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Novartis' MS drug shows further promise

Published on 02/10/06 at 12:35pm

A new treatment for multiple sclerosis currently being developed by Novartis has shown further promise in slowing the progress of the debilitating disease.

FTY720 (fingolimod) is a new first-in-class treatment which entered phase III trials earlier this year, but further phase II trials have produced potentially exciting results.

The data show that up to 77% of patients taking once-daily oral FTY720 remained free of relapses over two years. They also maintained a low rate of inflammatory disease as measured by magnetic resonance imaging (MRI).

New pre-clinical data has also been presented suggesting the drug may work through multiple modes of action. The study suggests that in addition to its anti-inflammatory effects, the treatment may also reduce neuro-degeneration and enhance repair of the central nervous system (CNS) affected by MS.

"The results are very promising, and if confirmed by phase III data, FTY720 could contribute significantly to improving the quality of life of patients with relapsing MS," said Professor Ludwig Kappos, chief trial investigator and head of the Outpatient Clinic Neurology-Neurosurgery at the University Hospital in Basel, Switzerland.

"The data show that FTY720 may offer important clinical benefits. In addition, it is given conveniently in the form of a once-daily pill."

Last year, key phase II data suggested the drug to be more effective than existing treatments in delaying the progress of the disease. This efficacy, coupled with its convenient pill form (contrasting with injections needed with existing drugs) means FTY720 could make a major impact on the treatment of the condition.

But development of MS drugs is notoriously risky, and phase III trials will take several years to prove the drug's promise.

Analysts forecast a launch by 2009, with peak sales expected to reach approximately $600 million.

Serono and Teva, two companies with established presence in the MS market are collaborating on a rival oral treatment.

Mylinax (cladribine) entered phase III trials in early 2005, and like the Novartis drug, targets certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis.

One drug already on the market which uses a similar mechanism is Roche/Genentech's MabThera. The drug is already in phase II trials for MS and could build on its already considerable profile in non-Hodgkins Lymphoma and rheumatoid arthritis. 

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