PHARMACY

Michael Sweeney appointed Depomed vp of product development

BY Adam Kraemer

MENLO PARK, Calif. Depomed, a pharmaceutical company specializing in controlled release oral medications, announced that Michael Sweeney has joined the company as vice president of product development.

Sweeney will implement Depomed’s strategic plan for product development activities, from opportunity assessment through clinical trials and interactions with the Food and Drug Administration and oversee several key functional areas, including formulations, pharmacokinetics, pre-clinical, clinical development and regulatory affairs. He also will be responsible for the commercial medical affairs function at Depomed.

Depomed has two approved products on the market and other product candidates in its pipeline. GLUMETZA (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and ProQuin XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections. Product candidate Gabapentin GR is currently in clinical development for the treatment of two pain indications.

“Mike brings extensive experience in overall product strategy and commercialization planning and will be a strong addition to the Depomed leadership team,” stated Carl A. Pelzel, president and chief executive officer of Depomed. “Mike’s skills in the identification, evaluation and planning of product development will allow him to play a critically important role in advancing our progress toward additional commercialized products.” 

Sweeney has more than 19 years of experience in product development and marketing of pharmaceutical products. Before joining Depomed, he was vice president of medical affairs at cv therapeutics, where he built the medical affairs department to enable the commercial preparation and successful launch of Ranexa in 2006. Prior to CV Therapeutics, he spent 11 years at Pfizer Pharmaceuticals in New York and the U.K.

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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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