) recently responded to the unfavorable ruling by the US District
Court for the Southern District of New York regarding the Copaxone
patent infringement case. Mylan said that it intends to appeal the
MOMENTA PHARMA (MNTA): Free Stock Analysis
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Despite the unfavorable ruling, Mylan maintained its guidance for
2012 and 2013 and said that its earnings guidance was not dependent
on the launch of a generic Copaxone.
The company reaffirmed its 2012 earnings guidance range of $2.45 to
$2.55 per share. The 2012 Zacks Consensus Estimate for earnings,
pegged at $2.50 per share, is in the middle of the guidance range.
Mylan also maintained its 2013 earnings target of $2.75 per share.
We expect that the company will be able to achieve this target.
On June 23, 2012,
Teva Pharmaceutical Industries Ltd.
) said that the court has ruled against
Momenta Pharmaceuticals, Inc.
)/Sandoz Inc. and Mylan/Natco Pharmaceuticals, who were seeking
approval for their generic versions of Copaxone.
The court ruled that the claims made by Momenta/Sandoz and
Mylan/Natco about the Copaxone patents being invalid and
unenforceable were unfounded. Moreover, the court ruled that the
generic versions for which the companies were seeking Food and Drug
Administration (FDA) approval would infringe the Copaxone patents.
Copaxone is approved for the reduction of the frequency of relapses
in relapsing-remitting multiple sclerosis (RRMS), including
patients who have experienced a first clinical episode and have MRI
features consistent with multiple sclerosis.
As of May 29, 2012, Mylan had 171 abbreviated new drug applications
(ANDAs) pending FDA clearance, targeting $84 billion in sales
annually. Mylan believes that about 38 of these ANDAs are
first-to-file opportunities, representing approximately $25.5
billion in branded sales. The revenue figures are as per IMS Health
for the 12 months ending December 31, 2011.
We are encouraged by Mylan's geographic reach and product depth
along with a robust generic product pipeline.
However, we are concerned about the company's lackluster
performance in the Europe, Middle East and Africa (EMEA) region.
Additionally, with most large branded drugs due to lose patent
exclusivity within the 2017-2018, we have little visibility on the
growth prospects for generic companies like Mylan beyond that
Thus, we prefer to remain on the sidelines and have a Neutral
recommendation on Mylan. The stock carries a Zacks #3 Rank (Hold
rating) in the short term.