Amgen pulls out of psoriasis deal with AstraZeneca
pharmafile | May 26, 2015 | News story | Sales and Marketing | Amgen, AstraZeneca, psoriasis
Amgen has ended its agreement with AstraZeneca to develop a new biologic for psoriasis, because of the likelihood of ‘restrictive labelling’ due to the drug’s potential risk of suicidal thoughts.
The two companies had been jointly developing brodalumab, an investigational IL-17 inhibitor, for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
Yet Amgen ended the companies’ agreement with respect to the drug emerged in the run-up to the drug being submitted to the FDA. It felt that the evidence of a potential risk of behaviour changes and suicidal thoughts that had emerged during clinical could result in labelling warnings that would be too ‘restrictive’ for the company to make a profit from bringing it to market.
“During our preparation process for regulatory submissions, we came to believe that labelling requirements likely would limit the appropriate patient population for brodalumab,” says Sean Harper, executive vice president of R&D at Amgen. In a statement Amgen says it “has decided to focus its efforts and resources on other key molecules”.
Brodalumab had been painted as a possible blockbuster by AstraZeneca, which projected up to $1.5 billion a year in revenue. But Amgen insists pulling out of the deal so close to the FDA submission will not affect it financially, saying the firm “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”.
The late about-turn by Amgen comes as a surprise to many. As recently as April, when Amgen reported its first quarter financial results for the year, the firm said it had “noted that we have seen suicidal ideation and completed suicides in our brodalumab program, but that we believe the evidence to date does not suggest a causal association between IL-17 inhibition and suicidal ideation and behaviour”.
However the company had previously terminated Phase II studies of brodalumab in asthma ‘due to futility’.
The collapse of the deal comes at a critical time for both companies. Amgen recently won a positive FDA committee vote for its cancer drug Vectibix (panitumumab), while Corlanor (ivabradine) was approved as a new heart therapy in April.
But Vectibix is dogged by reports of severe side effects, and Corlanor is expected to be swiftly bypassed by Novartis’ big blockbuster hopeful, the heart failure drug LCZ696. Meanwhile AstraZeneca is behind its psoriasis rival Novartis, which had its IL-17 inhibitor Cosentyx (secukinumab) approved by the FDA in January.
AstraZeneca says it will make a decision on whether to continue the development of brodalumab soon, based on further review of the data.
Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca, says: “Data from the three AMAGINE Phase III studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit. We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine.”
AstraZeneca now has sole responsibility for brodalumab globally except in Japan, where Kyowa Hakko Kirin has rights to the drug.
Lilian Anekwe
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