Under the terms of the agreement, the parties will collaborate on NRP104 development, manufacturing, marketing and sales in the US. Shire will book the product sales and New River may supply up to 25% 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, Shire will retain 75% of profits for the first two years following launch and the two companies 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 will pay 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 will be payable as a sales bonus upon achieving a significant sales target.
“This is a strong addition to our ADHD portfolio and complements the development strategy of Shire and its pipeline,” commented Matthew Emmens, chief executive of Shire. “NRP104 is in late stage development and we are encouraged by the data that we have seen to date and hope that the new drug has similar efficacy of currently marketed ADHD treatments with potential additional advantages.”