Forest Laboratories, Inc. (FRX) has submitted a regulatory application for its fixed dose combination of Bystolic and Novartis’ (NVS) Diovan (valsartan) to the U.S. Food and Drug Administration (FDA). Forest Labs is looking to get the combination approved for the treatment of hypertension.
The company submitted the New Drug Application (NDA) on the basis of encouraging data from an 8-week randomized, double-blind, placebo-controlled phase III study (n = 4,161) which evaluated the efficacy and safety of different fixed combinations of Bystolic (5, 10, and 20 mg) and Diovan (80, 160, and 320 mg). The NDA also includes data from a 52-week, open-label safety/tolerability study.
Bystolic is a key product in Forest Labs’ portfolio. The product posted sales of $386.7 million in the nine months ended Dec 31, 2013, up 19.7% reflecting price increases and modest volume growth.
We are encouraged by Forest Labs’ efforts to extend the product’s lifecycle by bringing a fixed dose combination of Bystolic and Diovan to the market. A fixed dose combination product would expand the patient population for Bystolic.
Last month, Actavis, Inc. (ACT) announced its intention to acquire Forest Labs. The companies have signed a definitive agreement under which Actavis will acquire Forest Labs for a cash and equity transaction valued at about $25 billion. The deal is expected to close in mid-2014. Post-closure, Forest Labs’ shareholders will own 35% of the new company.
Forest Labs and Actavis both carry a Zacks Rank #2 (Buy). Other well-ranked stocks include Shire (SHPG) carrying a Zacks Rank #1 (Strong Buy).
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