Top 10 for '09: No. 8

No. 8: The Approval Race for an MS Pill

In 2009, Novartis and Merck Serono became the main contenders to market the first-ever pill for relapsing-remitting multiple sclerosis (RRMS).

Aaaaand they're off. Quickly way out, in the middle of the track, Merck Serono takes the early lead.

In January, Merck Serono described favorable 2-year data from an extension phase of its placebo-controlled phase 3 study (CLARITY) of an oral form of cladribine.*

He's challenged on the outside by Novartis, as they race into the turn.

Several months later, Novartis announced positive data from its phase 3 study, in which the novel oral agent, fingolimod, outperformed the standard treatment (not placebo) of IM interferon beta (Avonex; Biogen Idec).

Novartis moving up on Merck Serono as they round the turn.

In August, the FDA announced the approval of Novartis's copycat version of Betaseron (interferon beta-1b; Bayer Schering) for RRMS. Approval came by way of an intricate manufacturing deal with Bayer Schering that began 2 years ago and was apparently intended to prime Novartis's sales team in the MS market.

In the stretch. It's Merck Serono still in front. Merck Serono by a length and a half.

In October, Merck Serono announced its NDA submission for the fast-track approval of oral cladribine for RRMS.

But here comes Novartis on the outside. Novartis comin' after him.

The same day, Novartis announced positive data from its 2-year placebo-controlled phase 3 study of fingolimod in more than 4000 individuals with RRMS (FREEDOMS).

Also getting involved is Teva and Biogen Idec, and looking for a hole on the inside is sanofi-aventis. 

Other novel oral compounds in late-stage development for MS include Teva's laquinimod, Biogen Idec's dimethyl fumarate, and teriflunomide from sanofi-aventis.

Oh, going down now, going down, Merck Serono. Merck Serono takes a spill.

In December, the FDA announced that it refused to file Merck Serono's NDA for oral cladribine, probably on the basis of an incomplete application. The company said that it would request a meeting with the FDA to understand any deficiencies in its application.

Novartis had previously announced that it would file its NDA for fingolimod by the end of the year, but it doesn't look like that's going to happen.

The race isn't over.

CLARITY = Cladribine Tablets Treatment MS Orally; FREEDOMS = FTY740 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis; NDA = new drug application.

* Cladribine, a purine analog, has been marketed as the injectable Leustatin [Ortho-Biotech] since 1993 for hairy cell leukemia.