UPDATE 1-Insmed stops supplying Iplex to new patients
Mon Jul 27, 2009 9:20am EDT
July 27 (Reuters) - Biopharmaceutical company Insmed Inc (INSM.O: Quote, Profile, Research, Stock Buzz) said it had stopped supplying new patients with its experimental drug Iplex for treating Lou Gehrig's disease, and it said its limited inventory on hand must be conserved for treating existing patients.
Insmed, which sold its Colorado manufacturing facility to Merck & Co (MRK.N: Quote, Profile, Research, Stock Buzz) earlier this year, said it has no longer the ability to manufacture the drug and it would not initiate further clinical trials with the drug at this time.
Iplex is approved for treating a growth hormone deficiency but is not currently sold for that purpose because of a court order related to patent infringement.
The company is studying Iplex as a potential treatment for muscular dystrophy.
About 70 patients currently receive the drug, including 12 in the United States, the company said. Most of the patients receive Iplex pursuant to a court-ordered extended access program to use the drug in Italy to treat patients with Lou Gehrig's disease, also known as amyotrophic lateral sclerosis, or ALS, the company said.
ALS causes muscles to weaken and eventually deteriorate. It usually develops in people between the ages of 40 and 60.
The company said it has sufficient Iplex inventory to supply these patients for no more than 24 months.
Any agreement with a third party to manufacture Iplex would not result in any production of the drug for at least 12 to 18 months, it said.
If anybody wanted to write a soap opera about ALS and the straws of hope that patients try to grasp, off-label use of FDA-approved drugs, the long and expensive process of getting new indications for FDA-approved drugs, the confusing patent and regulatory situations that can cause availability of drugs in Europe but not in the United States, and the lack of ALS therapies (thus driving patients to try things or be guinea pigs)... Iplex could be the star.