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CepTor Receives Dual Orphan Drug Designation for Myodur (C101) for Duchenne and Becker Muscular Dystrophies
Author:佚名    InfoSource:pharmalive.com    Hits:    Update Time:2006-2-3 Recommend

HUNT VALLEY, Md.--(BUSINESS WIRE)--Jan. 25, 2006 - CepTor Corporation (OTCBB:CEPO), a development-stage biopharmaceutical company focusing on cell-targeted therapeutic products for neuromuscular and neurodegenerative diseases, announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) granted orphan drug designation for Myodur for both Duchenne and Becker muscular dystrophies. The Orphan Drug Act (ODA) of 1983 provides for the granting of orphan designation for products that address serious or life threatening disease that affect less than 200,000 people in the U.S. and where no other definitive therapy is currently available. The spirit of the ODA legislation is to provide incentives to promote research on orphan diseases. As such, compounds, like Myodur, that are granted orphan designation, provide their manufacturers tax breaks, potential regulatory expediency including accelerated reviews and seven years of market exclusivity after commercial approval. CepTor recently announced the submission of its Investigational New Drug application (IND) to initiate phase I/II clinical trials with Myodur in Duchenne boys.

Duchenne is an X-linked defect of the dystrophin gene that affects about 25,000 boys in the U.S and EU. This devastating disease normally results in the need for walking braces by about ages 6-8, wheelchair dependence by ages 10-13 and death in late adolescence. Becker is a less aggressive form of the disease that affects adults and is believed to be about 10-15% as large as the Duchenne population. Earlier published work suggests a cause and effect relationship between abnormally high up regulation of calpain and these muscle wasting diseases. Calpain is a protease which causes the accelerated destruction of muscle tissue. CepTor's Myodur is a muscle cell targeted product that inhibits calpain in an effort to preserve muscle tissue.

William Pursley, CepTor's Chairman and CEO, said, "The orphan drug office reviewed our application quickly and did the right thing by granting dual orphan designation since Duchenne and Becker are caused by defects in the same gene. We believe this is an important milestone for several reasons. Indirectly, it provides a strong extension of the intellectual property around our technology. The competition free environment that the market exclusivity portends is an obvious advantage. Most importantly, it creates a significant opportunity to work in partnership with the FDA in an expedited manner to address this devastating disease."

About CepTor

CepTor Corporation is a development-stage biopharmaceutical company engaged in the discovery, development, and commercialization of proprietary, cell-targeted therapeutic products for the treatment of neuromuscular and neurodegenerative diseases with a focus on orphan diseases. The Company's mission is to increase the quality and quantity of life of people suffering with these diseases. An orphan disease is defined in the United States as a serious or life-threatening disease that affects less than 200,000 people and for which no definitive therapy currently exists. CepTor Corporation seeks to create an efficient orphan drug platform by taking advantage of the legislative, regulatory and commercial opportunities common to these rare diseases. CepTor's primary efforts are currently being focused on moving its lead product, Myodur, into phase I/II clinical trials for Duchenne muscular dystrophy. The Company's broad platform technology also includes the development of products for multiple sclerosis, retinal degeneration and epilepsy.

This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborator's ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement.

Contact CepTor Corporation Donald W. Fallon, 410-527-9998 Fax: 410-527-9867 dfallon@ceptorcorp.com or Wolfe Axelrod Weinberger Assoc. LLC Donald C. Weinberger, 212-370-4500 Fax: 212-370-4505 don@wolfeaxelrod.com or Media: Alisa D. Steinberg, 212-370-4500 Fax: 212-370-4505 alisa@wolfeaxlrod.com


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