First oral multiple sclerosis pill cladribine may hit markets by 2010: Merck KGaA

Cladribine, a drug to treat multiple sclerosis in pill form from Merck KGaA has been submitted for review with US FDA.

Cladribine is a proprietary investigational oral formulation of Merck KGaA to reduce relapses in people with relapsing forms of multiple sclerosis (MS).

Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.

Cladribine pills has the potential to be the first orally administered therapy available for people living with relapsing multiple sclerosis.

Currently, all the medicines approved for the treatment of multiple sclerosis are parenteral therapies.

“If approved, short-course therapy with cladribine tablets could transform the way people approach their treatment options, and meet an unmet need as an oral, disease modifying drug available for MS,” said Fereydoun Firouz, President and CEO of EMD Serono, Inc., a US subsidiary of Merck.

Merck KGaA’s New Drug Application (NDA) to the US Food and Drug Administration is supported by results from the CLARITYa study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of cladribine Tablets in people with relapsing-remitting MS.

Study participants were randomized to one of three different treatment groups consisting of two different dose regimens of Cladribine tablets or matching placebo tablets (1:1:1 ratio). Cladribine tablets were given in two or four treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days, which means study patients took Cladribine Tablets for 8 to 20 days during the year.

In the second year, two treatment courses were administered to all patient groups. The primary endpoint of the CLARITY study was the relapse rate at 96 weeks. Secondary endpoints included MRI endpoints, proportion of subjects relapse-free and disability progression at 96 weeks.

cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.

Out of the 1,326 randomized patients, 90% of patients treated with cladribine tablets completed the study (92% in the lower total dose group and 89% in the higher total dose group) compared to 87% in the placebo group.

The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at other recent international scientific meetings.

Merck Serono submitted a marketing authorization application to the European Medicines Agency (EMEA) for Cladribine Tablets in July 2009.

Merck KGaA expects cladribinethe pill to reach the U.S. market in the second quarter of 2010, and European market in the last quarter of 2010.

US market for multiple sclerosis treatment is about $8.6 billion. MS drug market is currently dominated by injectables from Teva, Biogen Idec, Bayer and Merck KGaA itself.

Apart from Merck KGaA, Novartis and Biogen Idec are aslo developing oral therapies for multiple sclerosis.

Novartis is planning to seek U.S. and European approval for its MS pill known as FTY720 at the end of this year.Biogen Idec’s oral MS drug, known as BG-12 is still in clinical studies.

What is multiple sclerosis?

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that more than two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.