• Abbott, of Abbott Park, Ill., simultaneously submitted a supplemental biologics license application to the FDA and a Type II Variation to the European Medicines Agency, seeking approval to market Humira (adalimumab) as a treatment for moderate to severe chronic plaque psoriasis. Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in the U.S. and Europe.

• Alkermes Inc., of Cambridge, Mass., submitted marketing authorization application in the UK and Germany for Vivitrol (naltrexone for extended-release injectable suspension) for once-monthly treatment of alcohol dependence. The filing was submitted under a decentralized procedure, which, if successful, would result in simultaneous approval in both countries. Vivitrol gained U.S. approval in April 2006. (See BioWorld Today, April 17, 2006.)

• Amazon Biotech Inc., of New York, has entered into negotiations with major pharmaceutical companies for funding of future studies and marketing of the company's anti-HIV drug, AMZ0026, which has been shown to have potential benefits on the immune system of immunodeficient HIV/AIDS patients, particularly with respect to elevation of CD4 levels in preliminary clinical case studies. The company has retained Stanley Fass, formerly of Intec Pharma Ltd., to negotiate a joint venture agreement with pharmaceutical companies.

• Anavex Life Sciences Corp., of Geneva, entered a research agreement with the department of Pharmacology and Biological Sciences at Paris 5 University-Rene Descartes in Paris to investigate the neuroprotective action of the company's tetrahydrofuranic compound ANAVEX 19-144 in transient focal cerebral ischemia animal models. The research program involves a preliminary study of the effects of the drug on mean arterial blood pressure and a main study on cerebral ischemia. Terms were not disclosed.

• CSL Behring, of King of Prussia, Pa., said the FDA granted marketing approval for Rhophylac Rh0 (immune globulin intravenous [human]), an anti-D Rh immunoglobulin, in immune thrombocytopenic purpura. Rhophylac is indicated to raise platelet counts in Rh0 (D)-positive, non-splenectomized adult patients with ITP. The drug previously gained approval in the prevention of hemolytic disease of the fetus and newborn and to treat Rh-negative individuals in the event of an incompatible blood transfusion.

• Depomed Inc., of Menlo Park, Calif., has filed a prior approval supplement with the FDA seeking to market 1,000 mg strength tablets of Glumetza (metformin hydrochloride extended-release tablets). The company expects a ruling before the end of the third quarter of this year. The new formulation would replace the 1,000 mg strength tablet currently covered by the Glumetza New Drug Application. The supplement filed with the FDA includes data from a comparative bioavailability study demonstrating that the 1,000 mg strength tablets achieved equivalent peak and systemic exposure when compared to Glumetza 500 mg tablets given as two tablets under single-dose fed conditions. No serious adverse events were reported.

• Diosynth Biotechnology, of Research Triangle Park, N.C., signed an agreement with Talecris Biotherapeutics Inc., also of Research Triangle Park, N.C., for process development activities and cGMP production of clinical trial material for a form of recombinant plasminogen, an intermediate material used in making recombinant Plasmin. Talecris is developing Plasmin, a second-generation therapy, in ophthalmic and thrombolytic indications. Financial terms were not disclosed.

• Encysive Pharmaceuticals Inc., of Houston, launched Thelin (sitaxentan sodium) 100 mg tablets in the Republic of Ireland for the treatment of pulmonary arterial hypertension. The company received European Union marketing authorization for Thelin from the European Commission in August 2006. The drug is the first selective endothelin A receptor antagonist and the first once-daily oral treatment available for patients with PAH. In the U.S. at the start of this year, the FDA accepted for review Encysive's complete response to the July 24, 2006, approvable letter for Thelin, and issued a new PDUFA data of June 15, 2007. (See BioWorld Today, July 26, 2006.)

• EPIX Pharmaceuticals Inc., of Lexington, Mass., said it expects a response from the FDA late in the second quarter regarding its formal appeal seeking approval of its blood-pool imaging agent Vasovist (gadofosveset trisodium). The company submitted the appeal to the FDA's Center for Drug Evaluation and Research division in February and is in ongoing discussions with the agency but said the decision-making process is expected to extend past the 30-day period originally anticipated. Vasovist is approved in Europe, Canada and Australia, though U.S. regulators have requested additional information relating to the comparator scans used in clinical trials. Vasovist's initial target indication is for use in magnetic resonance angiography imaging of non-coronary vascular disease.

• Genencor International Inc., of Rochester, N.Y., a division of Copenhagen, Denmark-based Danisco A/S, granted Pfizer Inc., of New York, a nonexclusive license to technology that enhances the expression level of secreted polypeptides in microorganisms for use in the development of protein therapeutics. The technology is designed to improve processes for protein production, which in turn might reduce development costs for protein-based drugs. Terms of the deal were not disclosed.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, has extended the closing of the spinout of Tekmira Pharmaceuticals Corp. from March 31 to April 30, 2007 at the request of the group investing approximately $5.6 million in INEX as part of the transaction. The group requested the extension to complete their final due diligence.

• Janus Pharmaceuticals Inc., of Pasadena, Calif., gained rights for exclusive development and sales of antifungal drug Luliconazole from Tokyo-based Nihon Nohyaku Co. Ltd. (NNC) for North America, Europe and South America. Luliconazole was co-developed by NNC and Pola Pharma Inc., also of Tokyo, and has been sold in Japan since 2005 under the trade name Lulicon for athlete's foot. Financial terms were not disclosed.

• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA approved Janumet, a tablet combining a dipeptidyl peptidase-4 inhibitor, sitagliptin (also known as Januvia), and metformin for Type 2 diabetes. The combo tablet has been cleared as an adjunct to diet and exercise to improve blood sugar (glucose) control in adult patients not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin.

• Neurotune AG, of Zurich, Switzerland, and Nikem Research Srl, of Milan, Italy, entered a 12-month service agreement at the start of February. Under the terms, NiKem will make its integrated platform available to Neurotune, including medicinal, parallel and analytical chemistry, exploratory ADMET profiling and in vivo pharmacokinetics. The collaboration aims to design, synthesize and optimize compounds against Neurotune proprietary target neurotrypsin. Financial terms were not disclosed.

• Novavax Inc., of Rockville, Md., said its virus-like particle (VLP) vaccine triggered an immune response and provided protection against the H9N2 strain of avian influenza. The vaccine was tested in three animal models, including the ferret, which is believed to be a predictive model for human efficacy. Protection was measured by a reduction in viral load in vaccinated ferrets challenged with live H9N2 avian flu. Data were published in the online edition of Vaccine.

• Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, has granted options to acquire a total of 997,000 common shares of Pacgen and cancelled options to acquire 300,000 common shares relating to compensation for the past and current CEOs. David Cheng, Pacgen co-founder and former CEO, has agreed to cancel his options to acquire 240,000 shares. Newly appointed CEO Robert DuFresne was granted options to buy 500,000 common shares at an exercise price of C$0.65 through March 27, 2015. Pacgen also granted options to its non-executive directors to purchase 120,000 common shares of Pacgen at C$1.05 per share until March 6, 2012.

• Pfizer Inc., of New York, said that two subsidiaries of Pharmacia, which it bought in 2003, have agreed to pay $34.7 million in fines relating to off-label marketing of the human growth hormone Genotropin and the inappropriate use of a vendor contract to increase the sales of other Pharmacia medicines. Both settlements cover activities that occurred at Pharmacia before Pfizer bought it. One subsidiary - Pharmacia & Upjohn Company Inc. - will plead guilty to a single count of offering to an outside vendor a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines. The contract was awarded in 2000. The subsidiary, which has no operational role in Pfizer today, was fined $19.7 million and will be disqualified from participation in government health care programs. The agreement will not affect the continued marketing of Genotropin. A second Pharmacia subsidiary - Pharmacia & Upjohn Company LLC - has entered into a deferred prosecution agreement that includes a fine of $15 million for improperly promoting Genotropin. Pfizer discovered the improprieties and reported them to the DOJ, the FDA and the Office of the Inspector General within the first month following its completion of the Pharmacia acquisition. Under the agreement, no criminal charges will be filed against Pharmacia. According to the settlement, the subsidiary improperly promoted Genotropin between January 2000 and March 2003 for anti-aging purposes, improved athletic performance and enhanced appearance. The settlement does not allege that patients suffered any harm from those off-label uses. Genotropin is FDA-approved for the treating children with hormone-related growth failure, pediatric patients with Prader-Willi Syndrome and adults with growth hormone deficiency.

• Rosetta Genomics Ltd., of Rehovot, Israel, said its microRNA extraction protocol from blood serum enables the sensitive detection of microRNAs with virtually no microRNA lost in the process. Data were presented at the Cambridge Healthtech Institute's microRNA in Human Disease and Development Conference in Boston. The company also presented data from its lead therapeutic program in liver cancer, in which several potential microRNA targets have been isolated that when inhibited in vitro can lead to a decrease in cancer cell proliferation. That program is partnered with Carlsbad, Calif.-based Isis Pharmaceuticals Inc.

• Senetek plc, of Napa, Calif., signed a monetization agreement with Aliso Viejo, Calif.-based Valeant Pharmaceuticals North America Inc., the lead licensee of its Kinetin anti-aging active ingredient and the exclusive licensee of Zeatin, a Kinetin analog. Under the agreement, Senetek granted Valeant a paid-up license for both and assigned Valeant future royalties from other Kinetin licensees. In return, Senetek will receive a cash payment of $21 million, forgiveness of a $6 million prepaid royalty credit reimbursement obligation and a right to share in future royalties due to Valeant from other Kinetin licensees through 2011. Senetek said the transaction will provide working capital to accelerate pipeline development, to acquire products and meet the company's goal of commercializing one new compound each year.

• Trimeris Inc., of Morrisville, N.C., reported in an SEC filing that it is trimming its work force in light of its recently completed reorganization following the transfer of a number of responsibilities for its marketed HIV drug, Fuzeon, to partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The company estimates that the reduction will be completed by April 15, 2007. Though it did not specify the number of employees that would be affected, the company anticipates a one-time charge of $1.1 million associated with the terminations. The company previously reduced its work force in November to boost in earnings. Last month, Trimeris regained all rights to its next-generation HIV fusion inhibitor program from Roche, news that dropped the company's stock nearly 30 percent to close at $7.12. Shares of Trimeris (NASDAQ:TRMS) closed at $6.86 Monday, down 2 cents.

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