Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Published on February 17, 2010 at 4:51 AM · 1 Comment

Obecure Ltd (http://www.obecure.com)., a subsidiary of Bio-Light Israeli Life Science Investments Ltd. (TASE: BOLT), announced today the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group (Grunenthal). The agreement extends the 2008 strategic supply agreement between the parties to know-how and patents covering innovative extended release formulations of betahistine dihydrochloride, the active pharmaceutical ingredient of the company's proprietary drug Histalean(R). The extended release formulation (XR) allows the drug to achieve greater plasma concentrations for a longer duration and is thus likely to improve its beneficial actions.

Histalean(R) is comprised of betahistine dihydrochloride, a dual action histamine type H1 receptor agonist and a histamine type H3 negative autoreceptor inhibitor. It is a highly safe generic drug, approved since the 1960s for treatment of Meniere's disease (vertigo) in most countries. In the US, although its safety was not in doubt, the drug was withdrawn in 1972 for insufficient efficacy in this disease.

Obecure is focused on development of Histalean(R) as adjunctive to antipsychotic drug therapy for improved treatment of schizophrenia, bipolar disorder and major depression. Obecure has recently announced the outcomes of randomized, placebo controlled Phase 1b and pilot Phase 2 trials, showing that co-administration of Histalean(R) with olanzapine (Zyprexa(R)), safely and significantly reduced weight gain and somnolence, two of the most serious side effects associated with this drug, as with most of the second generation antipsychotics as a drug class, also including risperidone (Risperdal(R)), quetiapine (Seroquel(R)) and aripiprazole (Abilify(R)). Interestingly, both side effects are mainly caused by the affinity of these drugs to histaminic H1 receptor and their inhibition of histaminergic neurotransmission.

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  1. Daniel Haszard Daniel Haszard United States says:

    Prescribed off label for PTSD was ineffective
    Gave me diabetes cost thousands in co-pays made me sleepy

    *FIVE at FIVE*

    The Zyprexa antipsychotic drug,whose side effects can include weight gain and diabetes, was sold for "children in foster care, people who have trouble sleeping, elderly in nursing homes."

    *Five at Five* was the Zyprexa sales rep slogan, meaning 5mg dispensed at 5pm would keep patients quiet. Google * Eli Lilly Zyprexa * and read the links.This is for a product that we put in our children's bodies.

    I took Zyprexa it gave me diabetes and was as addictive as tobacco.How so? Because withdrawal is accompanied by severe insomnia for 6 weeks.

    Daniel Haszard Zyprexa Whistle-blower

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