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.
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.
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