in developing vaccines against infectious diseases, and has products in hepatitis A and B, influenza, and is developing vaccines against the H5N1 strain of pandemic influenza and Japanese encephalitis.

• TransTech Pharma Inc., of Bagsvaerd, Denmark, said it has acquired all rights from Novo Nordisk AS, also of Bagsvaerd, to a portfolio of drug candidates, including H3 receptor antagonists, PPARd agonists, and 11-beta HSD1 inhibitors, being developed to treat metabolic disorders. TransTech's current diabetes and obesity portfolio includes orally administered and novel therapeutic development candidates targeting PTP1b inhibitors, AgRP inhibitors, GLP1R agonists, AMPK activators and glucokinase activators.