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news.Cellegy Pharmaceuticals has renegotiated the EU license and distribution agreement for its pain relief product, Rectogesic, with its licensee, ProStrakan Group.
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Rectogesic is a topical nitroglycerin ointment indicated for the relief of pain associated with chronic anal fissures. In September 2004, the product was approved by the UK Medicines and Healthcare Products Regulatory Agency for sale in the UK.
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.
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.
In December 2004, Cellegy and ProStrakan entered into an exclusive license agreement for the commercialization of Rectogesic (branded Cellegesic in the US) in Europe. In May 2005, the product was launched in the UK, by ProStrakan. ProStrakan will be applying for further approvals of Cellegesic throughout the EU, under the mutual recognition procedure.