FDAnews
www.fdanews.com/articles/172966-valeant-acquires-rights-to-azs-brodalumb

Valeant Acquires Rights to AZ’s Brodalumb

September 8, 2015

Valeant Pharmaceuticals will pay up to $445 million for the rights to AstraZeneca’s investigational psoriasis drug brodalumab, which is set for regulatory submissions in the U.S. and EU in the fourth quarter.

The agreement calls for Valeant to pay $100 million upfront, prelaunch milestones of up to $170 million and sales-related payments of up to $175 million following brodalumab’s launch. AZ and Valeant will share future profits on the drug.

Valeant will hold exclusive rights to market brodalumab globally, except in Japan and other Asian countries where rights are held by Kyowa Hakko Kirin under a deal with Amgen, which originated the drug. The deal is expected to close by the end of the year.

Amgen announced in May that it was terminating its relationship with AZ to develop the drug over concerns that potential behavioral issues, including suicidal thoughts, would lead to restrictive labeling and limit the use of brodalumab.

In three Phase 3 trials, a significant number of patients with moderate-to-severe psoriasis who received brodalumab achieved total clearance of their skin disease, AZ says. Two of the studies also showed the drug outperformed Janssen’s Stelara (ustekinumab) and a placebo at week 12. — John Bechtel