• Alfacell Corp., of Somerset, N.J., reported that its Onconase could be a promising radiation sensitizer for lung cancer treatment. Intae Lee with the University of Pennsylvania, speaking at the American Society for Therapeutic Radiology and Oncology in Los Angeles, said preclinical evidence shows Onconase significantly increased the radiation-induced tumor growth delay of lung tumors in vivo without increases in skin reaction compared to radiation alone. Lee's team of researchers identified noninvasive imaging biomarkers that potentially can be used as a therapeutic predictor for Onconase in non-small-cell lung cancer patients. Onconase is a natural protein isolated from the leopard frog, and is based on Alfacell's ribonuclease (RNase) technology.

• Altea Therapeutics Inc., of Atlanta, achieved sustained and steady basal levels of insulin in patients with Type I diabetes using a small transdermal patch delivering recombinant human insulin, the company reported at the SMi 8th Annual Diabetes Conference held in London. So far, Altea has studied the basal insulin patch in more than 90 healthy subjects or people with Type I diabetes, and results show transdermal delivery of insulin achieved therapeutic levels equivalent to subcutaneous injections of currently marketed long-acting insulins.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., said partner New York-based Pfizer Inc. nominated a second Toll-like receptor 9 agonist compound from the companies' collaboration for future clinical development against cancer. The second-generation drug candidate is expected to complement Pfizer's ongoing clinical programs for PF-3512676, Coley's lead TLR9 agonist. Under the agreement, Pfizer funds the discovery and development of potential next-generation TLR9 agonists, including cancer vaccines, and has exclusive rights to two compounds discovered during the collaboration. Coley retains rights to all other molecules.

• Depomed Inc., of Menlo Park, Calif., and King Pharmaceuticals Inc., of Bristol, Tenn., have terminated their promotion agreement for Glumetza (metformin hydrochloride extended-release tablets), a once-daily extended-release formulation of metformin for patients with Type II diabetes that Depomed developed. King has paid Depomed termination and other fees of approximately $30 million, and Depomed will not pay King a promotion fee for the quarter ending Dec. 31. King will fulfill its Glumetza promotion obligations through the end of 2007.

• Direvo Biotech AG, of Cologne, Germany, said its collaborative industrial enzyme protein engineering project with Danisco AS, of Copenhagen, Denmark, has yielded a significantly improved phytase enzyme. Phytase enzymes release phosphate from phytic acid, which is the main phosphate storage molecule in plants. The project exploited Direvo's high throughput, robotic screening and directed evolution technologies for enzyme optimization.

• Elan Pharmaceuticals Inc., of Dublin, Ireland, has licensed data analysis suite MetaCore from GenGo, of St. Joseph, Mich. MetaCore is designed for functional analysis of biological and chemistry data. Elan will use MetaCore in their neurology and autoimmune programs.

• Evogene Ltd., of Rehovot, Israel, has granted exclusive rights to several of its genes that improve drought-stress tolerance primarily in corn and soybeans to Dupont subsidiary Pioneer Hi-Bred, of Des Moines, Iowa. The financial terms of the agreement were not disclosed. Pioneer will evaluate the licensed genes in its elite corn and soybean germplasm to measure the benefit in its commercial products. The candidate genes were discovered by Evogene's "Athlete" in-silico gene discovery technology.

• Forbes Medi-Tech, of Vancouver, British Columbia, said that on successful completion of current studies under way, the firm expects that a compound from the FM-TP2000 Series targeting diabetes would be confirmed this quarter and a compound from the FM-TP3000 targeting asthma would be selected in early 2008. The FM-TP2000 Series targeting Type II diabetes is based on the neural signal, following a meal, which is known to increase insulin secretion from pancreatic beta cells. The FM-TP3000 Series targeting asthma are inhaled VPAC2 agonists.

• Helsinn Healthcare SA, of Lugano, Switzerland, and partner MGI Pharma Inc., of Minneapolis, have filed a supplemental new drug application for Aloxi (palonosetron hydrochloride) Capsules for treating postoperative nausea and vomiting (PONV). Aloxi Injection is approved by the FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The submission is based on results from two randomized, multicenter, Phase III trials evaluating the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV.

• Integra LifeSciences Holdings Corp., of Plainsboro, N.J., completed its acquisition of IsoTis Inc., of Irvine, Calif., paying $7.25 per share for IsoTis common stock for total consideration of $51 million. All of IsoTis $12.6 million outstanding debt was repaid at closing. The merger, initially signed in August, adds IsoTis's bone matrix allograft development to Integra's medical device offerings. Thomas Weisel Partners LLC acted as advisor to IsoTis, while Latham & Watkins acted as legal counsel. Willkie Farr & Gallagher LLP served as legal counsel for Integra. (See BioWorld Today, Aug. 8, 2007.)

