The anti-obesity drug being developed by Bio-Light Israel Life Sciences Investments Ltd. subsidiary ObCure Ltd. is scheduled to reach the market in 2007, according to Bio-Light’s prospectus, part of which "Globes" has obtained. The marketing timetable for the drug depends, among other things, on the trial program that the US Food and Drug Administration (FDA) will require from ObCure. The FDA is due to rule shortly whether ObCure can skip directly to Phase II (safety and effectiveness) trials, or even to Phase III (expanded controlled and uncontrolled effectiveness).
ObCure’s use of the drug is based on research by Dr. Nir Barak at Beilinson Medical Center. Barak found that Betahistine, originally developed for treatment of Meniere's Disease, was also effective against obesity.
The drug was removed from shelves and banned for use in the US, after the FDA decided that it was ineffective for its original purpose. The drug is still sold in Europe for treating Meniere's Disease.
ObCure registered a patent in the US for treatment of obesity using the drug. Considering the fact that the drug was previously prescribed for 60 million patients without any significant side effects coming to light, the company hopes that the FDA will not require proof of effectiveness, and that it will be able to greatly shorten its time to market.
The drug activates a receptor named H1, which constitutes part of the appetite system. ObCure hopes that the drug can be used to treat severely obese patients (one third of the adult population in the US) and patients who have begun taking anti-psychotic drugs, which are known to cause obesity. Barak explains that obesity is one of the severe side effects of anti-psychotic drugs, which significantly reduces the willingness of patients to take them. His research shows that anti-psychotic drugs cause obesity by blocking the H1 receptor.
There are two other ethical drugs, Sibutramine and Orlistat, for treatment of obesity, and amphetamine-based generic drugs. The market for these drugs in the US totals $1 billion, but they have severe side effects. Sibutramine can cause hypertension, epileptic-type seizures, fatigue, and dizziness, Orlistat can cause abdominal pain and irregular urination and defecation, and the amphetamines can cause addiction and physical nervousness.
Mor Research Applications Ltd., Clalit Health Services’ technology transfer company, owns a patent for ObCure’s the drug. Bio-Light Israel bought the rights to use the patent from Mor for an initial $75,000 payment, plus special payments later when milestones are reached and royalties on sales.
Published by Globes [online] - www.globes.co.il - on December 1, 2005