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VEGF Trap Oncology Program with Sanofi-Aventis Planned to Expand Rapidly; Regeneron Updates Clinical Programs and Financial Guidance.


TARRYTOWN, N.Y. -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today described plans with the sanofi-aventis Group to expand the VEGF VEGF vascular endothelial growth factor.  Trap oncology program and provided an update of its development pipeline and financial guidance. Leonard S. Schleifer, M.D., Ph.D., chief executive officer and president of Regeneron, will discuss the Company's plans at the UBS UBS Union Bank of Switzerland
UBS United Bible Societies
UBS United Blood Services
UBS United Buying Service
UBS Used Bookstore
UBS University Business Services
UBS Universal Building Society (UK)
UBS Ulaanbaatar Broadcasting System
 Global Life Sciences Conference on Tuesday, September 27 at 12:00 PM (EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
). The presentation will be webcast live in the investor relations Investor relations

The process by which the corporation communicates with its investors.
 section of the Company's website (www.regeneron.com) and be available at that link through October 26, 2005.

VEGF Trap Program in Oncology

Regeneron and sanofi-aventis, who are collaborating in the development and commercialization of the Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature).  (VEGF) Trap in oncology, are expanding the VEGF Trap development program. The companies plan to initiate up to six new efficacy/safety trials, and up to ten additional trials may be conducted through the National Cancer Institute (NCI See Liberate. ) under a Clinical Trials Agreement between the Cancer Therapeutics Evaluation Program (CTEP CTEP Cancer Therapy Evaluation Program
CTEP Community Transportation Enhancement Program (Montana)
CTEP Chartered Trust and Estate Planner
CTEP Community Technology Empowerment Project
CTEP Collaborative Teacher Education Program
), NCI, and sanofi-aventis.

Three of the efficacy/safety studies are designed as single-agent trials that will be conducted in a variety of indications, including one that has already received fast track designation from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). These studies are planned to begin in the fourth quarter of 2005 and the first quarter of 2006.

Three other efficacy/safety studies will evaluate the VEGF Trap in combination with standard chemotherapy regimens in patients with different cancer types. Two of these studies could begin as early as the second half of 2006, following successful completion of initial combination safety and tolerability studies. Two safety and tolerability combination studies are ongoing, and three more are scheduled to begin as early as the fourth quarter of 2005.

In addition, CTEP plans to sponsor up to ten exploratory efficacy/safety studies evaluating the VEGF Trap in a variety of cancer types. These trials are planned to start in 2006.

VEGF Trap Program in Eye Disease

Regeneron is developing the VEGF Trap for the treatment of the neovascular form of age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 (wet AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ) utilizing intravitreal (or direct) injection into the eye. A Phase 1 dose-escalating study to assess the safety and tolerability of the VEGF Trap commenced in June 2005. Regeneron could initiate a Phase 2 trial in this indication as early as late 2005 or early 2006. Preclinical data, clinical trial results from the Company's intravenous (systemic delivery) VEGF Trap Phase 1 trial in wet AMD, and clinical results from other molecules that target VEGF provide a strong rationale for this program. There are approximately 1.6 million people in the United States who are affected by wet AMD.

IL-1 Trap Development Program

Regeneron's Interleukin (IL-1) Trap program is directed towards diseases where IL-1 may play an important role. In the fourth quarter of 2004, the Company initiated a pilot study of the IL-1 Trap in patients with CIAS CIAS Center for Integrated Agricultural Systems (UW-Madison)
CIAS Changi International Airport Services (Singapore)
CIAS Canadian International Air Show
CIAS Canadian International Auto Show
1-associated periodic syndrome (CAPS), a spectrum of rare genetic diseases. Preliminary clinical data from this study have been encouraging. Regeneron is currently in discussions with the FDA to finalize the design of a pivotal registration study, which is planned to begin in the fourth quarter of 2005.

In the fourth quarter of 2005, Regeneron plans to initiate a pilot study in systemic onset juvenile idiopathic arthritis
This article does not deal with the more general topic of childhood arthritis.


Juvenile idiopathic arthritis (JIA), formerly known as juvenile rheumatoid arthritis (JRA),[1]
 (SoJIA), a disease in which IL-1 is believed to play an important role. It is estimated that between 5,000-10,000 children in the United States suffer from SoJIA, which continues to be a disease with a major unmet medical need.

The Company has also initiated pilot studies in osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
 (OA) and polymyalgia rheumatica Polymyalgia Rheumatica Definition

Polymyalgia rheumatica is a syndrome that causes pain and stiffness in the hips and shoulders of people over the age of 50.
 (PMR PMR 1 Percutaneous myocardial revascularization, see there 2 Perinatal mortality rate 3 Polymyalgia rheumatica 4 Proportionate mortality ratio, see there ). In addition, at the American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
 Scientific Sessions meeting in November 2005, the Company will report positive preliminary data from a pilot study indicating that the IL-1 Trap provided prolonged suppression of C-reactive Protein (CRP C-reactive protein (CRP)
A protein present in blood serum in various abnormal states, like inflammation.

Mentioned in: Pelvic Inflammatory Disease

CRP,
n.pr See C-reactive protein.
), a marker of inflammation, in otherwise healthy adults.

Regeneron has discontinued development of the IL-1 Trap in adult rheumatoid arthritis. The increasing number of treatments approved or in development for adult rheumatoid arthritis makes development and commercialization of new treatments for this disease extremely challenging.

Updated Financial Guidance

Regeneron expects to end 2005 with $285 - $295 million of cash and marketable securities and believes that, based on current plans, it has sufficient funds to operate through mid-2008. Sanofi-aventis funds 100 percent of VEGF Trap oncology development costs, of which 50 percent are repayable to sanofi-aventis following commercialization of the VEGF Trap. Regeneron currently funds the VEGF Trap eye program, and will seek to partner this program prior to initiating Phase 3 development.

Regeneron plans to reduce its workforce from the current level of 730 to approximately 565. The reductions result principally from narrowing the focus of the Company's research and development efforts, substantial improvements in manufacturing productivity, and the expected completion of contract manufacturing for Merck & Co., Inc. in late 2006. The majority of this reduction will occur by the end of 2005 with the remainder in 2006 following the completion of contract manufacturing.

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 in clinical trials 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 drugs and biologics, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be canceled or to terminate without any product success, and other material risks. A more complete description of these 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, 2004 and the Form 10-Q dated June 30, 2005. 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
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 26, 2005
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