Acorda Therapeutics, Inc. announced that the US District Court for the District of New Jersey has ruled against it in its patent litigation against Apotex Corporation and Apotex, Inc. The Court held that the claims of US Patent No. 6,455,557 covering use of multi-particulate tizanidine compositions are invalid and not infringed by Apotex Corporation and Apotex, Inc. The litigation began in 2007, based on Apotex, Inc.'s submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) seeking marketing approval for generic versions of three dosage strengths of Zanaflex capsules (tizanidine hydrochloride). The company is evaluating its options, including a potential appeal of the decision.

“While we are disappointed with the ruling from the Court and will consider our options, it's important to recall that our acquisition of the Zanaflex franchise in 2004 was intended to help fund the development of our commercial capabilities in the specialty neurology space,” said Ron Cohen, MD, Acorda Therapeutics' president and CEO. “We not only achieved this, but were able to grow the franchise well beyond even the most optimistic expectations at the time. Thanks in part to this strategy, in 2010 we were able to launch Ampyra successfully in the US. Since then, the key value drivers for Acorda have been, and continue to be, growing Ampyra, advancing our existing product pipeline and potentially acquiring additional clinical and commercial products.”

Net sales of Zanaflex capsules and Zanaflex (tizanidine hydrochloride) tablets were $23.3 for the first half of 2011 and $48.5 million in 2010.

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders.