Shire, New River Collaborate on ADHD Drug Candidate

Shire Pharmaceuticals Group and New River Pharmaceuticals have signed an agreement for the global commercialization of NRP104, New River's Phase III compound for treatment of attention-deficit/hyperactivity disorder (ADHD), as well as for other potential indications.

Under the terms of the agreement the parties will collaborate on NRP104 development, manufacturing, marketing and sales in the U.S. Shire will book the product sales and New River may supply up to 25 percent of the sales effort under a co-promotion right. New River will be financially and operationally responsible for clinical and manufacturing development.

Upon FDA approval, the parties will divide operating profit in accordance with the following general principles: Shire will retain 75 percent of profits for the first two years following launch and the parties will share the profits equally thereafter.

In the rest of the world, Shire has a license to develop and commercialize NRP104 and New River will receive a low double-digit royalty on net sales.

Shire pays an initial sum of $50 million on signing, a further $50 million upon acceptance of filing of the new drug application by the FDA and up to $300 million in milestone payments depending on the characteristics of the FDA-approved product labeling. An additional $100 million milestone would be payable as a sales bonus upon achieving a significant sales target.