Mylan, Inc.
(
MYL
) recently announced a settlement agreement with
Novartis
(
NVS
) relating to the generic version of Novartis' bioidentical
estrogen therapy Vivelle-Dot. As a result of the resolution, the
lawsuit filed by Novartis will be dismissed and Mylan can launch a
generic version of Vivelle-Dot on December 16, 2013, or earlier
under certain circumstances.
Mylan was the first to file an abbreviated new drug application
(ANDA) with the US Food & Drug Administration (FDA) to market
the generic version of the drug. Accordingly, Mylan will enjoy an
exclusivity period of 180 days when it will be the sole company to
market the generic. The deal is subject to review by the US
Department of Justice and the Federal Trade Commission.
Earlier this month, Mylan entered into an agreement with
Pfizer, Inc.
(
PFE
) under which Pfizer will grant Mylan rights to its dry powder
inhaler delivery platform for the development and commercialization
of branded and generic pharmaceutical products. The agreement
grants exclusive global rights to Mylan to develop, manufacture and
commercialize Pfizer's generic version of
GlaxoSmithKline
's (
GSK
) respiratory drugs Advair Diskus and Seretide Diskus utilizing
this platform. These drugs are used for the treatment of asthma and
COPD (chronic obstructive pulmonary disorder). Mylan will make an
upfront payment of $17.5 million to Pfizer apart from additional
payments including regulatory and commercial milestones.
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, in the field.
GLAXOSMITHKLINE (
GSK
): 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
WATSON PHARMA (WPI): Free Stock Analysis Report
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