• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted GeneDesign Inc., of Osaka, Japan, a nonexclusive license to provide RNAi research products and services under the Kreutzer-Limmer patent family. Those patents cover small interfering RNAis and their use to mediate RNAi in mammalian cells. Financial terms were not disclosed.

• Bavarian Nordic A/S, of Kvistgaard, Denmark, said the U.S. government extended the request-for-proposal contract that was awarded in 2004 in a deal valued at $15 million. Within the scope of the new contract period, which extends until 2010, Bavarian Nordic will initiate a larger Phase II study of Imvamune in people diagnosed with atopic dermatitis. Atopic dermatitis patients are potentially one of the largest risk groups associated with traditional smallpox vaccines, and the company said the contract extension furthers its efforts to develop a third-generation vaccine. Earlier this year, Bavarian Nordic reported that the Department of Health and Human Services decided to purchase 20 million doses of Imvamune for the strategic national stockpile. (See BioWorld Today, April 17, 2007.)

• Caliper Life Sciences Inc., of Hopkinton, Mass., said the National Institute of Environmental Health Services awarded the company a contract valued at up to $7 million, covering a period of up to 10 years NIEHS' option, under which Caliper's drug discovery services arm, Xenogen Biosciences, will provide genetically modified mouse models for research purposes. The NIEHS will use the mouse models, including transgenic and gene knockout, to conduct research aimed at identifying and potentially preventing hazardous conditions and exposure in humans.

• Callisto Pharmaceuticals Inc., of New York, said the firm has determined a strategic initiative for Guanilib, a guanylate cyclase C receptor, which includes plans to file an investigational new drug application in the first quarter of 2008 for a Phase I study. The company also decided to shift the immediate focus of Guanilib from gastro-inflammatory diseases to chronic constipation and irritable bowel syndrome with constipation, and anticipates devoting at least half of its available funds for Guanilib development.

• Cangene Corp., of Toronto, said it is consolidating research and development activities relating to its production of plasma-derived and recombinant therapeutic proteins from its Mississauga location to its Winnipeg location. The move will result in a 4 percent staff reduction and net operating savings of approximately $1.5 million annually.

• Duska Therapeutics Inc., of Bala Cynwyd, Pa., named James Kuo CEO. Kuo, who also serves as chairman, previously has headed up several biotech companies and worked as a venture capitalist. Duska's work focuses on developing drugs for cardiovascular diseases by modulating the P2 receptor in the heart and lungs.

• Genzyme Corp., of Cambridge, Mass., received a warning letter from the FDA about manufacturing violations at the firm's plant in Lyon, France, where the company's kidney transplant product, Thymoglobulin, is made. The FDA told the firm that inspectors in June documented significant deviations from current good manufacturing practices. On several occasions, Genzyme used components and intermediates that failed in-process limits for bioburden and presence of pathogenic microorganisms. The firm also failed to control the purified water system used in manufacturing Thymoglobulin. Failure to correct the violations, the FDA warned, could result in license suspension or revocation.

• ImClone Systems Inc., of New York, and partner Bristol-Myers Squibb Co., also of New York, said the FDA approved a supplemental biologics license application to expand the product labeling for Erbitux (cetuximab) to include overall survival data as a single agent in epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer patients following failure of both irinotecan- and oxaliplatin-based regimens. Approval was based on data from a 572-patient Phase III study showing prolonged overall survival in patients receiving Erbitux plus best supportive care vs. best supportive care alone. Though the FDA's decision was expected, analyst Han Li, of Houston-based Stanford Group Co., wrote in a research note that, with the sBLA approval, he expects "Erbitux sales to reaccelerate in 2008 - 2009." Li maintained a "buy" rating and a $60 price target. Shares of ImClone (NASDAQ:IMCL) gained $1.43 Wednesday to close at $43.46.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it has been awarded a multiyear Phase II Small Business Innovation Research grant by the National Institutes of Health for up to $1.5 million to design oligonucleotide drugs that can exploit the RNA interference (RNAi) antisense mechanism for disease treatment. The multiyear grant will fund research by Isis to improve the stability and tissue distribution of RNAi drugs. Much of the work will focus on optimizing the chemical properties of single-stranded oligonucleotides that trigger the RNAi pathway. The grant also funds the discovery of RNAi-based drugs.

