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Published on 11/10/2005 in the Prospect News Biotech Daily.

Cellegy, ProStrakan renegotiate deal for Rectogesic distribution in European Union

By E. Janene Geiss

Philadelphia, Nov. 10 - Cellegy Pharmaceuticals, Inc. said Thursday that is has renegotiated the European Union License and Distribution Agreement for its product Rectogesic with licensee ProStrakan Group plc.

Under the terms of the amended agreement, ProStrakan will assume responsibility for all manufacturing and other product support functions and will purchase the product directly from the manufacturer rather than purchasing from Cellegy under the terms of the original agreement, according to a company news release.

In return, Cellegy will receive a payment of $2 million and may receive future milestone payments of up to $750,000 upon approval of the product in certain major European countries. Cellegy will benefit from reduced infrastructure costs by having its partner take over manufacturing responsibilities.

Rectogesic is a 0.4% topical nitroglycerin ointment indicated for the relief of pain associated with chronic anal fissures. In September 2004, the product was approved by the U.K. Medicines and Healthcare Products Regulatory Agency for sale in the U.K. It was launched by ProStrakan in the U.K. in May 2005, officials said.

In December 2004, Cellegy and ProStrakan entered into an exclusive license agreement for the commercialization of the ointment, which is known as Cellegesic in the United States.

ProStrakan will be applying for further approvals of Cellegesic throughout the European Union under the Mutual Recognition Procedure, officials said.

Cellegesic is a Huntingdon Valley, Pa.-based specialty biopharmaceutical company focused on development of drugs for women's health care conditions.


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