• Alteon Inc., of Parsippany, N.J., said one of its collaborators at the Baker Heart Research Institute in Melbourne, Australia, was awarded a grant from the Juvenile Diabetes Research Foundation to help fund a multinational Phase II study of alagebrium's effect on renal function in Type I diabetics and microalbuminuria. An A.G.E. crosslink breaker, Alteon's lead compound will be tested for its ability to reverse kidney damage caused by diabetes, and to reverse the protein excretion which is characteristic of diabetic nephropathy. The study will include 80 patients who will receive placebo and an ACE inhibitor during an eight-week, single-blind, run-in period. This will be followed by 24 weeks of double-blind treatment with either placebo or alagebrium in combination with an ACE inhibitor. Changes in albumin excretion rate will be the primary endpoint of the study. The study is expected to begin next quarter.

• Amgen Inc., of Thousand Oaks, Calif., said an administrative law judge at the U.S. International Trade Commission issued a summary determination that Basel, Switzerland-based F. Hoffmann-La Roche Ltd.'s importation and use of peg-EPO in the U.S. to date are subject to a clinical trial exemption to patent infringement. The judge made no determination on the merits of Amgen's claim that Roche's future importation and sale of peg-EPO infringe on Amgen's patents, and the ruling had no impact on Amgen's pending patent infringement lawsuit filed last fall against Roche in federal court, Amgen said. That suit alleges that Roche's peg-EPO product violates six of Amgen's U.S. patents while providing no additional clinical or patient benefit over Epogen (epoetin alfa) and Aranesp (darbepoetin alfa). (See BioWorld Today, Nov. 10, 2005.)

• Antigenics Inc., of New York, expanded its license and supply agreements with GlaxoSmithKline Biologicals, a vaccine division of London-based GlaxoSmithKline plc, for the use of its QS-21 Stimulon adjuvant. A number of GSK's vaccine candidates are formulated from adjuvant systems containing Antigenics' QS-21. Under the terms, GSK agreed to purchase a percentage of its QS-21 supply requirements from Antigenics through 2104, and also will gain access to Antigenics' manufacturing technologies. In exchange, GSK will make payments contingent upon milestone achievements, and will pay Antigenics royalties on net sales for a period of at least 10 years after the first commercial sale.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said its partner, Deerfield, Ill.-based Astellas Pharma US Inc., a division of Astellas Pharma Inc., of Tokyo, agreed to fund 100 percent of the costs associated with resubmitting the new drug application for RSD1235 in atrial fibrillation, including fees to engage any external consultants. Astellas also agreed to modify the timing of its $10 million milestone payment to Cardiome, which previously was expected upon FDA acceptance of the NDA for review, to be payable on the date of NDA resubmission. In late May, the companies reported receiving a refusal-to-file letter from the FDA due to "inconsistencies and omissions in the database." Astellas, which gained exclusive rights to develop and commercialize RSD1235 in North America when it acquired Cardiome's previous partner, Fujisawa Healthcare Inc., was responsible for handling the regulatory submissions. (See BioWorld Today, of June 1, 2006.)

• Cellegy Pharmaceuticals Inc., of Huntingdon Valley, Pa., received an approvable letter from the FDA for Cellegesic (nitroglycerin ointment) to treat anal fissures. Final approval is to be granted once Cellegy conducts another clinical trial to demonstrate efficacy at a statistically significant level. The agency said the results of three previous trials did not provide substantial evidence that the drug is effective. Cellegesic was the subject of a not approvable letter in December 2004. The company submitted new analyses in April 2005, and the FDA's Cardio-Renal Advisory Committee voted in April, with six members recommending approval and six members recommending the drug be approvable pending another study. Cellegy is considering its options and will scheduled a meeting with the FDA. The company's stock (OTC BB:CLGY) fell 20 cents Monday, or 30.7 percent, to close at 45 cents. (See BioWorld Today, Dec. 28, 2004.)

• HepaLife Technologies Inc., of Boston, through a wholly owned subsidiary, entered an exclusive, worldwide license agreement with Michigan State University to develop cell-culture-based flu vaccines against influenza, including the H5N1 virus. The agreement gives HepaLife rights to five patents, in exchange for undisclosed milestone payments to MSU, as well as royalties.

• Mendel Biotechnology Inc., of Hayward, Calif., expanded its partnership with Monsanto Co., of St. Louis, and extended it through 2011. Monsanto will continue to commercialize technologies developed by Mendel, and the companies will initiate a systems biology program to develop an integrated framework for predictive control of plant gene expression. Should resulting products be commercialized, Mendel would receive milestone and royalty payments. This new partnership extends a relationship that dates to 1997. Financial terms were not disclosed.

• Quatrx Pharmaceuticals Co., of Ann Arbor, Mich., withdrew plans for an initial public offering, citing unfavorable market conditions. The company filed for an IPO in February, and in April, set a price of $11 to $13 for 6 million shares that would have raised $78 million at the high end. Its most advanced product, ospemifene, is in Phase III trials in vaginal atrophy in postmenopausal women. As of Dec. 31, the company had cash, cash equivalents and working capital of $39.3 million.

• Translational Genomics Research Institute (TGen), of Phoenix, and GE Healthcare, a division of the General Electric Co., of Fairfield, N.J., signed an alliance to apply advanced cellular genomics technologies and strategies to improve and accelerate new drug discovery and development. The collaboration will add GE's IN Cell Analyzer imaging systems to TGen's high-throughput cellular analysis research programs to identify and characterize cancer-associated genes for the development of targeted medicines.

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