Amgen is dissolving an agreement with AstraZeneca to develop the psoriasis drug brodalumab after a patient involved in a late-stage trial developed suicidal thoughts and behavior, according to BioSpace.com.
Because of that incident, if the drug were eventually approved by regulators, they would likely require restrictive labeling, which discouraged Amgen. The latest news came as a major disappointment to both companies, after brodalumab showed strong results in terms of safety and in eliminating the skin disease.
The companies had predicted the drug could eventually earn between $500 million and $1.5 billion in sales annually.
“During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab,” says Sean E. Harper, executive vice president of research and development for Amgen, in a statement. The company said it would no longer be involved in the development of brodalumab, though there was some indication AstraZeneca may continue the program, BioSpace.com notes.
“After Amgen 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,” according to another Amgen statement.
Source: BioSpace.com
