CHMP Positive on Bristol-Myers/Pfizer's Eliquis for New Indication
Bristol-Myers Squibb Company (BMY) and partner Pfizer (PFE) announced that the European Medicines Agency’s (EMA.TO) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of their blood thinner Eliquis in the EU for an additional indication.
The CHMP issued a positive opinion regarding the approval of Eliquis for the treatment of deep vein thrombosis (DVT.V) and pulmonary embolism (PE) and for preventing recurrent DVT and PE in adults. The CHMP’s favorable opinion was based on positive results from two studies — AMPLIFY and AMPLIFY-EXT — on Eliquis. A final decision will be made by the European Commission after reviewing the CHMP’s recommendation.
The marketing application for the additional indication was accepted for review by the EMA in Nov 2013. We expect Eliquis, which is already approved for a couple of indications, to gain approval in the EU for the additional indication. We note that Eliquis is under review in the U.S. for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE (FDA target date: Aug 25, 2014). We expect investor focus to remain on the companies’ efforts to expand Eliquis’ label. Successful label expansion would boost the sales potential of the drug, which recorded modest sales of $106 million in the first quarter of 2014.
CHMP Delivers Yet Another Good News for Bristol-Myers
Bristol-Myers received further encouraging news from Europe when the CHMP adopted a positive stance on the approval of the company’s hepatitis C virus (:HCV) candidate, Daklinza (daclatasvir), in the EU. Bristol-Myers is looking to get Daklinza approved in the EU as a combination therapy for treating adults suffering from chronic HCV.
Bristol-Myers stated in its press release that Daklinza in combination with Gilead’s (GILD) HCV treatment Sovaldi (sofosbuvir) is already in use for treating more than 2,000 HCV patients with advanced liver disease through the early access program at Bristol-Myers.
Bristol-Myers is looking to get Daklinza-based regimens approved in the U.S. (target date: Nov 30, 2014) and Japan (decision expected shortly) for treating HCV. The HCV market offers significant commercial potential. Consequently, Bristol-Myers’ success in securing approval(s) for Daklinza-based regimens would boost its top line significantly.
Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). A better-ranked stock in the biopharma space is Regeneron Pharmaceuticals (REGN), sporting a Zacks Rank #1 (Strong Buy).
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