• Lev Pharmaceuticals Inc., of New York, amended its pending biologics license application for Cinryze (C1 inhibitor) for hereditary angioedema to include data from a pivotal Phase III trial demonstrating the use of Cinryze as a prophylactic for HAE. Lev initially filed the BLA in late July, seeking approval of Cinryze in the acute treatment of HAE, and the agency accepted the filing early this month. The submission of the prophylactic data will allow the FDA to complete a comprehensive review for both acute and prophylactic indications without affecting the priority review timeline. Pending FDA approval, Cinryze would hit the market in 2008. (See BioWorld Today, Aug. 1, 2007.)

• Medarex Inc., of Princeton, N.J., and Ono Pharmaceutical Co. Ltd., of Osaka, Japan, said the FDA has allowed the investigational new drug application for MDX-1106 (ONO-4538), a fully human anti-PD-1 antibody being investigated for the treatment of chronic viral infections, with the first trial to target hepatitis C. MDX-1106 was developed under the May 2005 research collaboration, and is already in a Phase I study in patients with recurrent or treatment- refractory cancer.

• Neoprobe Corp., of Dublin, Ohio, said it recently met with the FDA to review its successful Phase II study of Lymphoseek, a radioactive tracing agent for use in tumor detection, and is in concurrence with the agency for proposed Phase III studies. Those trials will evaluate concordance of the targeting of lymph nodes with Lymphoseek compared to a blue dye commonly used in lymphatic mapping procedures. The company awaits final clearance from the FDA to begin Phase III testing.

• Nycomed, of Zurick, Switzerland, has expanded its dermatology franchise in the U.S. by signing a definitive agreement to purchase Bradley Pharmaceuticals Inc., of Fairfield, N.J., for $20 per share, or $346 million. The purchase brings to Nycomed Bradley brand names such as Doak Dermatologics, in dermatology and podiatry, Kenwood Therapeutics, with products in the OB/GYN, respiratory and internal medicine markets, and A. Aarons, which markets generic versions of Doak and Kenwood therapies. The transaction has been approved by the Bradley board of directors, and is conditioned on approval by company shareholders, regulatory approvals and other customary closing conditions. Nycomed said it will fund the acquisition through "strong generation of excess cash in 2007," plus commitments by current investors and credit facilities. The acquisition is expected to be completed in the first quarter of 2008. The privately owned Nycomed said it intends to delist Bradley.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer HealthCare Pharmaceuticals, of Wayne, N.J., said the European Commission granted marketing authorization to Nexavar (sorafenib) tablets in patients with hepatocellular carcinoma. Nexavar, an oral multikinase inhibitor that has demonstrated improvements in overall patient survival, is the first systemic therapy for HCC. Additional regulatory filings are under review in other countries, including the U.S. Nexavar previously gained approval in more than 60 countries for advanced kidney cancer.

• Pharmos Corp., of Iselin, N.J., is continuing its restructuring by eliminating 15 of the 23 workers in its Israeli subsidiary, Pharmos Ltd. The company said it did not expect a material change in operations. The company also said it will consider other means of financing continuing programs, such as finding new investors to finance Pharmos Ltd. as an independent entity. Haim Aviv, founder of Pharmos, will lead the efforts. The company said the restructuring will have no effect on its late-stage clinical program with dextofisopam, which is in Phase IIb testing in the U.S. as a treatment for irritable bowel syndrome.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said it has received allowance of its U.S. patent application, protecting therapeutic agents based on a novel radiodense analogue of its lead therapeutic product PV-10, from the U.S. Patent and Trademark Office. The pending patent covers therapeutic agents, called radiosensitizers, that are used in conjunction with radiation therapy to improve the efficiency and specificity of radiation for oncology.

• Quest Group International Inc., of Los Angeles, has changed its name to NuRx Pharmaceuticals Inc. The company said the new name reflects its focus on development of a large portfolio of retinoid and rexinoid compounds that target nuclear receptors for a broad range of needs, with an initial focus in oncology.

• Rosetta Genomics Ltd., of Rehovot, Israel, said it successfully completed the prevalidation phase for its first diagnostic test. Using a single microRNA, the test is designed to differentiate squamous from nonsquamous lung cancer with high sensitivity and specificity. Rosetta's diagnostic tests are undergoing validation testing, and it expects three diagnostic tests to be launched in 2008, including a test for cancer of unknown primary, lung cancer vs. mesothelioma, and the squamous vs. nonsquamous lung cancer test which recently passed the prevalidation phase.

• Sapphire Therapeutics Inc., of Bridgewater, N.J., has licensed a discovery-stage ghrelin antagonist program from Novo Nordisk A/S, of Bagsvaerd, Denmark. Ghrelin receptor antagonists are a new therapeutic target for treating obesity. Those potential drugs were identified using Novo's computer model of the ghrelin receptor and have shown good in vivo proof-of-concept data, Sapphire said. No financial terms were disclosed.

• Summit Corp. plc, of Oxford, UK, signed a $450,000 deal with a large undisclosed pharmaceutical company for use of its zebrafish technology in drug discovery and development. The pharma firm will use Summit's platform to assess a significant number of compounds for safety and toxicity effects in a range of organs that are conserved between the zebrafish and humans, including the heart, liver, brain and gut. This extended pilot deal follows the conclusion of an earlier validation study conducted between the two companies.