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8-K - CURRENT REPORT - REGENERON PHARMACEUTICALS, INC. | regeneron_8k.htm |
Exhibit 99.1
For Immediate Release
Press Release |
Regeneron Announces Settlement of Patent Litigation with Genentech for U.S. Ophthalmic Sales of EYLEA (aflibercept) Injection
Tarrytown, NY (January 3, 2012) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Company has entered into a non-exclusive license and partial settlement agreement (Agreement) with Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) relating to U.S. ophthalmic sales of EYLEA (aflibercept) Injection.
Regeneron received a non-exclusive license to certain patents relating to VEGF receptor proteins, known as the Davis-Smyth patents, and other technology patents. The Davis-Smyth patents are the subject of patent litigation between Regeneron and Genentech now pending in the United States District Court, Southern District of New York. Patent litigation is continuing with respect to matters not covered by the Agreement.
Under the terms of the Agreement, Regeneron will make payments to Genentech based on U.S. sales of EYLEA through May 7, 2016. Regeneron will pay $60 million upon cumulative U.S. sales of EYLEA reaching $400 million. Regeneron will also pay royalties of 4.75% on cumulative U.S sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative U.S sales of EYLEA over $3 billion.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated
biopharmaceutical company that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets two products, ARCALYST® (rilonacept) Injection For
Subcutaneous Use and EYLEA (aflibercept) Injection. Regeneron also has
completed several Phase 3 studies and is conducting an additional Phase 3
clinical trial for the product candidate ZALTRAP® (aflibercept)
Concentrate for Intravenous Infusion. Additional therapeutic candidates
developed from proprietary Regeneron technologies for creating fully human
monoclonal antibodies are in earlier stage development programs in rheumatoid
arthritis and other inflammatory conditions, pain, cholesterol reduction,
allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are
available on the Regeneron web site at www.regeneron.com.
Regeneron Forward-Looking Statement
This news release includes
forward-looking statements that involve risks and uncertainties relating to
future events and the future performance of Regeneron, and actual events or
results may differ materially from these forward-looking statements. These
statements concern, and these risks and uncertainties include, among others, the
nature, timing, and possible success and therapeutic applications of EYLEA and
Regenerons product candidates and research and clinical programs now underway
or planned, the likelihood and timing of possible regulatory approval and
commercial launch of Regenerons late-stage product candidates, determinations
by regulatory and administrative governmental authorities which may delay or
restrict Regenerons ability to continue to develop or commercialize EYLEA and other products and
drug candidates, competing drugs that may be superior to EYLEA and Regenerons
products and drug candidates, uncertainty of market acceptance of EYLEA and
Regenerons products and drug candidates, the possibility of EYLEA sales meeting
or exceeding any of the cumulative U.S. sales targets triggering payments to
Genentech described in this news release, unanticipated expenses, the
availability and cost of capital, the costs of developing, producing, and
selling products, the potential for any license or collaboration agreement,
including Regenerons agreements with Sanofi and Bayer HealthCare, to be
canceled or terminated without any product success, and risks associated with
third party intellectual property and pending or future litigation relating
thereto. A more complete description of these and other material risks can be
found in Regeneron's filings with the United States Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2010 and
Form 10-Q for the quarter ended September 30, 2011. Regeneron does not undertake
any obligation to update publicly any forward-looking statement, whether as a
result of new information, future events, or otherwise, unless required by law.
Contact Information:
Michael Aberman, M.D. | Peter Dworkin |
Investor Relations | Corporate Communications |
914.847.7799 | 914.847.7640 |
michael.aberman@regeneron.com | peter.dworkin@regeneron.com |