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Fortesta

Kyowa Hakko Kirin Co., Ltd.

Drug Names(s): Fortigel, Tostrex (EU), Tostran, Itnogen, transdermal 2% testosterone gel

Description: Fortigel is a transdermal testosterone gel, utilizing a metered dose delivery system, for the treatment of male hypogonadism, a condition which afflicts up to 5 million men in the United States, primarily over the age of forty. Testosterone binds to the androgens receptors and exerts its cellular ad physiological effects.

Deal Structure: Cellegy, PDI and ProStrakan
In January 2003, Cellegy Pharmaceuticals and PDI entered into an exclusive licenseagreement to commercialize Fortigel in North American markets. Under the terms of the agreement, PDI will be responsible for themarketing and sales of Fortigel. Cellegy received a payment of $15 million on signing of the agreement on December 31, 2002 and will receive a milestone payment of $10 million. PDI will also make royalty payments on net sales ranging from 20% to 30%. Cellegy will be responsible for supplying finished product to PDI through its contract manufacturer. The agreement remains in effect for the full duration of the commercial life of the product.

In July 2004, Cellegy and ProStrakan Pharmaceuticals Limited entered intoan exclusive license agreement for the commercialization of Tostrex (European name) in Europe. Under the terms of the agreement, ProStrakan will be responsible for regulatory filings, sales, marketing and distribution of...See full deal structure in Biomedtracker

Partners: Endo International plc


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