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Histalean

OBEcure Ltd.

Drug Names(s): Betahistine; OBE101

Description: Histalean is comprised of betahistine, a histamine H1 receptor agonist and partial H3 receptor antagonist, that is available worldwide except in the US, as a generic prescription drug for Ménière's disease (vertigo). In the brain, histamine may play a role in eating as a neurotransmitter. Histamine activation of the post-synaptic H1 receptor decreases food consumption. The pre-synaptic H3 receptor has an auto-regulatory role on histamine production. Thus, inhibition of the H3 receptor may also decrease food intake.

Deal Structure: In May 2008, Obecure announced the execution of a strategic manufacturing and supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group (Grunenthal). 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 Histalean for co-marketing in Italy.

In February 2010, Obecure announced the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA. The agreement extends the 2008 strategic supply agreement between the parties to know-how and patents covering extended release formulations of betahistine dihydrochloride.

According to the terms of the agreement,...See full deal structure in Biomedtracker


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