Biopharma company Chiasma Inc. has been granted orphan drug status by the US Food and Drug Administration (FDA) for its investigational drug, Octreolin, an oral form of octreotide acetate for the oral treatment of acromegaly. Acromegaly is a hormonal disorder that results from an excess of growth hormone.
If a New Drug Application (NDA) is approved, Octreolin should qualify for seven years of market exclusivity, potential tax credits, and a waiver of the prescription drug user fee for the marketing application.
Chiasma has successfully completed a Phase I clinical study and plans initiating a Phase III trial by the end of the year.
Chiasma will submit an application for Orphan Medicinal Product Designation to the European Medicines Agency (EMA) shortly.
The pool of patients eligible for Octreolin treatment for acromegaly is estimated to be between 10,000 and 15,000 in the US and a similar number in Europe.
The company is also developing a drug for treating chronically high blood pressure via the liver.
The company is funded by ARCH Venture Partners, MPM Capital, F2 Ventures, 7 Health Ventures and the MPM Novartis Strategic Fund.
Published by Globes [online], Israel business news - www.globes-online.com - on June 28, 2010
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