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Jazz Pharmaceuticals plc

Drug Names(s): Samarium-153 Lexidronam Injection

Description: Quadramet (samarium Sm-153 EDTMP) is a short-range, beta-emitting therapeutic radiopharmaceutical consisting of radioactive samarium and a tetraphosphonate chelator. The drug has an affinity for bone, concentrating in areas of bone turnover in association with hydroxyapatite. In clinical studies, more Quadramet accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. The mechanism of action of Quadramet in relieving the pain of bone metastases is not known.

Deal Structure: In 1993, Cytogen acquired an exclusive license in the U.S. from the Dow Chemical Company for Quadramet. In connection with this acquisition, Cytogen issued to Dow warrants to purchase260,000 shares of the Company's common stock at $12.50 per share. Cytogen was required to pay Dow $1.0 millon within 30 days after the filing of an NDA with the FDA. Cytogen will also be required to pay $4.0 million to Dow if Quadramet receives FDA approval. The agreement provides for additional payments by Cytogen uponachievement of certain milestones and royalties on net sales of the product once commercialized, including guaranteed minimum payments.

Cytogen and Schering
In 1998, Berlex, a U.S. affiliate of Schering AG, and Cytogen entered an agreement under which Berlex acquired the marketing rights to Quadramet in North and South America. Under this agreement, Cytogen also receives royalties on product sales through Berlex.

In August 2003, Cytogen reacquired the marketing rights held...See full deal structure in Biomedtracker

Partners: Bayer AG

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