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FDA Licenses Regeneron Manufacturing Facility.


TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec. 9, 1999--

Regeneron Begins Commercial Manufacture Of

Vaccine Intermediate For Merck

Regeneron Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: REGN) announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 has approved Regeneron as a contract manufacturer of an intermediate for an existing Merck & Co., Inc. (NYSE NYSE

See: New York Stock Exchange
: MRK) pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 vaccine. Regeneron manufactures the intermediate at its Rensselaer, New York Rensselaer is a city in Rensselaer County, New York, U.S., located on the Hudson River, directly opposite Albany. As of the 2000 census, the city population was 7,761; in 1920, it was 10,832.  facility under an FDA-approved supplement to Merck's Establishment License Application.

Commercial production of the intermediate under Regeneron's long-term manufacturing agreement with Merck will extend over the next six years. Payments from Merck will depend on the volume of intermediate supplied each year. At the minimum quantities in the agreement, total payments over the six years are expected to be in excess of $50 million.

Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, commented, "Regeneron's production of pharmaceutical material under the FDA's current Good Manufacturing Practices moves us closer to fulfilling our long-term objective of becoming a fully integrated pharmaceutical company. The Merck agreement permits us to fully utilize our production capacity and our experience and expertise in manufacturing pharmaceutical products. It also provides revenue that helps fund our drug development programs. We are pleased to have this ongoing relationship with one of the premier firms in the pharmaceutical industry."

Regeneron also produces brain-derived neurotrophic factor Brain-derived neurotrophic factor (BDNF) is a neurotrophic factor found in the brain and the periphery. It is a protein that acts on certain neurons of the central nervous system and the peripheral nervous system that helps to support the survival of existing neurons and encourage  (BDNF) at its Rensselaer facility for use by Sumitomo Pharmaceuticals Company, Ltd. in clinical trials in Japan. Regeneron and Sumitomo are jointly developing BDNF for the treatment in Japan of amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, , commonly known as Lou Gehrig's disease Lou Geh·rig's disease
n.
See amyotrophic lateral sclerosis.
.

Regeneron is a leader in the application of molecular and cell biology to the search for novel human therapeutics. Regeneron uses its expertise in growth factors and their mechanisms of action to discover and develop protein-based and small molecule drugs. Regeneron is currently conducting a clinical program for AXOKINE second generation ciliary neurotrophic factor for the treatment of obesity and complications of obesity such as Type II diabetes Type II diabetes
Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise.

Mentioned in: Diabetic Ketoacidosis
. Regeneron is also conducting clinical trials, in partnership with Amgen Inc., of brain-derived neurotrophic factor for the treatment of amyotrophic lateral sclerosis and of neurotrophin-3 for the treatment of constipation associated with spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
 and other medical conditions. The Company has a number of research collaborations, including a broad-based, long-term agreement with The Procter & Gamble Company.

This news release discusses historical information and includes forward looking statements about Regeneron's 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, 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 factors that may affect future operating results can be found in Regeneron's Form 10-K for the year ended December 31, 1998 and current Form 10-Q, copies of which should be read before making any investment decision regarding Regeneron common stock.

Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regeneron.com. Fax copies of news releases can be obtained from Regeneron's News-on-Demand Service by dialing (800) 311-0841.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 9, 1999
Words:552
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