Regeneron Announces ZALTRAP® Clinical Presentation at European Multidisciplinary Cancer Congress

Sep 23, 2011, 07:00 ET from Regeneron Pharmaceuticals, Inc.

TARRYTOWN, N.Y., Sept. 23, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that additional data from the Phase 3 VELOUR trial will be presented at the 2011 European Multidisciplinary Cancer Congress (EMCC) which will take place from September 23-27 in Stockholm, Sweden.  

The data will be presented as a late breaker, by Prof. Josep Tabernero, on Sunday, September 25, at 6:40 AM EDT.  Prof. Tabernero is Head of Medical Oncology at Vall d'Hebron University Hospital, Spain, and one of the lead investigators in the VELOUR trial. The title of his presentation is "Results from VELOUR, a Phase 3 Study of Aflibercept Versus Placebo in Combination with FOLFIRI for the Treatment of Patients with Previously Treated Metastatic Colorectal Cancer: Results from Prespecified Subgroup Analyses."

About ZALTRAP® (aflibercept) and the Clinical Development Program

ZALTRAP, also known as aflibercept, is an investigational angiogenesis inhibitor with a unique mechanism of action.  This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. ZALTRAP has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their native receptors.

Sanofi Oncology and Regeneron are collaborating on a broad oncology development program for ZALTRAP.  The Phase 3 clinical program was designed to evaluate ZALTRAP in combination with common chemotherapy regimens in the treatment of patients with advanced cancers, including cancers where bevacizumab has not demonstrated efficacy.  Patients who had previously received bevacizumab were also included in the clinical trials for certain second-line treatment settings.  The current development program is focused on metastatic prostate and colorectal cancers and includes the following late stage trials:

  • VENICE: First-line treatment for androgen-independent (hormone-refractory) metastatic prostate cancer in combination with docetaxel and prednisone (Phase 3).  Final results are anticipated in 2012.
  • AFFIRM: First-line treatment in metastatic colorectal cancer in combination with a modified FOLFOX6 regimen (Phase 2).  Final results are expected during the second half of 2011.

About Colorectal Cancer

Worldwide, colorectal cancer is the third most commonly diagnosed cancer in males and the second most in females, with more than 1.2 million new cases diagnosed in 2008.  Colorectal cancer is one of the deadliest cancers and was responsible for more than 600,000 deaths in 2008 alone.  In Europe the overall survival rate is 43 percent, whereas in the United States it is 62 percent; these numbers drop considerably when the cancer spreads to distant organs.  The risk of colorectal cancer increases with age – in developed countries, more than 90 percent of cases are diagnosed in individuals older than age 50.

About Regeneron Pharmaceuticals

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, which is approved for the treatment of a rare inflammatory condition, Regeneron has completed Phase 3 clinical trials of rilonacept for a new indication and of product candidates EYLEA™ (aflibercept injection; VEGF Trap Eye) in diseases of the eye and ZALTRAP® (aflibercept) (VEGF Trap) in colorectal cancer.  EYLEA is currently under review with U.S. and European regulatory authorities.  Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis, pain, cholesterol reduction, allergic and immune conditions, and cancer.  Additional information about Regeneron and recent news releases are available on

Forward Looking Statements

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial 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 Regeneron's product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that may be superior to Regeneron's product and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, 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 Regeneron's 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 June 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



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