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 fiscal 2014.
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 for levomilnacipran.
Companies that currently look well-positioned include Jazz Pharmaceuticals (JAZZ - Analyst Report), Salix Pharmaceuticals and Santarus, Inc. .