Amgen ($AMGN) shocked the industry in May when it cut ties with an AstraZeneca ($AZN)-partnered psoriasis treatment after spotting alarming rates of suicidal thoughts among patients taking the antibody. But its former collaborator is remaining optimistic about the once-promising treatment, tentatively moving toward an FDA filing.
In its earnings presentation Thursday, AstraZeneca said it was still working through the rights transfer with Amgen but noted that a review of the data that spooked its ex-partner "confirms ... that the observations of suicidal ideation and behavior are unlikely to be causally related to brodalumab therapy."
Now the drugmaker is moving forward with "a full analysis" of those data, management said, all the while listening to pitches from would-be partners who want to help take brodalumab forward. The injected treatment is still slated for a 2015 regulatory filing on AstraZeneca's pipeline chart, albeit with an asterisk noting the company will make a final decision "in due course."
Amgen's exit from the brodalumab program clouded the future of a therapy once widely considered to be on the path to FDA approval and potential blockbuster sales. The antibody works by blocking a cytokine called interleukin 17, which plays a role in the inflammatory process behind psoriasis and other immunological disorders. In a trio of Phase III trials, the treatment successfully cleared up the plaques that mark psoriasis and beat out Johnson & Johnson's ($JNJ) Stelara. As recently as April, Amgen and AstraZeneca were talking up a mid-year FDA application with eyes on a 2016 launch.
Now, even if everything works out for AstraZeneca and its mystery future partner, brodalumab would likely face a crowded market for interleukin antibodies in inflammatory disease. Earlier this year, Novartis ($NVS) won FDA approval for its IL-17 blocker, Cosentyx, while Eli Lilly ($LLY) is pressing through Phase III with the similar ixekizumab, and Merck ($MRK) and J&J are developing separate IL-23 inhibitors.
- read the statement (PDF)