NN&I - April 2010
Diabetes Watch www.nephronline.comApril 2010 Nephrology News & Issues 17 Transition Therapeutics reaches licensing deal with Eli LillyTransition Therapeutics Inc. said March 3 that it reached an exclusive licensing deal with Eli Lilly for certain diabetes drugs that could yield milestone fees as much as $250 million. The company said it has acquired the rights to a series of pre-clinical compounds from Eli Lilly in the area of diabetes. Transition Therapeutics said it will also have rights to potentially com -mercialize a class of compounds that during the pre-clinical diabetes models showed potential to provide glycemic control and other beneficial effects, including weight loss. Under the terms of agreement, Lilly will receive an up-front payment of $1 million, and will retain the option to re-acquire the rights to the compounds at a later date, Transition Therapeutics said. Lilly retains this option until the end of Phase 2; if Lilly exercises these rights, Transition will receive milestone payments of about $250 million, and up to low-double-digit royalties on sales of products containing such compounds, Transition said. Compiled by Thomas Keating Confidential federal report: Glaxo's Avandia tied to heart problems FDA accepts Biodel's rapid-acting insulin applicationAt year's end, Cambridge, Mass.-based Tolerx Inc. hopes their 10-year, $150 million investment in their lead drug candidate, otelixizumab, will come to fruition, Xconomy.Com reported March 8. The company said it "should get positive results from a pivotal clini -cal trial of a drug with an unorthodox approach for fighting type 1 diabetes." In January, Tolerx completed enroll -ment of all 240 patients in a clinical trial for otelixizumab.GlaxoSmithKline Plc's Avandia drug for diabetics may cause heart attacks and heart failure, The New York Times reported Feb. 20, citing a confidential U.S. govern-ment report. Each month, around 500 heart attacks and 300 cases of heart failure could be avoided if people with diabetes who take the drug were given a rival treatment instead, The Times said, citing a U.S. Food and Drug Administration report. The report recommends removing Avandia from the market. Scientific evidence "simply does not establish that Avandia increas-es" the risk of heart attacks, The Times cited Glaxo as saying in a statement. Biodel Inc said March 1 that U.S. health regulators accepted for review the marketing application for its experimental diabetes drug VIAject, expecting the regulatory action date for its application of Oct. 30. VIAject is a formulation of regular human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin products, the company said. The company, which is trying to get VIAject approved for meal-time use by people with type 1 or type 2 diabetes, had submitted the mar -keting application for the drug on Dec. 30. Tolerx hopes drug will reshape diabetes therapy Diabetes drug stinksliterally"This is a new therapeutic paradigm," Doug Ringler, Tolerx co-founder and chief executive said. "This isn't a cure, but the data we have so far suggest it's the closest thing to a cure we have."The drug is designed to alter the balance between two key classes of immune system cells: the T-effector cells that attack viruses and bacteria and the T-regulatory cells, or "T-regs." GlaxoSmithKline signed on to co-develop otelixizumab in October 2007, a deal that may be worth $760 million. Ubiquitous diabetes drug metformin has an objectionable smell that might explain why many patients stop tak -ing it, U.S. doctors reported in mid- February. In a letter to the Annals of Internal Medicine , Allen Pelletier, MD, of the Medical College of Georgia and col-leagues said the drug smells like fish or dirty socks to some people and this could account for the well-known side effects of the drug: nausea. Pelletier said the problem could be solved by coating the pills so they do not smell or release the odor into the stomach, where it can be burped up. "Patients may report that metform -in nauseates them but do not further elaborate or distinguish this as a vis -ceral reaction to the smell of the medi-cation," Pelletier said. Diabetes_NNI0410_3.indd 17 3/18/10 2:29:01 PM
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