ZURICH (Dow Jones)–Roche Holding AG (ROG.VX) Friday said mid-stage trials of a experimental multiple sclerosis medicine ocrelizumab showed the drug to significantly reduce disease activity in patients with relapsing-remitting multiple sclerosis, raising hopes the medicine could make it to the market and eventually turn into a blockbuster.
Developed by U.S.-based Biogen Idec Inc (BIIB) and Roche unit Genentech, ocrelizumab was recently abandoned in treating patients suffering from rheumatoid arthritis due to an unfavorable risk profile, raising concerns the drug could be discarded in other indications, a step that would have weakened Roche’s pipeline.
Shares in Roche rose after news of the positive trial results, as a potential approval could turn the drug into a blockbuster. At 1348 GMT, the stock was up 2.8%, or CHF3.8, at CHF142.2. Still, Roche’s share price has fallen some 20% so far this year due to a series of setbacks, which have prompted management to launch a restructuring program that will entail job cuts and cost reductions.
Roche said that a 24 week phase II trial showed a substantial reduction of brain lesions and the relapse rate of multiple sclerosis patients. When administered at a dose of 2,000 milligrams, the reduction of brain lesions was 96% and at 89% at a dose of 600 milligram when compared to placebo.
“These efficacy results are amongst the most remarkable seen in a phase II … study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease,” said Professor Ludwig Kappos, lead investigator of the study, from the Department of Neurology, University Hospital Basel, Switzerland.
The study involved 220 patients, comparing ocrelizumab to placebo in patients with relapsing-remitting multiple sclerosis, the most common form of this autoimmune disease that affects around 1.3 million people worldwide.
“We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with multiple sclerosis,” said Hal Barron, Roche’s Chief Medical Officer. “We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development.”
Given these study results, chances for a potential approval are rising and could give Roche a sizable stake in the $10 billion multiple-sclerosis market even though ocrelizumab is administered via infusions, albeit only about twice a year depending on the treatment methodology. Earlier this year, cross-town rival Novartis AG (NVS) received approval to market its multiple sclerosis drug Gilenya, which is administered orally in pill form.
Given this easy regime, Gilenya is expected to reach peak sales of more than $ 3 billion, and could, according to analysts, give Novartis a lead over competitors such as Irish drug maker Elan Corp. PLC (ELN), U.S.-based Biogen Idec Inc. (BIIB) and Germany’s Merck KGaA (MRK.XE), whose drugs have to be administered more often via injections and infusions.
“The data still lacks a few missing pieces, but if it is what it looks like … ocrelizumab has a … strong efficacy profile, especially in relapse rates,” said Vontobel pharma analyst Andrew Weiss.
-By Goran Mijuk, Dow Jones Newswires, +41 43 443 80 47; goran.mijuk@dowjones.com
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