Amgen To Terminate Participation In Co-development Of Brodalumad

(RTTNews) - Amgen (AMGN) on Friday said it has commenced termination of its participation in the co-development and commercialization of investigational plaque psoriasis drug brodalumab with AstraZeneca (AZN, AZN.L).

Amgen said the decision was based on events of suicidal ideation and behavior in the brodalumab program, which it believes would likely necessitate restrictive labeling.

Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.

"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Sean Harper, executive vice president of Research and Development at Amgen.

Amgen noted that after it transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.

Amgen said it has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The company said it continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.

In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio, including brodalumab.