DUSA Pharmaceuticals, Inc. (DUSA) Friday said it would no longer manufacture and market vitamin-mineral supplement Nicomide as a prescription product for treating skin diseases. The decision comes as a proactive action in response to discussions with the Food and Drug Administration - FDA.
Nicomide was previously marketed without FDA pre-market application as acne medication, available in topical cream, topical gel and vitamin supplement form. Nicomide is indicated to reduce inflammation of the skin, thereby reducing acne. Acne is an inflammatory disease of the sebaceous glands and hair follicles of the skin with indications of eruption of pimples or pustules, especially on the face.
The drug was acquired by DUSA through its merger with Sirius Laboratories, Inc., however, shortly after the acquisition, FDA required DUSA to comply the product in a timely manner with current regulations. As a result, a voluntary hold has been placed by DUSA on existing inventory of Nicomide under its control, pending an upcoming meeting with the FDA.
Bob Doman, President and Chief Executive Officer, DUSA said, "Current regulatory environment, will allow DUSA to explore new marketing channels, product categories (DSHEA) and the possible sale or licensing of the product in order to meet strong product demand while DUSA complies with FDA policy guidelines."
The company also said efforts were underway to re-label additional inventory with Dietary Supplement Health and Education Act compliant labeling. Nicomide represented the substantial majority of DUSA's non-Photodynamic Therapy revenues which contributed $9.4 million to full year 2007 revenues.
The company expects both the price and volumes of the Nicomide DSHEA labeled product to be considerably less than historical Nicomide levels.
DUSA is currently trading at $1.80, down $0.17 or 8.63%, on a volume of 49,158.
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