) 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
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
), 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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