Tuesday, November 25, 2008

Drug used by ALS patients gets closer to distribution
By Elizabeth SimpsonThe Virginian-Pilot© November 26, 2008
A drug that some patients with a degenerative nerve disease have been clamoring to get for more than a year has moved a step closer to being freed for distribution.
Iplex, made by Richmond-based company Insmed, had been used in an off-label fashion by some patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease.
But it was taken off the U.S. market in 2007 when California-based company Genentech sued Insmed, saying it used a component licensed exclusively to another drug company, Tercica.
That resulted in an outcry from patients who were using Iplex and others who wanted to. People with ALS progressively lose control of their voluntary muscles, such as swallowing and breathing, and eventually become paralyzed. Life expectancy after diagnosis is usually two to seven years.
In response to patients' concerns, Genentech, Tercica and Insmed signed a letter of intent earlier this month freeing Insmed to supply the drug if it receives regulatory permission from the U.S. Food and Drug Administration.
The drug still has not been through rigorous testing, nor has it been approved by the FDA for use by ALS patients. People who want the drug are hopeful that will be the next step. A phone call to Insmed for comment on such progress was not returned Tuesday.
Attorneys at the local office of the Richmond-based Williams Mullen recently got involved with the effort to free the drug for distribution after hearing that Josh Thompson, a Virginia Beach resident and son of prominent developer Bruce Thompson, wanted access to the drug.
Elizabeth Simpson, (757) 446-2635, elizabeth.simpson@pilotonline.com

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