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Bayer relinquishes OTC rights to R-ketoprofen.


MARLBOROUGH, Mass.--(BUSINESS WIRE)--Dec. 4, 1995--Sepracor 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
: SEPR SEPR Senior Enlisted Performance Report ), today announced that Bayer Corporation's Consumer Care Division, which is responsible for its over-the-counter products, has decided not to proceed with the over-the-counter R-ketoprofen project. Sepracor will continue to pursue opportunities in the prescription market.

This action followed the completion of several clinical trials involving more than 250 patients, which demonstrated comparable analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  efficacy to acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol.  and reduced gastro-intestinal (GI) side-effects compared with racemic racemic /ra·ce·mic/ (ra-se´mik) optically inactive, being composed of equal amounts of dextrorotatory and levorotatory isomers.

ra·ce·mic
adj. Abbr.
 ketoprofen. Specifically, the study reported the following, as outlined by Bayer in a study report to Sepracor:

Efficacy Study, using the dental pain model comparing single doses of 25mg and 100mg R-ketoprofen, 1000mg acetaminophen, and placebo. R-ketoprofen 25mg did not separate from placebo, while both R-ketoprofen 100mg and acetaminophen 1000mg showed evidence of analgesic efficacy when compared with placebo. GI Endoscopic en·do·scope  
n.
An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach.



en
 Study, comparing R-ketoprofen 100mg, racemic ketoprofen 100mg, acetaminophen 1000mg, and placebo in twice a day over 2 1/2 days. Results showed R-ketoprofen induced significantly fewer lesions than racemic ketoprofen, indicating a relatively safer gastro-intestinal profile. However, acetaminophen and placebo, which were not significantly different from one another, showed fewer gastrointestinal side-effects than either of the ketoprofens.

"While we realize that this product does not fit Bayer's OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 strategy, in view of the results of this efficacy study, Sepracor intends to pursue opportunities for R-ketoprofen as a prescription pain drug." said Timothy J. Barberich, President and Chief Executive Officer.

Sepracor licensed OTC R-ketoprofen in late 1992 to Sterling Winthrop Inc.'s OTC division, a leading global marketer of over-the-counter acetaminophen. Sepracor retained worldwide Rx rights to the product and was issued a US patent in July 1994. Sterling's OTC business was subsequently sold to SmithKline Beecham and Bayer in late 1994. Bayer's Consumer Care Division recently announced marketing clearance for Actron., racemic ketoprofen, as an OTC product.

Sepracor develops Improved Chemical Entities (ICEs ), which are improved versions of existing, widely-sold drugs. -0-

Actron is a registered trademark of Bayer Corporation.

CONTACT: David P. Southwell

Chief Financial Officer

Sepracor Inc.

or

Jean M. Devine

Director, Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 

Sepracor Inc.

(508) 481-6700
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 4, 1995
Words:345
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