Insmed, Genentech, and Ipsen/Tercica issue statement about IPLEX for ALS

Tuesday November 18, 2008

The medication IPLEX (mecasermin rinfabate), manufactured by Insmed, has since January 2007 been used on an experimental basis in Italy to treat people with amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), a neurodegenerative disease. On November 10, 2008, Insmed and its partners Genentech and Ipsen/Tercica issued a statement about making IPLEX available to people with ALS in other countries.

The statement says in part: "Genentech, Ipsen/Tercica, and Insmed have been contacted by people living with Amyotrophic Lateral Sclerosis (ALS) and their loved ones seeking access to IPLEX™ . . . We understand the devastation a disease like ALS causes and that there are a lack of available therapies that provide meaningful clinical benefit. Although IPLEX™ has not been rigorously tested in people with ALS, nor received regulatory approval for use in ALS, all the companies involved appreciate the urgency and desperation for new treatments in the ALS community. We are all working diligently to determine how best to respond to that need.

The availability of IPLEX™ is subject to a Court-Ordered Settlement Agreement. On November 8, 2008, Genentech and Ipsen/Tercica signed a letter of intent whereby they have consented to amend the Court-Ordered Settlement Agreement to permit Insmed to supply IPLEX™ in connection with named-patient ALS programs worldwide on a royalty-free basis."

What it all means: Insmed is going to seek approval to use IPLEX in other countries based on the results of the treatment of people with ALS in Italy. The drug won't be free, but Genentech and Ipsen/Tercica won't collect royalties on it. IPLEX is the first drug of any kind to show effectiveness in reducing the symptoms of ALS.

"The best way to get approval is not to need it." Unknown

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