serono to start late-stage trials of ms pill UPDATE 2-Serono to...

serono to start late-stage trials of ms pill UPDATE 2-Serono to start late-stage trials of MS pill
January 11, 2005 4:12am ET (Reuters)

(Adds analyst comment, shares)

ZURICH, Jan 11 (Reuters) - Serono SA will start late-stage trials of its multiple sclerosis pill Mylinax this quarter, giving Europe's biggest biotechnology firm a headstart in the race to be first to the market with an anti-MS pill.

A two-year, Phase III trial of Mylinax, known generically as cladribine, will start slightly earlier than expected in the first quarter, Serono and co-developers IVAX Corp. said in a statement on Tuesday.

Analysts noted that the pill could generate peak sales of more than $1 billion and was set to be the first oral MS treatment to reach the market, beating a similar product by GlaxoSmithKline Plc .

"This is very positive news for Serono," Vontobel analysts wrote in a note to clients. "With a direct start in Phase III trials, Serono could be the first firm which leads an oral MS medicine with potential blockbuster status to market."

Phase III trials are a precursor to regulatory filing and involve giving the drug in question to large groups of people to confirm that it works and what side effects it has.

Shares in Serono rose over 1 percent to 759 Swiss francs, helping recoup some of the ground lost last year on fears the firm's most important product, its injectable MS drug Rebif, would face increasing competition.

Serono has said it could have its product on the market in 2008, ahead of GlaxoSmithKline which plans to file its drug for approval in 2008, implying a launch in 2009.

Analysts at ABN AMRO said Serono's trial start date was slightly earlier than expected, adding that the drug would broaden Serono's current palette of MS drugs and help shield the firm from competition to its flagship Rebif treatment.

Mylinax is an oral form of cladribine, which interferes with the way certain white blood cells linked to multiple sclerosis spread, Serono said. Clinical trials of cladribine in injection form have already proved positive.

Mylinax is being developed by Serono and IVAX under a worldwide agreement signed in 2002.

Patients with MS, a notoriously difficult disease to treat, currently have no choice but to inject their medicine. MS affects about 2 million people worldwide, with symptoms such as blurred vision and problems with strength and coordination. End of Story