Merck KGaA, the German drug maker, said it would seek regulatory approval mid-year for a new oral pill for multiple sclerosis following positive phase III results released Friday.
All current treatments for multiple sclerosis (MS), including Biogen Idec's Avonex and Tysabri, are given by injections, which leaves them commercially vulnerable to an oral MS drug, if one can be approved that is equally or more effective with an acceptable safety profile.
In addition to Merck KGaA, Novartis (NVS - Get Report) is also developing a pill for MS, with positive phase III data released in December. Biogen Idec, too, has its own pill for MS in phase III trials.Merck Serono, a divison of Merck KGaA, said Friday that a low-dose of its drug, cladribine, reduced the annual relapse rate in MS patients by 58% compared to placebo. A higher dose of cladribine reduced the MS relapse rate by 55% compared to a placebo. These reductions in relapse rates are generally superior to those seen by most of the injectable MS drugs currently on the market with the exception of Tysabri, although cladribine has not been tested head-to-head against any of these drugs. More data needs to be released on cladribine, especially in regard to its safety profile, before determining just how significant a player it might be in the MS market. However, just the threat of another competing MS drug, especially one with the convenience of oral dosing, was enough to send Biogen Idec shares lower.