• Acorda Therapeutics Inc., of Hawthorne, N.Y., said it has filed a lawsuit against Apotex Corp. and Apotex Inc., of Weston, Ontario, in the U.S. District Court for the District of New Jersey asserting infringement of Acorda's U.S. Patent No. 6,455,557 relating to multiparticulate tizanidine compositions, such as those sold by the firm as Zanaflex capsules. The patent expires in 2021. The lawsuit is in response to a notice from Apotex that it had submitted an abbreviated new drug application to the FDA seeking marketing approval for generic versions of the firm's three dosage strengths of Zanaflex.

• Alpharma Inc., of Bridgewater, N.J., said its affiliate, Alpharma Ireland Ltd. has closed its previously announced agreement with IDEA AG, of Munich, Germany, to license exclusive U.S. rights to ketoprofen in Transfersome gel, a prescription topical nonsteroidal anti-inflammatory drug in Phase III clinical development. This license includes access to IDEA's Transfersome technology platform that delivers drugs locally to targeted areas. The transaction has been cleared by U.S. officials and Alpharma Ireland Ltd. has made a payment of $60 million and delivered to IDEA warrants for the purchase of shares of Alpharma's common stock that are exercisable only upon FDA approval of the product. In September Alpharma agreed to pay IDEA $60 million up front and three additional near-term payments totaling $77 million upon the achievement of certain regulatory and patent-related milestones. Upon FDA approval of Diractin, Alpharma will make a final milestone payment of either $45 million or $65 million, depending on the results of one of the clinical trials for the product. Alpharma also will pay IDEA royalties based on the annual level of sales achieved in the U.S. As part of the license transaction, IDEA also received warrants to purchase $100 million of Alpharma's common stock.

• Anesiva Inc., of South San Francisco, said it has partnered with Sagent Pharmaceuticals, of Schaumburg, Ill., to co-promote Zingo (lidocaine hydrochloride monohydrate), a powder intradermal injection system used to reduce pain associated with peripheral venous access procedures. The drug was approved by the FDA in August for use in children ages 3 to 18. (See BioWorld Today, Aug. 20, 2007.) Anesiva also announced a joint manufacturing venture with Wanbang Pharmaceuticals, of XuZhou, China, to expand worldwide production capacity for Zingo. Anesiva will own 49 percent of the joint venture, which will be named Wanbang/Anesiva Pharmaceuticals Ltd. Anesiva said Zingo will be available in commercial quantities in the second quarter of 2008.

• Biogen Idec Inc., of Cambridge, Mass., said new data on Avonex (interferon beta-1a) were presented at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Prague, Czech Republic. A post-hoc analysis of a Phase III Avonex trial and eight-year follow-up showed that patients on the drug during the trial were less likely to experience disability progression over time than placebo patients, and that progression at two years predicted progression at eight years. A second presentation indicated that Avonex patients were less likely to have discontinued therapy after two years than patients on Copaxone (glatiramer acetate, Teva Pharmaceuticals Inc.), Betaseron (beta interferon 1b, Berlex Laboratories Inc.) or Rebif (beta interferon 1a, Merck Serono). A third study showed that efficacy was similar among the different beta interferon products.

• Biotech Holdings Ltd., of Vancouver, British Columbia, said it has applied to delist its shares from the TSX Venture Exchange (CDNX:BIO) while continuing to list on the Over-the-Counter Bulletin Board (OTC BB:BIOHF). The company markets the insulin sensitizer Sucanon in Mexico and Latin America.

• BioTime Inc., of Emeryville, Calif., said it has named Michael D. West CEO. West, who has served on the BioTime board of directors since 2002, has extensive academic and business experience in age-related degenerative diseases, telomerase molecular biology and human embryonic stem cell research and development. Prior to joining BioTime, West served as director, president and chief scientific officer of Advanced Cell Technology Inc., of Los Angeles. West also founded Geron Corp., where he initiated and managed programs in telomerase diagnostics, telomerase inhibition as antitumor therapy and the cloning and use of telomerase to immortalize human cells.

• BrainStorm Cell Therapeutics Inc., of Petach Tikvah, Israel, has named Rami Efrati CEO. Efrati is a former commander of technological and operational elite units and a retired colonel of the Israeli Defense Forces.

• Cellestis Ltd., of Melbourne, Australia, received FDA approval for its QuantiFERON-TB Gold In-Tube blood test for tuberculosis. The test is intended to replace the first-generation QuantiFERON-TB Gold blood test as well as the 100-year-old tuberculin skin test.

• Genomic Health Inc., of Redwood City, Calif., said study results of Oncotype DX in postmenopausal women with node-positive, hormone receptor positive breast cancer suggested that the test may be useful in predicting survival without recurrence. Oncotype DX is a multigene expression test that physicians currently used to predict the likelihood of recurrence and the likelihood of chemotherapy benefit for women with estrogen receptor positive, node-negative breast cancer. Researchers analyzed tumor samples from patients in the SWOG/Breast Cancer Intergroup of North America trial that evaluated postmenopausal patients with node-positive, hormone receptor positive breast cancer who were treated with cyclophosphamide, doxorubicin, 5-fluorouracil followed by tamoxifen vs. tamoxifen alone. Benefit of the addition of chemotherapy was observed in patients with high Oncotype DX Recurrence Scores. However, chemotherapy did not appear to benefit patients with low Oncotype DX Recurrence Scores, despite the presence of positive nodes.

• Nanotherapeutics Inc., of Alachua, Fla., received a four-year, $20 million contract from the NIH's National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority to develop an inhaled version of the injectable antibiotic gentamicin for pneumonic plague and tularemia. The company is continuing development of an inhaled dry-powder formulation, called NanoGENT.

• Nile Therapeutics Inc., of Berkeley, Calif., said that its stock ticker symbol on the Over-the-Counter Bulletin Board has changed from "SPDU.OB" to "NILT.OB." The firm's lead compound, CD-NP, a novel chimeric peptide, is currently in Phase I studies for the treatment of heart failure. The company also is developing 2NTX-99, a small-molecule, preclinical, anti-atherothrombotic agent with nitric oxide donating properties.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., has licensed from the Massachusetts Institute of Technology intellectual property rights related to the enzyme SIRT1. SIRT1 is a sirtuin used as a drug target in treating metabolic, cardiovascular and neurological diseases. No terms were disclosed.