Generic maker,
Mylan Inc
. (
MYL
) recently announced that its Indian subsidiary Mylan Laboratories
has received tentative approval from the US Food & Drug
Administration (FDA) for a fixed-dose combination of generic
versions of
Bristol Myers Squibb
's (
BMY
) drug Reyataz and
Abbott
Labs
' (
ABT
) Norvir for the treatment of HIV/AIDS. The fixed drug combination
has been pre-qualified to be used in treatment of experienced
patients by the World Health Organization (WHO). It can also be
used in combination with other antiretroviral (ARV) agents and will
be eligible for purchase in certain developing countries. The drug
was approved through the President's Emergency Plan for AIDS Relief
(PEPFAR). The drug will boost Mylan's already strong portfolio of
ARV's in India.
In a separate development, Mylan announced that
Warner Chilcott Company
(
WCRX
) filed a patent infringement lawsuit in connection with the
abbreviated new drug application (ANDA) filed by Mylan and partner
Famy Care Ltd. with the FDA for the generic version of Warner
Chilcott's oral contraceptive Generess Fe. Mylan believes it is the
first company to file an ANDA for generic Generess Fe with the hope
of being granted 180 days of marketing exclusivity once approved.
Mylan has a partnership with Famy Care Ltd. for the development and
supply of oral contraceptives.
Mylan also recently launched the generic version of
Pfizer
's (
PFE
) hypertension tablets, Caduet. The branded drug recorded sales of
$339 million for the trailing twelve months ended on September 30,
2011.
Our Recommendation
We currently have a Neutral long-term recommendation on Mylan.
The shares carry a Zacks #3 Rank (short-term Hold rating). Mylan is
one of the leading players in the US generics market. We are
encouraged by the company's geographic reach and product depth
along with its robust generic product pipeline. Nevertheless, we
are concerned about lackluster growth in the European generics
business. We intend to remain watchful until better visibility is
obtained on top-line growth prospects in Europe.
Moreover, competition in the generic segment is strong with
players like
Teva Pharmaceuticals
(
TEVA
),
Watson Pharma
(
WPI
) and Sandoz, the generics arm of
Novartis
(
NVS
), in the field.
ABBOTT LABS (
ABT
): Free Stock Analysis Report
BRISTOL-MYERS (
BMY
): Free Stock Analysis Report
MYLAN INC (
MYL
): Free Stock Analysis Report
NOVARTIS AG-ADR (
NVS
): Free Stock Analysis Report
PFIZER INC (
PFE
): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis
Report
WARNER CHIL PLC (WCRX): Free Stock Analysis
Report
WATSON PHARMA (WPI): Free Stock Analysis Report
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