Approval of Diamyd's Diabetes Vaccine Set for 2011

Amy Munday's picture

More diabetes drug treatments will be hitting the markets in 2011. Novo Nordisk's, Victoza, has already been approved by the Food and Drug Administration and Amylin's, Byetta, is looking to be approved in March. Now the Swedish biotech company Diamyd plans to join the diabetes treatment forces once again by releasing more drug treatments and studies concentrating on the development of autoimmune diabetes and its complications.

The diabetes vaccine being developing by Diamyd is not far from being approved now that other diabetes drug treatments are already on the market and under review, such as Byetta. Diamyd is using two different technologies: the first is based on a GAD65 molecule. The molecule was shown to stall the destruction of beta cells connected with Type 1 diabetes. The other technology involves a system to deliver substances directly to nerve cells.

GAD65 being used for therapeutic purposes is licensed from the University of California, Los Angeles. Diamyd's application for a phase III trial in the United States was approved by the U.S. Food and Drug Administration. A parallel phase III trial will be performed in Europe in 2011.

Phase III trials are generally randomly controlled trials based on 300-3,000 diabetic patients. ”The past quarter has been very eventful for Diamyd where the most important have been the completion of enrollment for the European Phase III study and the successful financing of the Company beyond study results,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “The additional capital allows us to negotiate agreements without financial pressure and gives us freedom to choose the best time-point for out-licensing of Diamyd®.”

Written by Amy Munday

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