Insmed, a biopharmaceutical 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.
Insmed has determined that its limited inventory on hand must be conserved for the treatment of existing patients. Following the previously announced sale of its Colorado manufacturing facility to Merck & Co, in March 2009, Insmed no longer has the capability to manufacture IPLEX.
Moreover, any agreement with a third party to undertake the manufacture of IPLEX, would not result in production of additional quantities of IPLEX for at least 12 to 18 months.
Reportedly, there are approximately 70 patients who currently receive IPLEX, 12 in the US and the remainder around the rest of the world. The company believes that it has sufficient IPLEX inventory to supply these patients for no more than 24 months.
Insmed intends to analyze the on-going data collected for various indications, including myotonic muscular dystrophy and ALS, and assess the overall IPLEX development program. The 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.
Melvin Sharoky, chairman of Insmed, said: We believe that it is in the best interests of patients who are currently receiving IPLEX(TM) 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.