Amira Drug Gets Orphan Status
Bruce V. Bigelow4/20/11
The U.S. Food and Drug Administration has granted orphan drug designation to AM152, the lead drug candidate under development at San Diego’s Amira Pharmaceuticals for treating idiopathic pulmonary fibrosis, a lung disease that makes it difficult to breathe. In a statement yesterday, the company says the designation provides a seven-year period of market exclusivity and potential tax credits and regulatory advantages to the developer of a new drug therapy for diseases that affect fewer than 200,000 people in the United States. Amira says it is completing early stage tests of a compound that seems to help block the activation of a cellular receptor implicated in tissue fibrosis and related disease processes.
