Forest Laboratories, Inc.
) recently presented positive topline data on its hypertension
drug, Bystolic (nebivolol) when used in combination with
valsartan. The 8-week randomized, double-blind,
placebo-controlled phase III study was conducted to evaluate the
efficacy and safety of a fixed dose combination (FDC) of Bystolic
and valsartan for the treatment of hypertension.
Results showed that treatment with the Bystolic-valsartan
combination resulted in statistically significant reductions in
diastolic blood pressure compared to Bystolic alone and valsartan
alone. In addition to meeting the primary endpoint, the
Bystolic-valsartan combination met the main secondary endpoint of
change from baseline in systolic blood pressure.
Based on these positive results, Forest Labs intends to seek
FDA approval for the combination treatment in the first quarter
of calendar 2014.
Bystolic is a key product in Forest Labs' portfolio. Bystolic
turned in sales of $455 million in fiscal 2013, up 30.8%.
Bystolic sales are expected to grow 17.6% to $535 million in
We are encouraged by Forest Labs' efforts to extend the
product's lifecycle by bringing a fixed dose combination of
Bystolic and valsartan to market. A fixed dose combination
product would expand the patient population for Bystolic.
Forest Labs currently carries a Zacks Rank #3 (Hold). The
company is facing tough times with Lexapro losing patent
protection. Moreover, the performance of new products, especially
Teflaro, has been below expectations. We also remain concerned
about rising expenses.
However, we remain encouraged by Forest Labs' progress with
its pipeline candidates. Forest Labs has been pretty successful
in gaining regulatory approval for several products over the last
few years and has an important regulatory event coming up with
the FDA slated to respond on the company's marking application
Companies that currently look well-positioned include
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