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Rilutek Will Gain Competition

February 24, 2006

The findings represent good news for pharmaceutical firms developing drugs to treat ALS, a progressive neurodegenerative disease that attacks and destroys motor neurons.

At present, ALS is difficult to diagnose in the early stages as it mimics other diseases such as multiple sclerosis, and symptoms like fatigue and general muscle weakness are often mistaken for merely signs of aging. Worryingly, often up to 80% of motor neurons have been destroyed before the disease becomes apparent and up to 45% of ALS patients are given at least one misdiagnosis before a definitive diagnosis is made.

The Mount Sinai researchers compared cerebral spinal fluid from ALS patients, patients with other neurological disorders, and healthy individuals. They found that fluid from ALS patients had significantly lower concentrations of three proteins than either of the other groups. Evaluating the levels of these three proteins proved 95% accurate for diagnosing ALS.

The researchers discovered that the changes in concentration of these proteins were evident within 1.5 years of onset of symptoms. With current methods the average time from onset of symptoms to diagnosis is two years. Testing for these protein concentrations may provide a means of early diagnosis, allowing patients to receive treatment earlier. The discovery raises the possibility that a test to accurately diagnose ALS could be successfully developed.

Furthermore, the findings could aid the development of new ALS drugs. For example, a test could prove invaluable to pharmaceutical companies recruiting patients for ALS drug trials, as it would help select patients at earlier stage of disease. At present, Sanofi-Aventis' Rilutek (riluzole) is the only FDA-approved ALS treatment but several companies are working on their own offerings, including Avicena, ExonHit Therapeutics and CytRx.

It is not only the prospect of easier trial recruitment and the likelihood of the market expanding thanks to earlier prescriptions that could prove enticing to drug developers. Another opportunity lies in store if companies can initially gain an ALS indication with a view to approval in more lucrative indications, like Alzheimer's disease. The presence of such a market opportunity should ensure that Rilutek is forced to face increased competition in the future.

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