FDA Nod for Merck Drug Label Update - Analyst Blog

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Merck ( MRK ) recently announced that the U.S. Food and Drug Administration (FDA) approved a label update for its HIV therapy, Isentress. The FDA has allowed Merck to update Isentress' label so that 156-week data from the ongoing STARTMRK study may be included.

The multi-center, double-blind, randomized, active-controlled, phase III non-inferiority STARTMRK study is comparing Isentress combination therapy to efavirenz combination therapy in treatment-naïve HIV 1 patients. Results showed that patients in the Isentress arm experienced long-term viral suppression and a greater immunologic response at 156 weeks with a proven safety and tolerability profile.

Isentress is currently approved for the treatment of HIV-1 in adult and pediatric patients (2 years and above) in combination with other antiretroviral (ARV) agents. While Isentress is approved in more than 45 countries for use in treatment-naïve adult patients, it is approved in more than 90 countries for use in treatment experienced adult patients.

FDA approval for the pediatric indication (children two years and older and weighing at least 10kg) came earlier this year in January. Isentress sales came in at $1.4 billion in 2011 - label expansions and launches in additional countries should help drive sales further. Other players in the HIV market include Gilead ( GILD ) and Bristol-Myers Squibb ( BMY ), among others.

Neutral on Merck

We currently have a Neutral recommendation on Merck, which carries a Zacks #3 Rank (short-term Hold rating). Merck is currently facing issues such as the patent expiration of key drug, Singulair and the Remicade/Simponi transition.

We believe the company will continue resorting to cost-cutting initiatives to drive the bottom-line. Meanwhile, some of the company's recent launches should start contributing significantly to the top line in the forthcoming quarters.


 
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: BMY , GILD , MRK

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