Novum Pharmaceutical Research Services Leads the Way in Generic Topical Corticosteroid Approvals

Pittsburgh, PA June 24, 1999: Novum Pharmaceutical Research Services, a leading provider of Phase I clinical research services to the generic, pharmaceutical, and biotechnology industries, is pleased to announce that in May of this year the Food and Drug Administration (FDA) approved the eighth Abbreviated New Drug Application (ANDA) for a generic topical corticosteroid where the clinical conduct and analysis was conducted by Novum.

Chris Hendy, Ph.D., President and CEO said, "We are delighted with the continued success of our unique development service for generic topical corticosteroid products. Our clients have clearly benefited from our experience as evidenced by the number of product approvals by the FDA. Since the issuance in 1995 of the FDA Guidance on bioequivalence studies for the generic topical corticosteroids, twelve such products have received marketing approval. Eight of these approvals have resulted from data and analysis from Novum. The FDA has conducted numerous pre-approval inspections of these studies at Novum and accepted the methodology. Data generated from studies conducted at Novum has also been used to support marketing applications in Canada, Europe, and Israel."

Since 1995, Novum has conducted sixty-eight vasoconstrictor studies with topical corticosteroids, covering twenty-four different products and formulations and involving the participation of over two thousand study participants. Novum has also conducted potency classification studies for several investigational corticosteroid products and formulations currently under evaluation by the FDA.

Dr. Hendy added, "The experience of the scientists and the operational staff involved in the performance of these extremely specialized studies, supported by our automated data capture system and excellent quality control procedures, allows us to provide sponsors with study results, often within hours of completion of the clinical conduct. Our unique formulation screening protocols, our unmatched experience with a wide range of products, and our rapid data analysis procedures significantly shorten the time needed for our sponsors to make informed decisions on the quality of their formulations and accelerate getting their products to the market place.

For more information on Novum's Phase I research capabilities, including topical corticosteroid development, contact Michelle Strausbaugh, Manager, Client Services, Novum Pharmaceutical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206. Tel: (412) 363-3300 ext. 541, Fax: (412) 362-5783, E-mail: mstrausb@nprsinc.com.