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TMCNet: BioWorld Today August 3, 2009

[July 31, 2009]

BioWorld Today August 3, 2009

(BioWorld Today Via Acquire Media NewsEdge) , of Montreal, said it will seek court protection under the Companies' Creditors Act in Canada, after its board concluded that current cash on hand would not allow it to meet obligations. No restructuring plan has yet been determined. In the past two weeks, the firm terminated a Phase III study of octreotide acetate in acromegaly and cut two senior executive positions, including President and CEO Philippe Calais, in ongoing efforts to save money. Ambrilia had $3.2 million in cash as of March 31.


• Auxilium Pharmaceuticals Inc., of Malvern, Pa., said the FDA's Arthritis Advisory Committee confirmed it will review the application for Xiaflex Sept. 16, though the FDA has not updated the PDUFA date of Aug. 28. Xiaflex (collagenase clostridium histolyticum) is an orphan-designed biologic aimed at treating Dupuytren's contracture. The company initially disclosed the panel meeting in June. (See BioWorld Today, June 19, 2009.) • AVEO Pharmaceuticals Inc., of Cambridge, Mass., reported preclinical data showing that tivozanib (AV-951), an oral, triple VEGF receptor inhibitor, exhibited anti-angiogenic and antitumor activity in the company's in vivo lung cancer models. Specifically, treatment with tivozanib resulted in complete tumor growth inhibition or tumor regression in lung tumors driven by EGFR or KRAS mutations. Data were presented at the World Conference on Lung Cancer in San Francisco.

• BioInvent International AB, of Lund, Sweden, signed a license deal with Osaka, Japan-based Mitsubishi Tanabe Pharma Corp. for the development of antibodies for up to five different targets using its n-CoDeR library. Under the terms, Mitsubishi will gain access to BioInvent's platform in exchange for an undisclosed up-front access fee, plus annual maintenance fees, royalties on any sales and success-based milestone payments.

• Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said the FDA approved Onglyza (saxagliptin), a once-daily, dipeptidyl peptidase-4 inhibitor, to treat Type II diabetes in adults. Approval came a day after the product's July 30 PDUFA date. Onglyza will compete against Januvia (sitagliptin), a DPP-4 inhibitor marketed by Whitehouse Station, N.J.-based Merck & Co. Inc.

• Cangene Corp., of Toronto, withdrew its marketing authorization application for WinRho SDF (Rho Immune Globulin [human] for injection) in 16 European Union countries and will cease marketing the product in EU countries where authorizations previously were obtained. The company said those decisions were based on the challenges and cost of gaining regulatory approval in the remaining countries, as well as a re-evaluation of its marketing strategy and competitive landscape.

• DxS Ltd., of Manchester, UK, is working with London-based AstraZeneca plc to develop a companion diagnostic for use with Iressa (gefitinib) in non-small-cell lung cancer. DxS' clinical diagnostic, TheraScreen: EGFR29 Mutation Kit, will be used to test the mutation status of a patient's EGFR oncogene to identify their eligibility for Iressa treatment. Terms of the collaboration were not disclosed.

• Genzyme Corp., of Cambridge, Mass., said the FDA will re-inspect the company's Allston Landing manufacturing facility. The inspection is intended to verify that all corrective and preventative actions identified in a February warning letter were implemented. The FDA also will review Genzyme's remediation efforts related to the recent identification of a virus, which caused the firm to temporarily halt production. (See BioWorld Today, June 17, 2009.) • Ligand Pharmaceuticals Inc., of San Diego, said it mutually terminated its collaboration and license agreement with NV Organon, of Oss, the Netherlands, which Ligand assumed in its late 2008 acquisition of Pharmacopeia Inc., of Princeton, N.J. The deal between Pharmacopeia and Organon had centered on discovering and developing drugs for neuroscience and immunology indications. Organon will continue to fund research through a wind-down period ending Dec. 31, and Ligand may receive up to several million dollars in milestones during that period. Ligand also is entitled to future royalties and milestones if Organon advanced candidates discovered in the collaboration through development. Organon was acquired by Kenilworth, N.J.-based Schering-Plough Corp.in 2007. Ligand has separate agreements with Schering-Plough for drug candidates in Phase I and Phase II studies, which are not affected by ending the Organon deal.

• SemBioSys Genetics Inc., of Calgary, Alberta, completed its transaction with its wholly owned subsidiary, Botaneco Specialty Ingredients Inc. and Avrio Ventures Ltd. Partnership. The deal was designed to simplify Botaneco's capital structure and remove Botaneco's assets and liabilities from SemBioSys' balance sheet.

• XOMA Ltd., of Berkeley, Calif., received a $1.7 million subcontract by SRI International, of Menlo Park, Calif., to produce antibody drugs against the virus that causes severe acute respiratory syndrome. The project is funded under a 2006 prime contract between SRI and the National Institute of Allergy and Infectious Diseases. XOMA, which will evaluate several antibodies for growth, productivity, manufacturability and performance in bioreactors, could receive additional awards under the five-year contract.

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