• Basilea Pharmaceutica Ltd., of Basel, Switzerland, filed its new drug submission for oral alitretinoin with Health Canada, seeking to get the drug approved in severe refractory chronic hand eczema. Marketing applications have been filed also in Switzerland and in several European Union member states.

• Centocor Inc., of Horsholm, Pa., and Schering-Plough Corp., of Kenilworth, N.J., revised their 1998 distribution agreement for Remicade (infliximab) and golimumab, Centocor's next-generation inhibitor of tumor necrosis factor-alpha that is in Phase III development. Effective upon approval of golimumab in the European Union, the revised agreement will extend the duration of Schering-Plough's rights to exclusively market Remicade in its current marketing territories outside the U.S. beyond 2014, which will match the current duration of marketing rights for golimumab. Schering-Plough's marketing rights to both products now will extend for 15 years after the first golimumab sale. In addition, Centocor will receive a progressively increased share of profits on sales of both products between 2010 and 2014, and will remain fixed thereafter for the remainder of the term. Schering-Plough will have the right to independently develop and market golimumab for Crohn's disease in its territories, with an option for Centocor to participate.

• FASgen Inc., of Baltimore, reported research showing that obesity candidate FAS89B, a selective inhibitor of brain carnitinepalmitoyl-transferase-1 (CPT-1), produced in vivo results in mice of decreased feeding for three days and persistent weight loss of six days, with no evidence of conditioned taste aversion. FASgen has a long-standing cooperation with Johns Hopkins University to conduct joint research based on discoveries in the regulation of weight loss by stimulating CPT-1.

• Illumina Inc., of San Diego, said the U.S. Patent and Trademark Office ordered the re-examination of U.S. Patent Nos. 6,355,432 and 6,646,243, which are the subject of an infringement suit filed against Illumina by Santa Clara, Calif.-based Affymetrix Inc. in July 2004. In its request for re-examination, Illumina asked the office to look at all claims. The process is expected to take about a year.

• ImaRx Therapeutics Inc., of Tucson, Ariz., submitted a lot release request to the FDA seeking extended expiration dating on its inventory of the thrombolytic drug urokinase and the release of one lot of drug product for commercialization. The request was based on stability testing that the company said met the required specifications. ImaRx acquired the FDA-approved drug from Abbott, of Abbott Park, Ill., and has generated approximately $14.4 million in net proceeds since October 2006. Shares of ImaRx (NASDAQ:IMRX) fell 32 cents, or 12.6 percent, to close at $2.23 on Friday.

• Incyte Corp., of Wilmington, Del., sold its ownership position in privately held life science company Velocity 11 in exchange for $8.5 million. Following a one-year escrow period, Incyte may receive an additional $900,000. Incyte is developing clinical-stage small molecules for diabetes, cancer, HIV and inflammatory diseases.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said Bayer Healthcare, a unit of Leverkusen, Germany-based Bayer AG, is discontinuing marketing on Viadur (leuprolide acetate implant), which is indicated for the palliative treatment of advanced prostate cancer. As a result, Indevus' Vantas (histrelin implant) will be the only 12-month implant for that indication. Indevus said it would help to enable a smooth transition of patients from Viadur to Vantas.

• Ista Pharmaceuticals Inc., of Irvine, Calif., submitted a new drug application for approval of bromfenac ophthalmic solution drug as a once-daily treatment for inflammation, pain and photophobia after cataract surgery. Under the brand name Xibrom, bromfenac ophthalmic solution is a topical nonsteroidal anti-inflammatory drug compound indicated for treating ocular inflammation and pain, approved in 2005 as the only FDA-approved twice-daily NSAID indicated for treating post-cataract surgery inflammation and pain.

• Medivir AB, of Stockholm, Sweden, said Presidio Pharmaceuticals Inc., of San Francisco, elected to return rights to MIV-310, an HIV nucleoside reverse transcriptase inhibitor, which allows Medivir to transfer the full license to the compound and intellectual property to Beijing Mefuvir Medicinal Technology Co. Ltd., of China. Mefuvir will develop MIV-310 for therapeutic use. Medivir licensed MIV-310 and MIV-410 to Presidio in a December 2006 deal valued at $75.3 million. Due to the transfer of MIV-310, financial terms were adjusted, leaving $52.3 million in milestones for continued development of MIV-410, which was not affected by the transfer. MIV-310 is the second drug from Medivir's polymerase program to be licensed to Mefuvir. In August, Mefuvir gained rights to MIV-160 for HIV prophylactic and therapeutic use.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., submitted a supplemental new drug application for Velcade (bortezomib) in patients with previously untreated multiple myeloma, based on data from a 682-patient Phase III trial. Partner Janssen-Cilag, a unit of New Brunswick, N.J.-based Johnson & Johnson, submitted a marketing authorization application in Europe. If approved, Velcade's use would be expanded from patients with relapsed disease to those who previously have not been treated.

• Ore Pharmaceuticals Inc., of Gaithersburg, Md., received a Nasdaq notice indicating that the company's shares closed below the $1 minimum bid price for 30 consecutive business days. The company has 180 days, or until June 11, 2008, to regain compliance or risk delisting.

• Solagran Ltd., of Melbourne, Australia, said the firm is on track to start commercial production of its liver protectant Ropren in January 2008. Ropren was registered as a new and low-side-effect pharmaceutical to treat chronic liver disease (hepatitis and cirrhosis) by the Russian Ministry of Health in July. Since then, Solagran has been working with its Russian associate SibEX to build a production facility capable of meeting the first wave of demand.

• Solstice Neurosciences Inc., of Malvern, Pa., appointed its board chairman, Dennis Smith, to the positions of president and CEO. Smith previously served as president and CEO of specialty pharmaceutical firm INO Therapeutics LLC. Solstice markets the botulinum toxin Type B product, Myobloc, for cervical dystonia.

• Tibotec Pharmaceuticals Ltd., a Cork, Ireland-based unit of New Brunswick, N.J.-based Johnson & Johnson, submitted a supplemental new drug application to the FDA for full approval of the protease inhibitor Prezista (darunavir) as well as an expanded label for use in HIV-1 infected, treatment naïve adults. Prezista received accelerated approval for use in treatment-resistant HIV patients last year based on Phase IIB trials; the sNDA contains data from two Phase III trials.

• VaxGen Inc., of South San Francisco, said it has, with Punk Ziegel and Co., started the process of qualifying its shares of common stock for quotation on the OTC Bulletin Board, and is expected to commence trading by the end of the year under the symbol VXGN. VaxGen and Raven Biotechnologies Inc., also of South San Francisco, have amended the merger agreement between the two companies to clarify that VaxGen's qualification on the OTC Bulletin Board satisfies the closing condition to the proposed merger, requiring that Vaxgen be listed on an approved trading market. (See BioWorld Today, Nov. 14, 2007.)

• Vernalis plc, of London, applied to list 14.7 million shares in order to raise the $5.8 million milestone payment it owes to former holders of Cita NeuroPharmaceuticals Inc., which Vernalis acquired in 2005. The milestone is associated with the successful completion of a Phase II trial with V3381 in neuropathic pain. (See BioWorld Today, Nov. 21, 2005.)

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