• Acorda Therapeutics Inc., of Hawthorne, N.Y., said it received notice fromApotex Inc., of Toronto, that Apotex has filed an abbreviated new drug application for generic versions of the three Zanaflex Capsules (tizanidine hydrochloride) dosage strengths. Acorda said it was reviewing the notice.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it is participating in a $22 million Roadmap Grant from the National Institutes of Health awarded to scientists at UT Southwestern Medical Center for research on obesity. In the funded research, Alnylam will design, synthesize and optimize RNAi therapeutic compounds toward disease targets involved in the cause or pathway of obesity discovered at UT Southwestern. Alnylam retains the rights to develop and commercialize RNAi therapeutics from the research effort.

• Alpharma Inc., of Bridgewater, N.J., said an affiliate licensed exclusive U.S. rights to ketoprofen in Transfersome gel from IDEA AG, of Munich, Germany. The product is a topical non-steroidal anti-inflammatory drug in Phase III clinical development. The license includes access to IDEA's Transfersome technology platform. IDEA in May submitted a marketing authorization application in Europe on the product for the treatment of osteoarthritis. A prior regulatory submission with Swiss regulators was approved by SwissMedic in June. Terms include a $60 million payment to IDEA at closing, along with $77 million in potential clinical and regulatory milestone payments, and $45 million or $65 million on FDA approval.

• Aradigm Corp., of Hayward, Calif., and CyDex Inc., of Lenexa, Kan., entered a two-year collaboration to develop and commercialize combination products containing inhaled corticosteroids, anticholinergics and beta-2 agonists for treating asthma and chronic obstructive pulmonary diseases. Aradigm will cover 60 percent of collaboration costs, and CyDex 40 percent. Any third-party licensing and sales revenues would be shared in the same ratio. The effort will combine Cydex's aqueous formulation capabilities with Aradigm's AERx Essence inhalation delivery system.

• Athersys Inc., of Cleveland, completed its planned name change from BTHC VI Inc., following a reverse merger in June. The new ticker symbol on the Over-the-Counter Bulletin Board is "AHYS." The operations of Athersys and its affiliates constitute the sole business of the merged company. (See BioWorld Today, June 12, 2007.)

• Aureon Laboratories Inc., of Yonkers, N.Y., has completed a development project with AstraZeneca plc, of London, to identify patients with non-small-cell lung cancer who may benefit from treatment with Iressa (gefitinib). The project was accomplished by integrating a patient's clinical data with tumor biomarker profiles and image analysis features using on-slide technologies and machine learning approaches developed at Aureon.

• Cell Therapeutics Inc., of Seattle, said that after discussions with the FDA regarding its pixantrone EXTEND trial for patients with aggressive non-Hodgkin's lymphoma, the company has decided to conduct a full analysis of the trial instead of an interim analysis previously planned. The decision was based in part on FDA guidance that a primary endpoint analysis of less than the initially-projected 320 eligible patients could be acceptable for new drug application submission if it is able to demonstrate a statistically significant difference between treatment arms. The company said the FDA agreed that randomized safety data from the RAPID study could be used to support the EXTEND results in an NDA submission for pixantrone. The company expects to complete enrollment in the EXTEND trial in the fourth quarter of this year with primary endpoint data and final results being reported in the first half of 2008.

• Crucell NV, of Leiden, the Netherlands, granted a nonexclusive STAR research license to Invitrogen Corp., of Carlsbad, Calif. The license covers the production of monoclonal antibodies. Terms were not disclosed.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said its intravenous antibiotic Cubicin (daptomycin for injection) was approved for additional indications in the European Union. Licensee Novartis AG, of Basel, Switzerland, said approval was based on Staphylococcus aureus bacteremia and endocarditis trials. The two new approved indications are right-sided infective endocarditis (RIE) due to S. aureus, and S. aureus bacteremia, when associated with RIE or with complicated skin and soft-tissue infections. Cubicin originally approved by the European Commission in January 2006 for use in treating cSSTI infections caused by certain Gram-positive bacteria.

• Encysive Pharmaceuticals Inc., of Houston, said it received a written response from the FDA regarding its request for formal dispute resolution on its new drug application for Thelin (sitaxsentan sodium) for the treatment of pulmonary arterial hypertension. The FDA's reviewer agreed with the decision of the Division of Cardiovascular and Renal Products that data did not provide the substantial evidence of effectiveness needed for approval. The reviewer encouraged the company to conduct an additional study to demonstrate the drug's effectiveness in exercise capacity as measured by change in six-minute walk distance. Encysive officials said they are reviewing the FDA response. (See BioWorld Today, June 19, 2007.)

• Innocoll Inc., of Ashburn, Va., agreed to sell its CollaRx Gentamicin Surgical Implant European sales and marketing infrastructure to EUSA Pharma Inc., of Doylestown, Pa. EUSA got rights to the product, a biodegradable surgical implant for treating and preventing surgical site infections, for all worldwide markets except the U.S. Similar rights to Innocoll's two late-stage development products, CollaRx Gentamicin Topical and CollaRx Bupivacaine Implant, were included in the deal, along with an option to the U.S. rights for Bupivacaine Implant. Innocoll is entitled to an up-front payment and potential development and sales milestones.

• IsoTis Inc., of Irvine, Calif., filed a definitive proxy statement in connection with its planned merger with Integra LifeSciences Holdings Corp., of Plainsboro, N.J. The proxy statement relates to an Oct. 11 special meeting of IsoTis stockholders, who will be asked to approve the $51 million acquisition by Integra. (See BioWorld Today, Aug. 8, 2007.)

• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA's Antiviral Drugs Advisory Committee unanimously recommend accelerated approval of Isentress (raltegravir) in combination with other antiretroviral therapy for the treatment of HIV infection in treatment-experienced patients with ongoing viral replication despite existing therapy. Isentress would be the first in a new class of antiretroviral agents called integrase inhibitors. The FDA is not bound by the committee's recommendation but takes its advice into consideration when reviewing investigational medicines. The FDA previously granted Merck priority review status for the drug, and the company anticipates FDA action by mid-October.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., signed a Cooperative Research and Development Agreement with the National Institute of Aging. Sirtris and academic collaborators were awarded funding to study the effects of one of its new chemical entities on diseases of aging in mice. The compound, which is structurally distinct from, and significantly more potent than Sirtris' resveratrol product (SRT501), will be tested in aging mice, Sirtris said. Diseases being evaluated include metabolic, neurological and inflammatory disorders, and cancer. Terms of the CRADA were not disclosed.

• SymBio Pharmaceuticals Ltd., of Tokyo, obtained exclusive global rights to poly(ethylene glycol)-conjugated zinc protoporphyrin (PEG-ZnPP), a water-soluble derivative of ZnPP. The product from Sojo University in Japan has shown activity against Gleevec-resistant leukemia cells. SymBio plans to find a partner for U.S. development.

• The Feinstein Institute for Medical Research in Manhasset, N.Y., said it and collaborators identified a gene that increases a person's risk for rheumatoid arthritis and systemic lupus erythematosus, and may be involved with other autoimmune diseases. They used genetic mapping technology to analyze DNA from 2,500 RA and lupus patients, and identified STAT4 as a culprit in susceptibility to both diseases. The genetic link is described in the Sept. 6 issue of the New England Journal of Medicine.