Mylan Inc. (
) recently announced that its UK and Italian subsidiaries have
launched its generic version of
) osteoporosis drug, Bonviva (ibandronic acid), 150 mg. Bonviva is
a coated tablet with a once-monthly recommended dosing.
According to IMS Health, Bonviva generated revenues of
approximately €8.5 million and €27 million in the UK and Italy
respectively, for the 12 months ending March 2012. We note that
Mylan derives 23.8% of its generic revenues from the Europe, Middle
East and Africa (EMEA) region. It has a robust portfolio in this
region which includes 350 products and 340 products in the UK and
Meanwhile, in the U.S., Mylan recently received final approval
from the Food & Drug Administration (FDA) for its generic
version of Boehringer Ingelheim's Viramune (nevirapine).
Viramune is approved for HIV-1 infection in combination with
antiretroviral (ARV) treatment. According to IMS Health, Viramune
generated U.S. revenues of approximately $116.6 million for the 12
months ending March 31, 2012.
Just a few days ago, Mylan received final approval from the FDA
to launch its generic versions of Plavix (clopidogrel), 75 mg and
300 mg. Plavix is sold by
Bristol-Myers Squibb Co.
) and is approved for patients who have had a heart attack or
stroke recently, or suffer from a partial or total blockage of an
artery (peripheral artery disease).
According to IMS Health, Plavix generated U.S. revenues of
approximately $6.7 billion for the 12 months ending March 31,
As of May 23, 2012, the company had 173 abbreviated new drug
applications (ANDAs) pending clearance by the FDA, targeting $92
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 Dec. 31,
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 EMEA
Additionally, with most large branded drugs due to lose patent
exclusivity within 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.
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