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Chiasma Receives Orphan Drug Designation From the FDA for Octreolin™ for the Oral Treatment of Acromegaly
Date:6/27/2010

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In addition, the Company is developing Octreolin as a potential treatment for patients with portal hypertension (PHT); a clinical trial to evaluate this new indication is expected to start in December of 2010. Chiasma will evaluate whether Octreolin may improve quality of life, prevent or reduce bleeding events, and lower mortality rates for the estimated 80,000 PHT patients in the U.S. and an equal number in Europe. There are currently no drugs approved for PHT in the U.S.

The Company plans to request orphan drug designations for Octreolin for PHT in the U.S. and in Europe.  The Company also intends to proceed with the aforementioned 505(b)(2) NDA regulatory pathway in the U.S. and its equivalent, the Hybrid Application, in Europe.

How Octreolin Works

Octreolin is a product in capsule form that contains octreotide acetate, a 1.0 kDa peptide, and the Company's unique TPE technology. The TPE system allows its drug cargo to cross mucosal epithelia in the small intestine by inducing a temporary opening of the Tight Junctions that seal and regulate passage between cells (the paracellular route). This effect on the epithelia is rapid and fully reversible. The drug reaches the bloodstream effectively in its native active form.

About Chiasma

Chiasma is evaluating its proprietary technology with approved drugs, which may enable their being switched from injectable to oral, and potentially may also result in new indications or otherwise improved labels.  The Company's TPE technology promotes the delivery of drugs to the GI wall and from there to the liver.  It is applicable t
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SOURCE Chiasma, Inc.
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