DUSA signs $3 million deal with Stiefel to market Levulan Kerastick

By E. Janene Geiss

Philadelphia, Jan. 18 - DUSA Pharmaceuticals, Inc. said Wednesday that it has entered into an exclusive marketing, distribution and supply agreement for Latin America with Stiefel Laboratories, Inc. for current and future uses of DUSA's proprietary Levulan Kerastick for Photodynamic Therapy in dermatology.

The agreement, which has an initial term of 10 years, will expand the distribution of Levulan beyond the North American market for the first time, taking it into Mexico, Central America and South America, according to a company news release.

Stiefel will make up to $3 million in milestone payments based upon receipt of final pricing approval of the product from Brazilian regulatory authorities and achievement of predetermined minimum purchase levels in the territory, subject to certain terms and conditions, officials said.

DUSA said it will manufacture the Kerastick for Stiefel at its manufacturing facility in Wilmington, Mass.

The parties have certain rights to terminate the agreement prior to the end of the initial term, officials said, and Stiefel has an option to extend the term for an additional 10 years on mutually agreeable terms and conditions.

DUSA said it has completed its portion of the Brazilian regulatory submission for the use of Levulan Photodynamic Therapy for actinic keratoses.

As part of the agreement, Stiefel will complete final integration and submission of the data to the Brazilian regulatory agency with a market launch expected in late 2006 or early 2007, officials said.

Stiefel will prepare and file the regulatory applications in other countries in the territory subject to the terms of the agreement, officials said.

"Stiefel's significant presence in the Latin American dermatology market puts them in an ideal position to maximize the opportunity for Levulan Photodynamic Therapy. Our agreement with Stiefel is the next step in our business strategy to gain worldwide distribution of Levulan Photodynamic Therapy by partnering with leading companies around the globe," Robert Doman, DUSA's president and chief operating officer, said in the release.

Stiefel is a Coral Gables, Fla., independent pharmaceutical company specializing in dermatology.

DUSA, based in Wilmington, Mass., is a biopharmaceutical company engaged in the development of Levulan Photodynamic Therapy and Photodetection for multiple medical indications, with its primary focus in dermatology.

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