CORONA, Calif., April 24 - Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical
company, today confirmed that its subsidiary Watson Laboratories, Inc. (a
Nevada Corporation) has filed an Abbreviated New Drug Application (ANDA)
with the U.S. Food and Drug Administration (FDA) seeking approval to market
its Fentanyl Buccal Tablets C-II product prior to the expiration of patents
owned by Cephalon, Inc. Watson’s Fentanyl Buccal Tablets C-II product is a
generic version of Cephalon’s FENTORA(R) C-II (fentanyl buccal tablet)
which is indicated only for the treatment of breakthrough pain in opioid
tolerant patients with cancer.
In its Notice Letter to Cephalon, Watson contends that U.S. Patent
Numbers 6,200,604 and 6,974,590 are invalid, unenforceable and/or will not
be infringed by Watson’s manufacture, use or sale of the product described
in its ANDA. Based on available information, Watson believes it may be the
first applicant to file an ANDA for FENTORA(R) containing a paragraph IV
certification under the provisions of the Hatch-Waxman Act and, should its
product be approved, may be entitled to 180 days of generic market
exclusivity.
Forward-Looking Statement
Any statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements that
reflect Watson’s current perspective of existing trends and information as
of the date of this release. Except as expressly required by law, Watson
disclaims any intent or obligation to update these forward-looking
statements. Actual results may differ materially from Watson’s current
expectations depending upon a number of factors affecting Watson’s
business. These factors include, among others, patents and other
intellectual property rights held by competitors and other third parties
and the uncertainty of the outcome of litigation related to such patents
and intellectual property rights; the difficulty of predicting the timing
or outcome of product development efforts and FDA or other regulatory
agency approvals or actions; the impact of competitive products and
pricing; market acceptance of and continued demand for Watson’s products;
difficulties or delays in manufacturing; and other risks and uncertainties
detailed in Watson’s periodic public filings with the Securities and
Exchange Commission, including but not limited to Watson’s Annual Report on
Form 10-K for the year ended December 31, 2007.
FENTORA(R) is a registered trademark of Cima Labs, Inc., a subsidiary
of Cephalon, Inc.
SOURCE Watson Pharmaceuticals, Inc.