CEPH Cephalon (MM)

MylanInc. (MYL) recently launched its generic version of Ista Pharmaceuticals Inc’s (ISTA) Xibrom ophthalmic solution, used for the treatment of inflammation in patients who have undergone a cataract extraction operation. The generic has been launched under a development and supply agreement with Coastal Pharmaceuticals. The branded product recorded sales of $116 million in US for the twelve months ending on March 31, 2011.

Mylan also recently announced launches of generic versions of Cephalon’s (CEPH) Amrix which is a muscle relaxant and Johnson & Johnson’s (JNJ) Risperdal which is used for the treatment of schizophrenia.

As of May 16, 2011, the company had 169 abbreviated new drug applications (ANDAs) pending US Food and Drug Administration (FDA) approval targeting $100.7 billion in branded sales. Mylan believes that about 45 of the pending ANDAs are first-to-file opportunities representing more than $25.8 billion in branded sales.

Our Recommendation

We currently have a Neutral 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. The company holds immense potential as many blockbuster drugs are slated to lose patent exclusivity in the forthcoming period. We are encouraged by Mylan’s robust generic product pipeline. However, competition in the generic segment is strong with players like Teva Pharmaceuticals (TEVA), Watson Pharma (WPI), Par Pharmaceuticals (PRX) and Sandoz - the generics arm of Novartis (NVS) - in the field. We also remain concerned about the lack of growth in the European generics business. We intend to remain watchful until we get better visibility on top-line growth prospects in Europe.

 
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