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Halo Therapeutics' HT-100 Receives FDA's Orphan Designation for Duchenne Muscular Dystrophy
Date:1/4/2012

NEWTON, Mass., Jan. 4, 2012 /PRNewswire/ -- Halo Therapeutics, LLC, a clinical-stage biopharmaceutical company developing novel therapeutics for rare fibrotic diseases, today announced that the United States Food and Drug Administration (FDA) granted orphan drug designation for HT-100 for treatment of Duchenne muscular dystrophy (DMD). DMD is a progressive and fatal neuromuscular disorder, which afflicts approximately 1 in 3,500 boys worldwide. HT-100, also known as halofuginone, is an orally available small molecule drug candidate that is being developed to reduce fibrosis and promote healthy muscle fiber regeneration.

The FDA grants orphan designation to promote development of therapies to treat rare diseases. Once this designation is granted, the sponsor may be eligible for a range of incentives including FDA grant funding for clinical trial costs, tax credits related to development expenses, waiver of FDA user fees, and a seven-year period of marketing exclusivity in the U.S. following FDA approval.

Halo Therapeutics has an innovative business model. The company was founded and funded to date by two DMD patient foundations, Charley's Fund (www.charleysfund.org) and the Nash Avery Foundation (www.nashaveryfoundation.org), and executive management. The company is led by biopharma veterans Marc Blaustein as CEO and Gene Williams as Executive Chairman, and has assembled a team of experienced drug developers and DMD experts to rapidly evaluate HT-100 for DMD. Mr. Blaustein brings to Halo 15 years of experience in the biopharmaceutical industry, most recently at Dyax Corp. and Alkermes. He has directed manufacturing, commercial operations, and business development functions and led development efforts for two products that subsequently received FDA approval. Mr. Williams brings decades of industry experience, including directing the fibrotic disease portf
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