PHARMACY

Report: CVS Caremark to merge PBM units

BY Antoinette Alexander

WOONSOCKET, R.I. CVS Caremark is looking to integrate the five units of its pharmacy benefit management division, a move it believes will improve internal processes, productivity and costs, according to a Bloomberg News report.

Per Lofberg, who has served as president of the PBM business since early January, told Bloomberg News that it will make a “substantial” investment to complete the integration of the information and database systems of the five PBM operations CVS has bought in recent years — Rx America, bought in 2008 along with Longs Drug Stores; Caremark Rx and PharmaCare division, part of the 2007 Caremark acquisition; and PCS Health Systems, along with its Advance PCS unit purchased in 2003.

“We are just in the first inning of an important initiative for us,” he told Bloomberg in a recent interview. “I see it as a big opportunity to improve our processes, productivity and costs. We have a lot more work ahead.”

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Watson seeks FDA approval for depression generic

BY Alaric DeArment

MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.

Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.

Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.

Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.

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Rituxan gets nod of approval from FDA

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.

The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”

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