• Abbott, of Abbott Park, Ill., received marketing authorization from the European Commission for Humira (adalimumab) in moderate-to-severe plaque psoriasis. A regulatory application for Humira in that indication is under review by the FDA. Humira, an inhibitor of tumor necrosis factor, also previously gained approval in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease.

• Ablynx, of Ghent, Belgium, said its TNF-alpha partnership with Wyeth Pharmaceuticals, of Madison, N.J., has been extended for another year. Under the collaboration Wyeth and Ablynx are seeking to discover and develop novel nanobody-based therapeutics against TNF-alpha. Wyeth has exclusive rights to develop and commercialize the anti-TNF-alpha nanobodies developed under the collaboration. As part of the collaboration, Ablynx receives research funding and would be entitled to future milestone payments and royalties upon commercialization. (See BioWorld Today, Nov. 7, 2006.)

• Antisoma plc, of London, opened its new U.S. headquarters in Princeton, N.J. The facility will focus on clinical and regulatory development and will be led by Chris Smyth, vice president of U.S. operations and former head of clinical operations for Antisoma.

• Bavarian Nordic AS, of Kvistgard, Denmark, said it received another milestone payment of $25 million under its contract with the U.S. government to manufacture and deliver 20 million doses of the company's Imvamune smallpox vaccine. The income will be recognized as revenue in the financial statements for 2007. The latest payment brings to date a total of $100 million for the firm in milestone payments under the contract.

• Bioniche Life Sciences Inc., of Belleville, Ontario, received $5 million in federal government financing in support of its vaccine production facility scale-up. The repayable contribution has been provided through the Agri-Opportunities Program of the Canadian Department of Agriculture and Agri-Food and adds to the $10 million repayable loan received earlier this week from the Ministry of Economic Development and Trade's Advanced Manufacturing Investment Strategy for scaling up vaccine production over the next two years to provide capacity of 40 million doses of the E. coli vaccine 0157:H7 vaccine.

• Biopure Corp., of Cambridge, Mass., said it received notice from the Nasdaq Stock Market that its closing bid price had remained below $1 for 30 consecutive business days, and was out of compliance with the minimum bid price requirement for continued listing. The company has six months, or until June 11, 2008, to regain compliance.

• Cell Genesys Inc., of South San Francisco, agreed to sell its lentiviral gene delivery technology to GBP IP LLC, an affiliate of GBP Capital, the majority shareholder in Baltimore-based Lentigen Corp., for $12 million. GBP gains all the intellectual property and previously established licensing agreements relating to the technology, and Cell Genesys will retain rights to use the technology for research and development purposes. GBP assigned management of the portfolio to Lentigen.

• Ceragenix Pharmaceuticals Inc., of Denver, said in vitro data demonstrated its antibiotic CSA-13 rapidly killed multidrug-resistant strains of Pseudomonas aeruginosa and was synergistic with conventional antibiotics. The drug is a synthetic small molecule known as a Ceragenin compound and is designed to bind the cell membranes of certain viruses, fungi and bacteria. The data were published in the Journal of Antimicrobial Chemotherapy.

• Compugen Ltd., of Tel Aviv, Israel, has signed a collaborative discovery and license agreement with Roche AG, of Basel, Switzerland, that will cover the identification and validation of genetic variations for the prediction of response to drugs used for the treatment of rheumatoid arthritis. Under the agreement, Compugen, utilizing its GeneVa platform, will analyze DNA samples and clinical data provided by Roche to identify and validate nonsingle nucleotide polymorphism genetic variations that could serve as biomarkers for the predicted response or nonresponse to selected drugs. Financial terms of the agreement were not disclosed.

• DiaGenic ASA, of Oslo, Norway, said the Michael J. Fox Foundation for Parkinson's Research is funding a DiaGenic study to develop the first blood test for Parkinson's disease: a gene expression signature for the early detection of PD. That involves the identification and validation of a unique gene expression signature for Parkinson's using peripheral blood. The work will be done in conjunction with the Harvard PD Biomarker Study, which is designed for discovery and validation of blood tests for Parkinson's disease.

