stock gained 1.5% Thursday after the company announced the
Food & Drug Administration
accepted its new drug application for nebivolol, a highly selective beta-1 blocker used to treat hypertension.
In reaction to the news, shares of the company rose 31 cents to $20.56, reversing a slide that began last week, when the company said it will sue the Food and Drug Administration over the approval of a pain relief drug and suspended annual earnings guidance as a result. From June 22 until Wednesday's close, shares of the company had fallen 10%.
"Based on the clinical trial data to date, we believe that nebivolol shows great promise as a valuable treatment for hypertension," said Robert Coury, CEO and vice chairman. "Now that our nebivolol submission has been accepted by the FDA, we are excited to begin the review and approval process, and look forward to the addition of this exciting proprietary product to our growing brand franchise."
The nebivolol application includes data from previously released clinical studies of more than 2,000 patients that showed nebivolol lowered the blood pressure in patients who took it once daily, regardless of age, race or gender. The company filed the NDA at the end of April and said the FDA will issue its recommendation by the end of February 2005.
The FDA's acceptance of Mylan's NDA is a big step for the company, which is betting that the hypertension treatment can boost earnings in the coming years. When the company announced record fiscal 2003 earnings at the end of May, the company said it was committed to growing earnings by 15% annually over the long-term, telling investors its "recently-filed NDA for nebivolol, when approved, will provide a strong foundation for our branded business."