Approval for Movectro a game changer for MS: Datamonitor

Russia’s approval this week of Merck Serono’s Movectro (oral cladribine) marks a major shift towards new oral treatments for multiple sclerosis (MS), according to industry analysts Datamonitor.

Movectro is the first orally administered product approved to treat relapse-remitting MS (RRMS) in a market which has been dominated for over 10 years by interferon betas and Copaxone (glatiramer acetate, Teva).

Datamonitor analyst Trung Huynh said that its approval would likely spur a rush of similar therapies to market over the next few years.

“Approval of Movectro in Russia is an important milestone for the MS market and will open the floodgates for other oral therapies,” he said, adding that despite lingering safety concerns, oral treatments would be the key drivers for what is expected to be a $US9.5 billion MS market by 2014.

Novartis had been hoping that its oral drug Gilenia (fingolimod) would be the first in the world to gain approval. Datamonitor predicts however that Gilenia will be first to be approved in the all-important U.S market, where the FDA recently gave it unanimous approval, just days after Merck announced the resubmission of its application for oral cladribine.

Nevertheless, the fact that Movectro is the first new MS therapy to enter Russia’s $200 million MS market in over 10 years augurs well for its approval in Europe, expected by the third quarter of this year.

At the time of publication the TGA (Therapeutic Goods Administration) had not responded to requests from Australian Life Scientist for more information on the liklihood of Merck gaining approval to market Movectro in Australia.

Meanwhile, Merck announced recently that it had extended by a year its partnership with Adelaide biotech Bionomics aimed at developing treatments for MS and other autoimmune diseases based on compounds derivd from the latter’s Kv1.3 program.