IL-1 Trap Phase 3 Trial Data Presented at Annual Meeting of American Academy of Allergy, Asthma and Immunology (AAAAI)

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Feb 27, 2007 - Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that efficacy and safety data for the Phase 3 clinical trial of Regeneron's Interleukin-1 (IL-1) Trap (rilonacept) in patients with Cryopyrin-Associated Periodic Syndromes (CAPS) were presented at the 2007 American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in San Diego, CA. The presentation was made by Dr. Hal Hoffman, Associate Professor of Pediatrics and Medicine, Division of Rheumatology, Allergy, and Immunology at the University of California at San Diego. This is the first presentation of the data at a scientific conference, having been accepted as a late-breaking abstract for the annual meeting.

"Placebo-controlled studies such as this study are a necessary step in the process of seeking approval to make this drug candidate available to this group of patients with an unmet clinical need," said Dr. Hoffman. "The IL-1 Trap therapy resulted in improvement in quality of life and a significant reduction in the number of days these patients experienced symptoms."

In October 2006, Regeneron announced positive data from this Phase 3 clinical program. The trial was designed to provide two separate demonstrations of efficacy for the IL-1 Trap, a long-acting IL-1 inhibitor, in adult patients suffering from Familial Cold Autoinflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS). The IL-1 Trap has not yet been evaluated in patients with Neonatal Onset Multisystem Inflammatory Disorder (NOMID). The trial included two studies (Part A and Part B). Both studies met their primary endpoints (Part A: p less than 0.0001 and Part B: p = 0.0002). The primary endpoint of both studies was the change in disease activity, which was measured using a composite symptom score composed of a daily evaluation of fever/chills, rash, fatigue, joint pain, and eye redness/pain. This double-blind, placebo-controlled study of the IL-1 Trap in 47 patients with CAPS demonstrated rapid, substantial and lasting reduction of clinical signs and symptoms, as well as laboratory measures of inflammation in patients. A favorable safety and tolerability profile was also observed.

Regeneron plans to submit a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the second quarter of 2007, following completion of a 24-week open-label extension phase. The FDA has granted Orphan Drug status and Fast Track designation to the IL-1 Trap for the treatment of CAPS.

The presentation took place on Tuesday, February 27 at 2:00 p.m. Pacific Time. The presentation slides may be accessed through the Company's website (www.Regeneron.com on the Events page, under the Investor Relations heading).

About Regeneron Pharmaceuticals

Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders.

This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of our drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize our drug candidates, competing drugs that are superior to our product candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including our agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. 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 (SEC), including its Form 10-K for the year ended December 31, 2005 and Form 10-Q for the quarter ended September 30, 2006. 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.

Additional information about Regeneron and recent news releases are available on Regeneron's worldwide web site at www.regeneron.com.

Contact

Regeneron
Charles Poole
Vice President, Investor Relations
914-345-7640
charles.poole@regeneron.com
or
For Regeneron
Lauren Tortorete
Media Relations
212-845-5609
ltortorete@biosector2.com

Posted: February 2007

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