ITALY ASKS COMPANY TO PROVIDE DRUG TO TREAT ALS

The Italian Ministry of Health has asked Insmed to make its drug Iplex available to physicians in Italy to treat patients with amyotrophic lateral sclerosis (ALS), a neurodegenerative disorder.

The request comes as a result of several Italian court rulings ordering the Italian National Health System to provide Iplex (rhIGF-I/rhIGFBP-3) to specific ALS patients who have petitioned the court. Through an agreement with Cephalon, which holds European patent rights to IGF-I for treating ALS, Insmed will be able to provide Iplex to physicians in Italy. The drug will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian health authorities.

"We are very pleased that the Italian ministry has approached us to help in treating this devastating disease," Geoffrey Allan, president and CEO of Insmed, said. "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."

In Italy, there are an estimated 1,000 new cases of ALS every year, according to Insmed. The Ministry of Health has tried for several years to provide IGF-1 to ALS patients and has contacted several pharmaceutical companies.

Iplex is approved in the U.S. as a once-daily treatment for children with short stature associated with severe primary IGF-I deficiency. The drug, launched in the U.S. in 2006, is also being investigated for various other indications, including severe insulin resistance, myotonic muscular dystrophy and HIV-associated adipose redistribution syndrome.