Exelixis, Inc. Announces Settlement of CABOMETYX® (cabozantinib) Patent Litigation with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc.
23 Julho 2023 - 5:00PM
Business Wire
Exelixis, Inc. (Nasdaq: EXEL) today announced that it has
entered into a Settlement and License Agreement (Agreement) with
Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals
USA, Inc. (collectively Teva). This settlement resolves patent
litigation brought by Exelixis in response to Teva’s Abbreviated
New Drug Application (ANDA) seeking approval to market a generic
version of CABOMETYX® (cabozantinib) tablets prior to the
expiration of the applicable patents.
Pursuant to the terms of the Agreement, Exelixis will grant Teva
a license to market its generic version of CABOMETYX in the United
States beginning on January 1, 2031, if approved by the U.S. Food
and Drug Administration and subject to conditions and exceptions
common to agreements of this type.
Additionally, in accordance with the Agreement, the parties will
terminate all ongoing Hatch-Waxman litigation between Exelixis and
Teva regarding CABOMETYX patents pending in the U.S. District Court
for the District of Delaware.
The Agreement is confidential and subject to review by the U.S.
Federal Trade Commission and the U.S. Department of Justice.
About Exelixis
Exelixis is a globally ambitious oncology company innovating
next-generation medicines and regimens at the forefront of cancer
care. Powered by bi-coastal centers of discovery and development
excellence, we are rapidly evolving our product portfolio to target
an expanding range of tumor types and indications with our
clinically differentiated pipeline of small molecules,
antibody-drug conjugates and other biotherapeutics. This
comprehensive approach harnesses decades of robust investment in
our science and partnerships to advance our investigational
programs and extend the impact of our flagship commercial product,
CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific
pursuit to create transformational treatments that give more
patients hope for the future. For information about the company and
its mission to help cancer patients recover stronger and live
longer, visit www.exelixis.com, follow @ExelixisInc on Twitter,
like Exelixis, Inc. on Facebook and follow Exelixis on
LinkedIn.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to Exelixis’
obligations under the Agreement, including Exelixis’ granting of a
license to Teva to market its generic version of CABOMETYX in the
United States beginning on January 1, 2031 and termination by the
parties of all ongoing Hatch-Waxman litigation regarding CABOMETYX.
Any statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements and are based upon Exelixis’ current
plans, assumptions, beliefs, expectations, estimates and
projections. Forward-looking statements involve risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements
as a result of these risks and uncertainties, which include,
without limitation: Exelixis’ ability to effect its obligations
under the Agreement; and other factors affecting Exelixis discussed
under the caption “Risk Factors” in Exelixis’ Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 9, 2023 and Annual Report on Form 10-K filed with the SEC on
February 7, 2023, and in Exelixis’ future filings with the SEC. All
forward-looking statements in this press release are based on
information available to Exelixis as of the date of this press
release, and Exelixis undertakes no obligation to update or revise
any forward-looking statements contained herein, except as required
by law.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks.
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version on businesswire.com: https://www.businesswire.com/news/home/20230721235791/en/
Investors Contact: Susan Hubbard EVP, Public Affairs and
Investor Relations Exelixis, Inc. (650) 837-8194
shubbard@exelixis.com
Media Contact: Claire McConnaughey Senior Director,
Public Affairs Exelixis, Inc. (650) 837-7052
cmcconn@exelixis.com
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