Is Forest Labs' Nebivolol Ready for Prime Time?
By Billy Fisher
October 30, 2007
Since August, shareholders of Forest Laboratories (NYSE: FRX) have been looking for some way to boost a share price that is now floundering more than 30% below Forest's 52-week high attained back in February.
What could get shares to go back in the right direction would be FDA approval of Nebivolol, a selective beta 1-blocker for treating hypertension. On May 1, Forest announced that its licensing partner, Mylan Laboratories (NYSE: MYL), had submitted a response to the approvable letter issued by the FDA, and it expected the FDA to complete its review of Nebivolol's New Drug Application (NDA) within six months.
As the six-month mark approaches, I looked at the prospects for approval, and it is pretty good. Last month analyst Robert Uhl of Friedman, Billings, Ramsey Group (NYSE: FBR) voiced his expectation that the FDA would approve two hypertension treatments from Forest -- Azor and Nebivolol -- before the close of 2007. Forest management is also fairly confident the drug will be approved. Nebivolol has been successfully approved and marketed in 50 countries outside the U.S. and has produced compelling clinical trial results that were published in the September issue of Journal of Clinical Hypertension.
It's true that 2007 has been one of the toughest years in recent times to receive FDA approvals on NDAs. But based on the clinical trial results published in Journal of Clinical Hypertension, I would say this drug is good to go. In the double-blind, placebo-controlled study that enlisted more than 900 subjects, Nebivolol demonstrated the ability to significantly reduce sitting diastolic and systolic blood pressure with side effects that were mild and minimal.
The verdict should be in any day now. An approval is important for Forest; its biggest seller, antidepressant Lexapro, goes off patent in 2012, and the company recently had to fend of a challenge by Teva Pharmaceuticals (Nasdaq: TEVA) to undercut Lexapro with a generic version.
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