Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S.
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 U.S. Patent No. 6,455,557 covering use of
multiparticulate 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 U.S. 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, M.D., 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 U.S. 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.
About Acorda
Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for
multiple sclerosis, spinal cord injury and related nervous system
disorders. The Company is commercializing and marketing AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the Unites
States. AMPYRA is a potassium channel blocker approved as a treatment to
improve walking in patients with multiple sclerosis (MS); this was
demonstrated by an improvement in walking speed. AMPYRA was developed
using Elan’s Matrix Drug Absorption System (MXDAS®)
technology and is manufactured by Elan based on a supply agreement with
Acorda.
Acorda also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride), a short-acting drug
for the management of spasticity. The Company's pipeline includes a
number of products in development for the treatment, regeneration and
repair of the spinal cord and brain.
Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects should be
considered forward-looking. These statements are subject to risks and
uncertainties that could cause actual results to differ materially,
including Acorda Therapeutics' ability to successfully market and sell
Ampyra in the United States and to successfully market Zanaflex
Capsules; third party payors (including governmental agencies) may not
reimburse for the use of Ampyra at acceptable rates or at all and may
impose restrictive prior authorization requirements that limit or block
prescriptions; the risk of unfavorable results from future studies of
Ampyra; the occurrence of adverse safety events with our products;
delays in obtaining or failure to obtain regulatory approval of Ampyra
outside of the United States and our dependence on our collaboration
partner Biogen Idec in connection therewith; competition; failure to
protect Acorda Therapeutics’ intellectual property, to defend against
the intellectual property claims of others or to obtain third party
intellectual property licenses needed for the commercialization of our
products; the ability to obtain additional financing to support Acorda
Therapeutics' operations; and, unfavorable results from our research and
development programs. These and other risks are described in greater
detail in Acorda Therapeutics' filings with the Securities and Exchange
Commission. Acorda Therapeutics may not actually achieve the goals or
plans described in its forward-looking statements, and investors should
not place undue reliance on these statements. Forward-looking statements
made in this release are made only as of the date hereof, and Acorda
Therapeutics disclaims any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this press release.
