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BioMarin-Dr. Reddy's Agree to Settle Kuvan Patent Litigation

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BioMarin Pharmaceutical Inc. (BMRN - Free Report) announced that it has entered into a settlement agreement with Dr. Reddy's Laboratories Ltd. (RDY - Free Report) to resolve the patent litigation related to Kuvan (sapropterin dihydrochloride 100 mg).

As per the terms of the settlement, Dr. Reddy's will receive a non-exclusive license to patents related to Kuvan allowing it to market a generic version of Kuvan for the treatment of patients suffering from phenylketonuria (PKU) in the U.S. While no specific launch date was mentioned, it is expected to be after five years or earlier under certain circumstances.

We note that Par Pharmaceutical is also looking to bring its generic version of Kuvan to market. A patent infringement lawsuit has been filed against Par. Kuvan sales came in at $110.3 million in the first half of 2015. BioMarin expects net sales of Kuvan in the range $210 million – $230 million in 2015.

Meanwhile, BioMarin continues to progress with its pipeline. Currently, the company is evaluating pegvaliase in phase III for the treatment of patients with PKU. Moreover, the company’s lead pipeline candidate, drisapersen, is under FDA review with a response expected by Dec 27. BioMarin is seeking approval for drisapersen for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping.

BioMarin carries a Zacks Rank #3 (Hold). Some better-ranked stock in the health care sector  includes Medivation, Inc. and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).

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