Mylan N.V. (NASDAQ: MYL) shares hit a 52-week low in the session after Mapi Pharma announced midstage results from its multiple sclerosis trial, which it will present at the European Committee for Treatment and Research in Multiple Sclerosis. Specifically, these were Phase 2 results from its study of GA Depot for the treatment of relapsing remitting multiple sclerosis. Mapi Pharma and Mylan are in a strategic partnership to develop GA Depot.
In the extension study, all participants received a 40 mg dose of GA Depot once every four weeks. The number of adverse events was considerably reduced during the second year of treatment compared with the first year.
No immediate post-injection reactions, as are frequently seen with Copaxone and generic glatiramer acetate, were detected. Efficacy results showed there was no significant change in mean Expanded Disability Status Scale score at two years compared with baseline in the per protocol population (PPP). No MRI disease activity was noted in any patients during that period. Some 81.8% of PPP patients showed no evidence of disease activity at two years.
Dr. Shlomo Flechter, head of the MS Clinical Research and Therapy Unit at Assaf Harofeh Medical Center and the Coordinating Primary Investigator of the study extension, commented:
These results suggest that GA Depot is safe, well tolerated and efficacious. The high proportion of patients in the per protocol population that achieved NEDA (84.6% and 81.8%, at one and two years, respectively) is particularly encouraging. If these results will be confirmed in the placebo-controlled Phase III study, GA Depot has the potential to establish a new standard of care for MS drugs.
Shares of Mylan were last seen down about 5% at $33.64, with a consensus analyst price target of $45.76 and a 52-week range of $33.50 to $47.82.