The Medicines Co.'s Kengreal Backed for FDA Approval - Analyst Blog
The Medicines Company MDCO received encouraging news with the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voting in favor (9-2) of clearing the company’s intravenous antiplatelet agent, Kengreal (cangrelor). We expect investors to react positively to the news.
Kengreal is recommended to be approved as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization. The positive opinion rendered by the FDA panel was widely expected following the favorable briefing documents released by the FDA prior to the panel meeting (read more: The Medicines Co.'s Kengreal Briefing Documents Positive).
The favorable opinion of the CRDAC will now be reviewed by the FDA with a final response expected by Jun 23. With the CRDAC in favor of approving Kengreal, we believe chances of approval are high.
We remind investors that Kengreal gained EU (trade name: Kengrexal) approval in late March this year for the PCI indication.
The U.S. approval of Kengreal would be a huge positive for the company which is facing challenges for its key product Angiomax, which accounted for almost 83% of total revenues in the U.S. in 2014.
Earlier this month, the company announced disappointing preliminary first quarter revenue expectations of $125–$130 million with Angiomax expected to record a significant decline in revenues from the year-ago period. The decline is primarily due to customers’ current uncertainly regarding the product’s patent exclusivity in the U.S. after Jun 2015. The Medicines Co. will be reporting first quarter results on May 5.
The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AVEO Pharmaceuticals, Inc. AVEO, ANI Pharmaceuticals, Inc. ANIP and Horizon Pharma plc HZNP. All three are Zacks Rank #1 (Strong Buy) stocks.
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