A subsidiary of Mylan Inc. (MYL) recently received approval for marketing Sumatriptan Succinate Tablets from the US FDA. This generic version of GlaxoSmithKline’s (GSK) Imitrex is meant for the treatment of migraine and headache. The drug had recorded total US sales of about $934 million in the 12 months ended June 30. But Mylan is a late entrant in this segment as Dr Reddy’s Laboratories (RDY) became the first to launch a generic version of the drug last November.
Mylan is now the third-largest generic company in the world after the acquisition of Merck Generics and Matrix Labs. We expect the Merck Generics acquisition to contribute significantly to Mylan’s long-term growth and the help the company expand its footprints in non-U.S. markets.
At present, the company has 120 abbreviated new drug applications (ANDAs) that are awaiting FDA approval, targeting approximately $85.6 billion in branded sales. Among these, Mylan believes 34 are first-to-file opportunities, representing about $17.3 billion in annual brand sales. The company is looking to launch nearly 24 new products in the US in the remainder of 2009 and another 45 in 2010.
Another significant opportunity for Mylan could be the launch of a generic version of Teva’s (TEVA) Copaxone. In June 2008, Mylan signed a license and supply agreement with India’s Natco Pharma Ltd. for glatiramer acetate pre-filled syringes, a generic version of Teva’s multiple sclerosis treatment. The agreement grants Mylan exclusive distribution rights in the U.S. and all major markets in Europe, Australia, New Zealand, Japan and Canada and includes an option to expand its sales into other markets.
The company is looking to file an ANDA for generic Copaxone shortly. While the US launch is not likely to take place before 2011, Mylan is looking to launch the product in other territories in 2010. We have a Neutral recommendation on the stock.
Read the full analyst report on “MYL”
Read the full analyst report on “RDY”
Read the full analyst report on “TEVA”
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