• Emmaus Medical Inc., of Torrance, Calif., has entered into an exclusive sublicense agreement with Cato BioVentures, of Research Triangle Park, N.C., for the NutreStore brand L-Glutamine. Emmaus will commercialize NutreStore, which is approved by the FDA for use in combination with human growth hormone as a treatment for short bowel syndrome. Emmaus will introduce NutreStore in the spring of 2008.

• Exelixis Inc., of South San Francisco, has submitted a comprehensive data report for investigational new drug candidate XL139 to Bristol-Myers Squibb, of New York, which now has until the end of January to determine if it will select the compound for further development and commercialization as part of a cancer research collaboration with Exelixis. XL139 is a small-molecule inhibitor of the hedgehog signaling pathway. Under terms of the collaboration, which became effective in January, Exelixis is responsible for the identification and preclinical development of small-molecule drug candidates against mutually selected targets. BMS has the right to select up to three IND candidates against three different targets.

• FASgen Inc., of Baltimore, said that preclinical data showed that its C75 compounds were nontoxic in the brain and provided significant neuroprotection for ischemic stroke. In the stroke models tested, C-75 reduced AMP-activated protein kinase levels and resulted in neuroprotection by reduced stroke damage, even when administered poststroke. The findings were published in the Dec. 11, 2007, issue of Stroke.

• Flamel Technologies, of Lyon, France, said it has entered into a collaboration with Merck Serono, of Geneva, to investigate the applicability of Flamel's Medusa technology for the extended release of a therapeutic protein of Merck Serono's portfolio. Under the terms of the agreement, Merck Serono will make an up-front payment of €2 million (US$2.86 million) to Flamel for investigating the therapeutic protein. In addition, Merck Serono will fund R&D efforts to be performed at Flamel. Other financial terms of the agreement were not disclosed.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, said its board of directors has approved the submission of a corporate reorganization to its shareholders for approval. If approved, it would result in shareholders exchanging their existing shares in Forbes for shares in a new company, Newco, which is incorporated in British Columbia. The exchange will result in Forbes becoming a wholly owned subsidiary of Newco. Completion of the transaction, pending the outcome of a shareholder vote and court and regulatory approvals, is expected to occur in the first quarter of 2008.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, said the Cystic Fibrosis Foundation Therapeutics Inc. has selected the biotech's Triolex (HE3286), an orally bioavailable adrenal steroid hormone analogue with anti-inflammatory and insulin sensitizing properties, as a drug candidate for lung inflammation associated with cystic fibrosis under an existing collaboration agreement. Triolex currently is in clinical trials for metabolic disorders and soon will be tested for rheumatoid arthritis. Hollis-Eden also said it expects to receive milestone payments totaling $645,000 from CFFT as a result of reaching certain development milestones under the collaboration agreement.

• Hospira Inc., of Lake Forest, Ill., said the European Commission has authorized it to market Retacrit (epoetin zeta), a follow-on, or biosimilar, erythropoietin, for the treatment of anemia associated with chronic renal failure and chemotherapy. The firm said it will launch the product in various European Union countries, beginning with Germany in early 2008. The EC approved Retacrit, Hospira's first follow-on biologic product, on the basis of strong, compelling safety and efficacy data and compliance with extensive quality, clinical and nonclinical guidelines, the company said. The product is manufactured and packaged in Europe.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., received a non-approvable letter from the FDA for Valstar, related to the chemistry, manufacturing and controls supplement submitted to the new drug application in May. The company previously received an approvable letter in August. According to the company, the Valstar-specific issues that prompted the drug's 2002 withdrawal from the market have been resolved; however, the FDA identified deficiencies during its pre-approval inspection of a third-party manufacturing facility. Indevus expects resolution to those deficiencies within the next several months, after which time it will request another FDA inspection. Valstar is indicated for bladder cancer.

