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Development of an Orphan Drug by a Start-Up Company: MetroGel® for Rosacea

Published online by Cambridge University Press:  10 March 2009

Robert J. Borgman
Robert J. Borgman
Affiliation:
Curatek Pharmaceuticals
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Abstract

The Orphan Drug Act of 1983, along with the discovery of a new use for a known drug and an investor willing to assume the necessary risk, brought about the formation of a start-up pharmaceutical company. The primary incentive of the Orphan Drug Act of seven years of marketing exclusivity provided the protection from competition necessary for recovery of the significant research and development and marketing costs. The orphan product, MetroGel®, for the treatment of rosacea, required approximately five years of development before it was approved for marketing by the Food and Drug Administration. MetroGel® has become the number one drug in the United States for the treatment of rosacea. It currently is marketed in other countries through a licensing agreement with a major pharmaceutical company.

Type
Special Section: Orphan Technologies
Information
International Journal of Technology Assessment in Health Care , Volume 8 , Issue 4 , Fall 1992 , pp. 566 - 572
Copyright
Copyright © Cambridge University Press 1992

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References

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