Cephalon's Myotrophin, A European Success

With the declaration of successful Phase III results in Europe as well as North America, Cephalon and codevelopment partner Chiron are now poised to take Myotrophin (recombinant insulin-like growth factor-1) to market for the treatment of amyotrophic lateral sclerosis or motorneuron disease.

Answering questions for the press at a symposium on ALS/MND held in Dublin, Ireland, last week, Cephalon senior vice president of clinical research Michael Murphy told the Marketletter that the European trial of Myotrophin had successfully demonstrated the efficacy of the drug in delaying progression and severity of ALS, which was comparable to the earlier North American findings (Marketletter June 19), and that with these data the companies will be looking to file for marketing approval in the USA in the next two months and soon thereafter in Europe, with the hope of having the drug on sale by next summer.

The preliminary analysis of the 183-patient European study showed that Myotrophin taken at 10mg/kg/day doses for nine months reduced both functional severity of the disease and disease progression by 22%, based on the Appel ALS rating scale (a five-measure assessment of disease severity), compared to placebo (p = 0.045). Myotrophin also delayed the onset of disease-related morbidity, as measured by time until a deterioration in respiratory capacity or advanced stage of disease. These findings were statistically significant.