Insmed Inc, a biopharmaceutical company, announced that, effective immediately, the company will cease the supply of Iplex to any new patients. In addition, the company will not initiate further clinical trials with Iplex at this time. The company has determined that its limited inventory on hand must be conserved for the treatment of existing patients.
Following the previously announced sale of Insmed's Boulder, Colorado manufacturing facility to Merck & Co, Inc in March 2009, Insmed no longer has the capability to manufacture Iplex, an extremely complicated drug to produce. Moreover, any agreement with a third party to undertake the manufacture of Iplex, if it was economically feasible and could be arranged, would not result in production of additional quantities of Iplex for at least 12 to 18 months.
There are approximately 70 patients who currently receive Iplex, 12 in the US and the remainder around the rest of the world. Most of the patients receive Iplex pursuant to a court-ordered Extended Access Programme (EAP) for Amyotrophic Lateral Sclerosis (ALS) in Italy. The 12 US patients are being treated for ALS under single patient Investigational New Drug applications approved by the US Food and Drug Administration. The company believes that it has sufficient Iplex inventory to supply these patients for no more than 24 months.
The company intends to analyze the on-going data collected for various indications, including myotonic muscular dystrophy and ALS, and assess the overall Iplex development programme, including possible Iplex manufacturing options with third parties and possible future clinical trials. Initiation of the phase-II clinical trial for ALS patients in the US that had been discussed with FDA earlier this year has been postponed while the company performs this assessment.
Dr Melvin Sharoky, Insmed's chairman, said, "We believe that it is in the best interests of patients who are currently receiving Iplex to ensure that our current limited inventory is conserved in order to maintain their drug supply as long as possible, while allowing the company time to consider its development options."
Insmed is a biopharmaceutical company with unique protein development experience and a proprietary protein platform aimed at niche markets with unmet medical needs.