Obecure's hypothesis is that Histalean(R)'s "prohistamine" activity counters SGA's side effects by offsetting their antihistamine action. Indeed, the current clinical trial results suggest that the dose required to effect mitigation of SGA-associated side effects (at least 144 mg/day) may exceed that which is approved for Menieur's disease (48 mg/day). As such high doses have been shown safe, alone and in conjunction with olanzapine, the company has an interest in pursuing the clinical evaluation of innovative high dose and extended release formulations, as developed by the Grunenthal Italian subsidiary. "This agreement is a major step forward in our effort to develop Histalean(R) and ensure its benefit to psychiatric patients treated with antipsychotic drugs" said Dr. Yaffa Beck, Chief Executive Officer of Obecure, adding that "It not only assures us a high quality drug manufacturer and supplier of extended release betahistine formulations for our clinical studies, it also enhances the probability of our clinical success, as well as our intellectual property portfolio."

Fulfilling a great and previously untapped market need, the improved tolerability and efficacy of the second generation antipsychotic drugs (SGA), was translated to annual sales growth from <$1 billion in 1994 to >$15 billion in 2009. However, in recent years there has been growing concern of regulators and practitioners about these drugs' induction of weight gain, reducing patients' compliance and exposing them to metabolic syndrome, diabetes and cardiovascular disorders; a concern which has resulted in FDA's issuance of black box warnings, and which has greatly affected prescription decisions. Moreover, daytime sleepiness (somnolence) induced by these drugs is seriously impacting patients quality of life - prohibiting driving, hampering their ability to hold jobs and/or continue with their education.

According to the terms of the agreement, Grunenthal will supply Obecure with the XR betahistine and matching placebo tablets for use in its upcoming clinical studies and pending successful clinical outcomes will exclusively manufacture XR-Histalean(R) and be entitled to license it for distribution and sale in Italy.

SOURCE Obecure Ltd