Amgen Inc. AMGN announced that it is looking to get its PCSK9 inhibitor, Repatha, approved in Japan. The company has submitted a marketing application for its cholesterol-lowering candidate to the Ministry of Health, Labour and Welfare in Japan.
We note that Amgen has a joint venture in Japan — Amgen Astellas BioPharma K.K. – with Astellas Pharma Inc. ALPMY for Repatha.
According to the National Institute of Health, there are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.
We note that Repatha is currently under review in the U.S. as well as the EU; a response in the U.S. should be out by Aug 27.
The cholesterol market is highly lucrative and represents huge commercial opportunity. According to the Centers for Disease Control and Prevention (CDC), 71 million adults in the U.S. have elevated levels of LDL-C in their blood. Despite the presence of several treatments, quite a few companies are working on bringing new and better treatments to market.
Apart from Amgen’s Repatha, another PCSK9 inhibitor currently under regulatory review is Praluent. Praulent could very well be the first PCSK9 inhibitor to gain approval in the U.S. with the FDA expected to take a decision by Jul 24.
Meanwhile, Amgen has several pipeline and regulatory events lined up this year. Other pipeline candidates currently under regulatory review include Corlanor (chronic heart failure). The company also plans to submit marketing applications for its moderate-to-severe plaque psoriasis candidate – brodalumab – in 2015. The company’s metastatic melanoma candidate – talimogene laherparepvec – is also set to be reviewed by an FDA advisory panel on Apr 29.
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Company, Inc. LCI and Cambrex Corp. CBM. Both companies hold a Zacks Rank #1 (Strong Buy).