An FDA "approvable" letter citing deficiencies at a backup manufacturing facility may be all that stands between Forest and Mylan's nebivolol and approval. The firms say they will take the novel beta blocker for hypertension to market in early 2008, as previously announced, under the brand name Bystolic .

FDA's letter does not raise any questions about the drug's safety or efficacy, and the companies report they have agreed with FDA on product labeling.

Forest, which licensed the beta blocker from Mylan in January 2006, plans a January 2008 launch meeting for the drug. Mylan, mainly involved in production of generics, has an option to co-promote the drug in the future.

FDA's concerns with a backup manufacturing facility in Belgium are seen as minor and the companies say they plan to address those outstanding issues shortly.

While Bystolic will be competing with generic versions of established beta blockers that already have gone generic, Forest and Mylan believe it will have a competitive advantage in its low sedation level. Many high blood pressure patients eventually stop taking currently available beta blockers because of the fatigue they can cause, the firms claim.

The approvable letter is the second for nebivolol. In May, the companies responded to an FDA inquiry with additional data they described as pharmacological in nature, small and of short duration (¹ Also see "Forest/Mylan Respond To FDA “Approvable” Letter On Nebivolol" - Pink Sheet, 1 May, 2007.). At the time, they also noted nebivolol is approved and marketed for hypertension in 50 countries.

In a Dec. 3 note, JP Morgan analyst Adam Greene predicted the drug is on track for full approval and launch in early 2008. Noting the current U.S. market for beta blockers is $2.1 billion, or about 132 million prescriptions annually with growth at about 2 percent, Greene projected Bystolic could generate sales of $15 million in the first quarter of 2008 and $130 million in its first full year.

Cowen analyst Ian Sanderson wrote Dec. 3 that Forest's stock will face some sell pressure in the short term due to the approvable letter, but the fundamental outlook for the stock remains positive. "We continue to believe [Forest's] shares can outperform the market by 15%+ as pipeline visibility improves over the next 12-15 months," Sanderson said.

After the drug is approved for hypertension, Forest is planning a second NDA for nebivolol, with an indication of congestive heart failure (² Also see "Forest Will Delay Nebivolol NDA For CHF Pending FDA Review Of Hypertension Data" - Pink Sheet, 16 January, 2007.).

-Joseph Haas (j.haas@elsevier.com)

Forest And Mylan Confident Nebivolol Will Reach Market In Early 2008

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