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What Is The Status of Biogen Idec’s Orphan Drug Dexpramipexole For ALS?

January 5, 2013

       Biogen Idec announces on January 3, 2013, that data for the Phase III (EMPOWER) clinical trial of orphan drug Dexpramipexole for the treatment of Amyotrophic Lateral Sclerosis (ALS) does not meet its primary endpoint.

Biogen Idec in a Press Release says that the primary endpoint, “a joint rank analysis of function and survival (was not meet), and no efficacy was seen in the individual components of function or survival. The trial also failed to show efficacy in its key secondary endpoints …”. As a result, Biogen Idec will discontinue development of Dexpramipexole for ALS. Dexpramipexole was given FDA Orphan Drug Designation (ODD) on October 11, 2007. Biogen Idec has a license agreement, worth about $345 million, with Knopp Neurosciences for both the development and commercialization of the drug.

The only drug on the market for ALS is Sanofi’s Rilutek.

Biogen Idec has several programs currently underway for ALS which will continue :

– Research collaboration with Duke University & HudsonAlpha Institute to sequence ALS genomes over 5 years

– 1st-of-its-kind Research Consortium to identify ALS drug targets, with projects underway at Columbia, Harvard, Rockefeller University, and at Yale University.

The Internet Buzz on the failure of this orphan drug for ALS :

1)  The New York Times January 3, 2013, titled, “Biogen Idec Gives Up on Drug for Lou Gehrig’s Disease”

2) Forbes.com January 3, 2013 article titled, “Biogen Idec ALS Drug Fails”

3) Bloomberg.com January 3, 2013 article titled, “Biogen Sinks as ALS Drug Fails to Show Efficacy in Trial”

4) BostonHerald.com January 4, 2013 article titled, “Setback for Biogen – Disappointment as drug for ALS fails crucial final tests”

5) PharmaTimes.com January 3, 2013 article titled, “Biogen Idec’s ALS drug binned after failed trial”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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