Obecure Signs Strategic Agreement with Farmaceutici-Formenti of the Grunenthal Group for Manufacturi
RAMAT GAN, Israel--(BUSINESS WIRE)--Obecure Ltd., a clinical stage company focused on development of novel therapeutics for weight management, announced today the execution of a strategic manufacturing and supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group (Grunenthal).
Obecure is currently investigating the use of HistaleanTM in Obesity and prevention of drug-associated weight. Histalean™ is comprised of betahistine, an established drug, approved in Europe for treatment of Ménière’s disease (vertigo). The Grünenthal Group, founded 1946 in Germany, is a privately owned pharmaceutical company with annual drug sales greater than 800 million Euros (2006), mainly in Europe and Latin America. Grunenthal, via its Italian subsidiary, is a leading manufacturer of generic betahistine, approved and marketed in Europe under the trademark MicroserTM. MicroserTM has a leadership position in Italy, holding > 60% of the total 16 million Euros Italian betahistine market.
According to the terms of the agreement, Grunenthal will supply Obecure with betahistine and matching placebo tablets for use in its upcoming clinical studies. Pending successful development and receipt of a marketing authorization of Histalean™ in Europe, Grunenthal will exclusively supply the betahistine tablets for packaging as Histalean™ for all countries in European Community. Grunenthal will also be entitled to license HistaleanTM for co-marketing in Italy.
"This agreement is a major step forward in the development of HistaleanTM for Obesity and weight management and to ensure its availability to patients upon approval," said Dr. Yaffa Beck, Chief Executive Officer of Obecure. "The Grunenthal Group is a leader in the European pharmaceutical industry and provides Obecure access to large scale production and marketing organization and the capacity to meet production and quality goals."
On August 29th of 2007 Obecure announced post-hoc findings of its FDA-approved Phase II trial, suggesting that a 12 week treatment with Histalean™ may effect substantial weight reduction in obese women, younger than 50, with body mass index (BMI) ranging from 30 to 40. These findings replicated a prior clinical study evaluating the drug in obese women for 4 weeks.
The company is also pursuing clinical investigation of Histalean™ for prevention of drug-associated weight gain and, with the partial support of Eli Lilly, is currently conducting a double-blind, placebo-controlled trial evaluating the drug for prevention of the weight gain associated with the anti-psychotic drug ZyprexaTM (Olanzapine) in Canada and in Israel. In addition, Obecure is supported by the National Institute of Health (NIH) which is conducting a double blind, dose ranging trial to evaluate the mechanism of action of Histalean™ and its effect on food consumption and energy expenditure.
The company is currently preparing to conduct additional dose ranging clinical studies for both indications (Obesity and Olanzapine-associated weight gain) using Histalean™, with a particular focus on pre-menopausal women.
About Histalean™
Histalean™ is comprised of betahistine, a generic drug currently approved and marketed worldwide, except in the United States, for the treatment of Meniere\'s disease (vertigo). Obecure is investigating the drug, an H1 receptor agonist and partial H3 receptor antagonist, for the treatment of obese individuals and for other weight management indications. Betahistine has an excellent safety profile and has been used for treatment by more than 100 million patients suffering from vertigo and dizziness.
About Obecure
Founded in 2005, Obecure Ltd. is a biopharmaceutical company dedicated to the development of weight management drug therapies. The Company is currently pursuing the clinical development of its lead compound Histalean™ for general obesity and for weight gain associated with anti-psychotic drug therapy. Obecure has a worldwide exclusive license from Mor Research Applications Ltd., the Technology Transfer Office of Clalit HMO to clinically develop and commercially exploit the technology, as developed by Dr. Nir Barak, a specialist in nutrition and internal medicine at the Rabin Medical Center in Tel Aviv. More information: www.obecure.com
Obecure is a subsidiary of Bio-Light Life Science Investments Ltd., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT)
About Grünenthal
Grünenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. The company discovers, develops, produces and markets high therapeutic value pharmaceuticals that contribute to patients’ ability to control their own lives. Grünenthal is an independent, family-owned German company with companies in 29 countries all over the world. Founded in 1946, the company employs 1,900 people in Germany and 4,800 worldwide. In 2006, Grünenthal achieved revenues of 813 million Euros. More information: www.grunenthal.com
