• 7TM Pharma A/S, of Horsholm, Denmark, selected the Cannabinoid type 1 (CB1) antagonist TM38837 as a preclinical development candidate for obesity and metabolic diseases. The company plans to begin Phase I trials by the end of the year. A Phase II trial is under way with 7TM's lead obesity drug Obinepitide (TM30338), an analogue of two hormones released in connection with food intake, and a Phase I/II trial is ongoing with obesity drug TM30339, a selective Y4 receptor agonist peptide.

• Affymax Inc., of Palo Alto, Calif., affirmed its ongoing collaboration with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for the global development and commercialization of Hematide, Affymax's lead product candidate for the treatment of anemia. Affymax and Takeda are collaborating on the development of Hematide and will co-commercialize the product in the U.S. Affymax is conducting Phase III trials for Hematide to treat anemia in chronic renal failure indications. Takeda is focused on the recently initiated Phase I trial to evaluate Hematide for treatment of chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients. Takeda has been granted an exclusive, royalty-bearing license to develop and commercialize Hematide outside the U.S. Under the terms of the collaboration, Affymax has received $132 million in up-front and milestone payments and $10 million from the sale of equity. Affymax is eligible to receive development and regulatory milestone payments of up to $345 million and commercial milestone payments upon successful commercialization of Hematide of up to $150 million.

• Bioniche Life Sciences Inc., of Bellville, Ontario, said the U.S. Department of Agriculture notified the firm that the latest data for its E. coli O157:H7 cattle vaccine meets the expectation of efficacy standard and is eligible for a conditional license, providing that the company develops a plan that would collect sufficient data to move the product to full licensure. When granted, the conditional license will provide the firm full access to the U.S. market with the restrictions that at least one step in the manufacturing process must be performed in the U.S., and Bioniche will not be permitted to use a trademark name for the vaccine.

• BioSpecifics Technologies Corp., of Lynbrook, N.Y., said it has received full repayment of the loan owed to it by its former CEO Edwin H. Wegman, who died last February. Wegman's estate repaid the loan amount plus accrued interest through the sale of 344,114 shares of BioSpecifics' common stock to certain private investors at the then market price of $12 per share. BioSpecifics received a total amount of $1.26 million from the estate's sale, which includes the loan amount owed of $1.1 million and $152,900 for payment of the exercise of options by the estate. Additionally, BioSpecifics obtained a listing on the OTC Bulletin Board Exchange on Jan. 29.

• CellCyte Genetics Corp., of Kirkland, Wash., became the subject of a class action lawsuit proposed by Finkelstein Thompson LLP, of Washington. The suit, filed in the U.S. District Court for the Western District of Washington, alleges that CellCyte misled investors by publishing false information about the history and experience of CEO Gary A. Reys. The suit said specifically that the firm misrepresented Reys credentials on its website and in SEC filings, particularly regarding Reys educational background, his status as a certified public accountant in Washington state and his prior role in the initial public offerings of various pharmaceutical companies.

• The FDA said it is taking enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout, which is highly toxic and can easily be administered in excessive doses. The agency said it is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events and organ failure. Regulators ordered companies to stop making unapproved colchicine-containing products within 30 days and to stop shipping the products within 180 days. The action is part of the FDA's 2006 initiative to get unapproved products off the U.S. market.

• Harvard Bioscience Inc., of Holliston, Mass., said its board of directors has adopted a shareholder rights plan, which the firm said enhances its ability to protect shareholder interests and ensures that shareholders receive fair treatment in the event of any coercive takeover attempt. In connection with the adoption of the plan, the board declared a dividend distribution of one preferred stock purchase right for each outstanding share of the company's common stock to shareholders.

• Icagen Inc., of Research Triangle Park, N.C., has exercised its put option under a August 2007 deal with Pfizer Inc., of New York, for the private placement of approximately $10 million of Icagen common stock. In the closing of the transaction on Feb. 13, more than 5.8 million shares of common stock will be sold to Pfizer at $1.71 per share, which was the closing bid price of the common stock on Nasdaq the business day prior to the date of the put exercise. Icagen intends to use the net proceeds from this private placement to fund its research and development programs and for general corporate purposes.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., said it received antitrust clearance for its proposed deal with Darmstadt, Germany-based Merck KGaA. Merck licensed worldwide rights to Idera's TLR9 agonists for cancer late last year in a deal worth up to $421 million. The antitrust clearance triggers a $40 million up-front payment to Idera. (See BioWorld Today, Dec. 20, 2007.)

