Italian Health Ministry Taps Insmed Drug for ALS

Insmed Incorporated, based in Richmond, Virginia, has been requested by the Italian Ministry of Health, to make its drug, IPLEXTM (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.

The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 pertaining to the treatment of ALS, Insmed will be able to provide IPLEX to physicians in Italy. IPLEX will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian Health
Authorities.

ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system. In animal models and cell culture systems IGF-1 protects motor neurons and promotes muscle and nerve regeneration.

“We are very pleased that the Italian ministry has approached us to help in treating this devastating disease,” said Geoffrey Allan, President and CEO of Insmed. “We greatly appreciate the fact that Cephalon has collaborated with us in this effort. We hope that data collected from this expanded access program will be useful for the further clinical development of IPLEX for this indication,” he added.

In Italy, there are an estimated 1000 new cases of ALS per year. The Ministry of Health has tried for several years to provide IGF-1 to these patients and in doing so has contacted several pharmaceutical companies worldwide.

“We are very pleased that Insmed responded to our request and are willing to provide IPLEX,” said Carlo Tomino of the Italian Ministry of Health/AIFA.