AstraZeneca plc AZN received disappointing news with Amgen AMGN announcing its intention to terminate the co-development and commercialization agreement with AstraZeneca for brodalumab due to safety issues.
Amgen mentioned in its press release that the decision was based after safety concerns like suicidal ideation and behavior related to brodalumab were observed that could lead to restricted labeling, thereby affecting the commercial potential of the drug.
With the termination of this agreement for brodalumab, AstraZeneca will be solely responsible for the development and submission of marketing applications for brodalumab in all territories excluding certain Asian territories like Japan, where Kyowa Hakko Kirin has rights to brodalumab.
We note that AstraZeneca and Amgen had entered into a collaboration to jointly develop and commercialize five monoclonal antibodies from Amgen’s clinical inflammation portfolio in Apr 2012. While Amgen was responsible for the development and commercialization of brodalumab and AMG 557/MEDI5872 (phase Ib for autoimmune diseases like systemic lupus erythematosus), AstraZeneca, through its biologics arm MedImmune, handled the development and commercialization of MEDI7183/AMG181 (phase II for ulcerative colitis and Crohn’s disease), MEDI2070/AMG139 (phase II for Crohn’s disease) and MEDI9929/AMG 157 (phase II for asthma).
Brodalumab, an experimental interleukin-17 receptor inhibitor, is being developed for the treatment of patients suffering from moderate-to-severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Last November, the companies had reported positive phase III results on brodalumab in moderate-to-severe psoriasis patients and were working on regulatory filings in the U.S. and EU.
AstraZeneca, however, intends to decide on the future course of the drug after a thorough analysis of the data. The news of the termination is a disappointment for AstraZeneca which is looking to bring new products to market.
We note that the psoriasis market is extremely crowded given the presence of products like Stelara, Enbrel, Otezla and Cosentyx.
AstraZeneca currently carries a Zacks Rank #3 (Hold) while Amgen holds a Zacks Rank #2 (Buy). Some other well-placed stocks in the health care sector are Gilead Sciences Inc. GILD and Actelion Ltd. ALIOF. Both Gilead and Actelion are Zacks Rank #1 (Strong Buy) stocks.
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