• Meditrina Pharmaceuticals Inc., of Ann Arbor, Mich., has completed a global licensing agreement with AstraZeneca Inc., of London, to develop and market aromatase inhibitors (AI) in combination with the hormones estrogen and progestin to treat endometriosis, a condition associated with pelvic pain. Financial terms were not disclosed. Meditrina said it would use AstraZeneca's Anastrozole in combination with an estrogen and progestin. Under the deal, Meditrina expects to expand its clinical stage product portfolio, which includes Femathina (MPI-674), an AI that is being repurposed to treat several serious women's health conditions, including endometrial thinning in premenopausal women with abnormal uterine bleeding. Femathina recently completed a Phase II clinical trial.

• MethylGene Inc., of Montreal, has exercised its right to opt out of further funding in its collaboration with EnVivo Pharmaceuticals, of Watertown, Mass. EnVivo will continue to research and develop histone deacetylase inhibitors for neurodegenerative disorders such as Huntington's, Alzheimer's and Parkinson's diseases under license from MethylGene. A lead compound has been identified during the collaboration and designated as a clinical candidate by EnVivo. MethylGene will receive royalties on net sales of any approved product, as well as a share of any sublicense income from future partnerships EnVivo may enter into with other companies for neurodegenerative programs.

• Neose Technologies Inc., of Horsham, Pa., received a milestone payment from partner Novo Nordisk A/S, of Bagsvaerd, Denmark. The payment was related to the use of Neose's GlycoPEGylation technology to develop a long-acting version of recombinant Factor VIII for hemophilia A. The amount of the payment was not disclosed. (See BioWorld Today, Nov. 19, 2003.)

• Neurogen Corp., of Branford, Conn., cut about 70 employees as part of a restructuring effort to focus on clinical candidates, including products for insomnia, cough, Parkinson's disease, restless legs syndrome and obesity. The company expects to incur restructuring charges of approximately $1.5 million in the first quarter.

• Senesco Technologies Inc., of New Brunswick, N.J., reported positive findings from preclinical animal studies focused on multiple myeloma that were conducted at the Mayo Clinic and the University of Waterloo. One dosing regimen showed evidence of significant tumor regression in treated mouse models compared to the untreated mice, while the other dose showed a diminished rate of tumor growth along with some regression. The company said the evidence supports filing of an investigational new drug application with the FDA.

• UCB SA, of Brussels, Belgium, said the FDA has agreed to accept a biologics license application for Cimzia for the treatment of adult patients with active rheumatoid arthritis (RA). Cimzia would be the first and only PEGylated anti-TNF biologic therapy available for the treatment of RA. The BLA is based on data from more than 2,367 patients and includes three multicenter, placebo-controlled Phase III trials that were recently presented at the American College of Rheumatology Annual Scientific Meeting. In those studies, Cimzia, given with methotrexate, was shown to be significantly more effective than methotrexate alone for the inhibition of joint damage progression in patients with active RA as early as 24 weeks.

• Upstream Biosciences Inc., of Vancouver, British Columbia, said preclinical data indicated its antimalarial drug candidates demonstrated in vivo efficacy in the nanomolar range. Upstream expanded its early stage pipeline targeting parasitic diseases through the acquisition of Vancouver-based Pacific Pharma Technologies Inc. last year. Shares of Upstream (OTC BB:UPBS) rose 8 cents, or 51.3 percent, to close at 23 cents on Wednesday. (See BioWorld Today, Aug. 28, 2007.)

• Vermillion Inc., of Fremont, Calif., has renewed a long-standing collaboration with Johns Hopkins University on the development of novel biomarkers for disease detection, classification and monitoring of prevalent cancers, including ovarian, breast and prostate. Vermillion will have access to exclusive commercial rights to the discoveries made and will continue to provide financial support, technical assistance and access to its advanced technology platforms, while Johns Hopkins will contribute cancer serum samples and clinical and scientific expertise.

• Viral Genetics Inc., of Azusa, Calif., said it preliminarily identified proteins in its experimental HIV/AIDS drug VGV-1, a therapy based on thymus nuclear protein that is extracted from bovine thymus tissue, which focuses on boosting the immune system to allow the body to fight HIV more efficiently.

• Znomics Inc., of Portland, Ore., launched its Human Disease Library, a subset of its ZeneMark library used to model human diseases in zebrafish.