• InSite Vision, of Alameda, Calif., has signed its first international licensing and distribution agreement outside North America for its AzaSite (azithromycin ophthalmic solution) 1 percent with Shin Poong Pharm Co. Ltd., of Seoul, Korea. Shin Poong Pharm will be responsible for regulatory approval and marketing in Korea. Shin Poong will pay InSite up-front and regulatory milestone payments and a double-digit royalty on net sales of AzaSite in Korea, if approved by regulatory authorities. InSite Vision will be responsible for providing manufactured product. Details of the financial terms were not disclosed.

• LifeCycle Pharma A/S, of Horsholm, Denmark, signed a collaboration agreement for an undisclosed pharma firm to use its MeltDose technology to conduct a preclinical feasibility study of a new formulation of one of its product candidates. Financial terms were not disclosed.

• Ligand Pharmaceuticals Inc., of San Diego, received a $1 million milestone payment from partner GlaxoSmithKline plc, of London, due to GSK's submission of a new drug application for Promacta (eltrombopag olamine). The drug is an oral platelet growth factor therapy for the short-term treatment of chronic idiopathic thrombocytopenic purpura. If Promacta is approved, Ligand stands to get another $2 million milestone payment and royalties.

• Nanolymf, of Jerusalem, was spun out from Yissum Ltd., the technology transfer arm of Hebrew University of Jerusalem. The new company will develop a nanotechnology-based, controlled-release delivery platform for lipophilic drugs. Nanolymf, a subsidiary of Rosh Ha'Ayin-based conglomerate Shizim Ltd., has raised $500,000 and is seeking an additional $2 million to fund clinical trials.

• Orion Genomics, of St. Louis, said the results of a genome-wide analysis found more than 50 novel biomarkers, which subsequently were validated in up to 230 independent patient samples, and is the discovery and validation of the most frequent DNA alterations detected in breast cancer to date. The firm said researchers applied a patented microarray-based approach to map tumor associated changes in DNA methylation, alterations that can affect normal gene expression. A single locus associated with the GHSR gene was the most powerful biomarker in the study, with a clinical sensitivity of 90 percent and a specificity of 96 percent for infiltrating ductal breast carcinoma, the company said. In addition to identifying biomarkers that might aid in the detection of breast cancer, Orion said, the research revealed insights into the molecular mechanism of tumor development, which may lead to advances in breast cancer treatment.

• Stealth Biotech Aps, of Copenhagen, Denmark, has filed fundamental patent applications covering methods and products used for blocking specific microRNA:mRNA interactions, a novel approach using antisense molecules that target microRNA binding sites on mRNAs. The filing is part of the firm's plans to target specific microRNA:mRNA interactions for development of novel oligonucleotide-based therapeutics.

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., has sold U.S. and Canadian rights to hepatitis C drug Infergen (interferon alfacon-1) to Three Rivers Pharmaceuticals LLC, of Cranberry Township, Pa. Valeant will receive approximately $70.8 million in cash upon closing, and up to $20.5 million in two noncontingent payments over the following 18 months. Under the terms of the agreement, Three Rivers will be assigned all U.S. and Canadian rights to Infergen and will acquire the remaining Infergen inventory from Valeant. The transaction is expected to close during the first quarter of 2008. Infergen, or consensus interferon, is a bio-optimized, selective and highly potent type 1 interferon alpha originally developed by Amgen Inc. and launched in the U.S. in 1997. It currently is indicated as monotherapy for the treatment of adult patients suffering from chronic hepatitis C viral infections with compensated liver disease and is dosed three times per week.

• Viral Genetics Inc., of Azusa, Calif., entered agreements with the University of Colorado and V-Clip Pharmaceuticals Inc. relating to the exclusive worldwide rights to patent applications and know-how in the fields of diagnosing and treating HIV/AIDS, hepatitis C and herpes. V-Clip was formed specifically for the acquisition of the license. Its shareholders include Viral Genetics and University License Equity Holdings Inc. (the University of Colorado's equity holding arm), along with several individuals. Following the successful completion of certain tests, Viral Genetics will have the right to acquire V-Clip in exchange for shares, options and warrants. Viral Genetics agreed to completely fund those tests for about $600,000, which would require private placement or other sales of company securities, or through grant funding. The agreement includes various royalties and milestone payments to the university upon certain achievements.

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