Mylan Launches Bonviva Generic - Analyst Blog


Mylan Inc. ( MYL ) recently announced that its UK and Italian subsidiaries have launched its generic version of Roche Holding's ( RHHBY ) 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 Italy, respectively.

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. ( BMY ) and Sanofi ( SNY ) 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, 2012.

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, 2011.     

Our Recommendation

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 region.

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 timeframe.

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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: BMY , MYL , SNY

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