Amgen和AZ宣布结束银屑病和银屑病关节炎药物brodalumab的开发合作

Amgen和AZ宣布结束银屑病和银屑病关节炎药物 brodalumab的开发合作，原因是患者用药后出现自杀倾向。AZ已经决定终止开发和上市申请工作。至2012年以来药物的开发成本两家公司将分摊。这对AZ之前夸下的2023年销售额450亿美元销售额来说是个打击。

Amgen Ends Drug Pact With AstraZeneca After Signs of Suicide

Amgen Inc. ended a pact with AstraZeneca Plc to develop an experimental drug for psoriasis and psoriatic arthritis after patients showed signs of considering suicide.
AstraZeneca is deciding whether to end development or move forward with the drug, which the companies were in the process of submitting to the U.S. Food and Drug Administration.
The companies had been splitting costs of developing the drug, called brodalumab, since 2012. Amgen said in a statement Friday that it would end the partnership because the warning labels on the drug would limit who would use it. Analysts had projected that AstraZeneca would get $811 million from brodalumab in 2023.
“We came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab,” Sean Harper, executive vice president of research and development at Amgen, said in the statement.
During clinical trials, Thousand Oaks, California-based Amgen said that there were “events of suicidal ideation and behavior in the brodalumab program.” Brodalumab is being developed for moderate-to-severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.
In a separate statement, AstraZeneca said it was reviewing data on the drug. “AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible,” the London-based drugmaker said.
If AstraZeneca abandons brodalumab, it will be a blow to the drugmaker’s promise of $45 billion in revenue by 2023. In a long-range sales forecast issued a year ago when the drugmaker was fighting off a takeover attempt by Pfizer Inc., it cited $500 million to $1.5 billion in peak sales of the drug.
Drug Partnership
The collaboration began three years ago, when the companies agreed to work together to develop five drugs in Amgen’s pipeline. AstraZeneca initially paid Amgen $50 million, and agreed to fund 65 percent of the cost of the drugs from 2012 to 2014. After that, they planned to split costs and profits, the companies said in a joint statement at the time.
Brodalumab targets pathways that cause inflammation. It belongs to a class of drugs aimed at the interleukin-17, or IL-17, receptor.
Eli Lilly & Co.’s ixekizumab, which awaiting FDA approval for plaque psoriasis, and Novartis’s Consentyx, approved in the U.S. in January, also act on the IL-17 pathway, though at a different point.