• MacroChem Corp., of Wellesley Hills, Mass., exercised its option to acquire exclusive, worldwide rights to pexiganan, a small peptide anti-infective, in mild diabetic foot infection from Plymouth Meeting, Pa.-based Genaera Corp. Under the terms, MacroChem will pay Genaera an initial $1 million fee through Feb. 1, 2008, and up to $7 million in clinical and regulatory milestones. Upon approval, Genaera would be entitled to up to $35 million in sales-based milestones and a 10 percent royalty. MacroChem said the program complements its lead product candidate, EnoNail, since both primarily would be prescribed by podiatrists. To reach other specialists and primary care physicians, the company anticipates seeking a marketing partner. Genaera completed Phase III trials of pexiganan in the late 1990s, two of which reached the primary endpoint. A third trial, however, missed its specified endpoint and difficulties with chemistry, manufacturing and controls precluded the drug's approval. MacroChem believes that the necessary improvements have been made in peptide manufacturing, and the company plans to implement a program to address the issues and begin discussions with the FDA to determine a clinical development path.

• Metabasis Therapeutics Inc., of San Diego, said the European Commission granted orphan designation to MB07133, a HepDirect prodrug of cytarabine monophosphate, for hepatocellular carcinoma. That status provides regulatory assistance and guarantees up to 10 years of marketing exclusivity upon approval. Shares of Metabasis (NASDAQ:MBRX) gained 6 percent on the news to close at $3.01, up 17 cents.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., completed the purchase of a commercial-scale radiopharmaceutical manufacturing facility in Denton, Texas, from NeoRx Manufacturing Group Inc., a wholly owned subsidiary of South San Francisco-based Poniard Pharmaceuticals Inc. The $3 million transaction allows Molecular Insight to expand its manufacturing capabilities. The firm intends to use a portion of the facility to produce Azedra, its lead targeted molecular radiotherapeutic candidate for neuroendocrine cancer, and anticipates that the facility will be ready for the potential launch of Zemvia, a molecular imaging candidate for detecting cardiac ischemia.

• Monogram Biosciences Inc., of South San Francisco, agreed to an exclusive partnership with Lab21, a Hampshire, UK-based provider of health and environmental diagnostics, under which Lab21 will provide operations and logistics services for Monogram's Trofile assay, a companion diagnostic to New York-based Pfizer Inc.'s recently approved HIV inhibitor, Celsentri. Monogram will use Lab21's capabilities to ensure that samples are properly collected and transported to Monogram's laboratory for testing and that results are reported efficiently. Financial terms were not disclosed.

• Morphotek Inc., of Exton, Pa., said it has received $2.7 million in funding from the National Institute of Allergy and Infectious Diseases to support the preclinical development of fully human therapeutic monoclonal antibodies (mAbs) capable of neutralizing the toxic effects of Staphylococcal enterotoxin B (SEB) in vivo. The development project is a defense initiative in the fight against biowarfare agents. The funding will be used to develop potent therapeutic mAbs capable of suppressing the toxic effects of SEB with the goal of demonstrating proof of concept in clinical trials. By employing Morphotek's proprietary human Morphodoma technology, the company seeks to further optimize the therapeutic activity of existing anti-SEB lead mAbs and then advance these into proof-of-concept studies.

• Nanobac Pharmaceuticals Inc. and Calgenex Corp., both of Tampa, Fla., have signed an agreement for treatments used in atherosclerosis, prostatitis, and other pathologic calcification diseases. Under the deal, Calgenex has granted Nanobac an option to access its drug delivery technology that includes a novel combination of bisphosphonate and silicic acid. Nanobac is investigating the use of bisphosphonates in combination with other approved compounds for the treatment diseases associated with soft tissue calcification, including atherosclerosis and prostatitis.

• Orexo AB, of Stockholm, Sweden, said it is developing a new, oral drug delivery technology using bioceramics developed by its Swedish partner Doxa AB. This delivery technology will provide a controlled release of the active substance and also has the potential to lessen the risk of abuse of the pain medication. The technology offers unique advantages and will provide for a new innovative platform for opioids, among others. Studies performed by Orexo indicated that the new drug delivery technology might offer considerable potential in this area of unmet need. Orexo also is developing a formulation of OX23, a highly potent substance for the treatment of moderate to severe acute pain. OX23 will be based on Orexo's sublingual tablet technology, combining fast-dissolving properties with rapid onset of action and predictable effect.

• Origen Therapeutics, of Burlingame, Calif., received a $2 million Advanced Technology Program grant from the National Institute of Standards and Technology. That three-year grant will help fund development of a new method for discovering and producing human polyclonal antibodies against human disease by inserting complex genetic modifications into the chicken genome, which will enable the chickens to deposit large amounts of the therapeutic antibodies into their eggs. Origen's first objective under the program will be to create polyclonal antibodies to treat antibiotic-resistant infections, such as Staphylococcus aureus infections in intensive care units.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., received a $500,000 equipment loan from the Bank of Ann Arbor to support its cGMP pharmaceutical production facility for production of its lead product, Coprexa (oral tetrathiomolybdate) for neurologically-presenting Wilson's disease, and other potential drug candidates. The specialty pharmaceutical firm focuses its development efforts on late-stage products for neurologic and fibrotic diseases.

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