Deal supersedes previous co-promotion arrangement inherited from Procter & Gamble Pharmaceuticals.

Novartis has sold the U.S. marketing rights to its overactive bladder drug, Enablex® (darifenacin) extended-release tablets, to Ireland-based specialty medicines company Warner Chilcott for $400 million in cash. The deal supersedes the firms’ previous U.S. co-promotion agreement for Enablex, which Warner Chilcott had essentially acquired when it bought Procter & Gamble Pharmaceuticals (PGP) from Procter & Gamble in 2009.

Novartis could receive up to another $20 million in milestones under terms of the new deal, and the firm retains rights to darifenacin in the rest of the world. Warner Chilcott has sole rights to Enablex in the U.S, and will manufacture the drug for the U.S. market at its own facility once the production process has been transferred from Novartis. The firm says sales of Enablex in the U.S. reached approximately $190 million in the year ended December 31, 2009.

“This is an important step in expanding our presence in one of our key therapeutic segments,” comments Roger Boissonneault, Warner Chilcott’s president and CEO. “The acquisition of the U.S. rights to Enablex bolsters our franchise in the urology segment, provides us with greater control in promoting the product, and demonstrates our ability to successfully add complementary assets to an already strong product portfolio.”

Procter & Gamble’s branded pharmaceuticals business Procter & Gamble Pharmaceuticals had been Novartis’ codevelopment and copromotion partner for Enablex in the U.S., under terms of an agreement signed back in 2005. This partnership was effectively transferred to Warner Chilcott in October 2009 when it acquired PGP from Procter & Gamble for $3.1 billion in cash.

Under the terms of the inherited copromotion agreement for Enablex, Warner Chilcott and Novartis shared the development and promotion costs relating to the U.S. Enablex business, and Warner Chilcott only received a contractual percentage of Novartis’ sales of the drug in the U.S. The company was in addition obligated to pay a predetermined yearly amount in relation to advertising, promotion, and selling.

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