PHARMACY

Regulus Theraputics names Xanthopoulos president and CEO

BY Adam Kraemer

NEW YORK Kleanthis Xanthopoulos has been named president and chief executive of Regulus Therapeutics, a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals

The joint venture focuses on microRNA technology, which controls protein production within cells and could be used to turn off certain genes, in effect treating a condition at the genetic level.

Xanthopoulos is co-founder, former president and chief executive officer of Anadys Pharmaceuticals, a company focusing on the development of novel medicines for the treatment of hepatitis C and cancer. and most recently was managing director of Enterprise Partners Venture Capital.

He participated in the National Institutes of Health Human Genome Project and was a section head of the National Human Genome Research Institute at NIH from 1995 to 1997.

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Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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