**OLD NEWS WARNING: THE FOLLOWING CONTAINS OLD NEWS OLD NEWS OLD NEWS**
Peter,
thanks for your opinion on the Andrx suit as it pertains to SEPR. Also for the interesting info on Chiroscience's efforts with optically pure ketoprofen. IS that work in conjuncture with SEPR? Don't they own the international rights to the r-molecule?
Here is some more background on r-ketoprofen from 1995. Basically, as you probably recall, there was evidence of less GI irritation with the SEPR product, but Bayer decided not to develop the product. SEPR implied that Bayer did not because they feared it would compete with their own new OTC racemic ketoprufen product, Actron (wonder how that one is doing?). In the second article below, Bayer responds to that suggestion. SEPR may have been right, as Bayer acquired the rights to r-ketoprufen through their acquistion of Sterling Winthrop, and may have wanted to ditch the project from the start.
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WP BW1079 DEC 04,1995 5:51 PACIFIC 08:51 EASTERN ( BW)(SEPRACOR/BAYER)(SEPR) Bayer relinquishes OTC rights to R-ketoprofen
Business Editors
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Dec. 4, 1995--Sepracor Inc. (NASDAQ: SEPR), 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 efficacy to acetaminophen and reduced gastro-intestinal (GI) side-effects compared with racemic 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 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 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.
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CONTACT: David P. Southwell
Chief Financial Officer
Sepracor Inc.
or
Jean M. Devine
Director, Investor Relations
Sepracor Inc.
(508) 481-6700
KEYWORD: MASSACHUSETTS
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL BIOTECHNOLOGY REPEATS: New York 212-575-8822 or 800-221-2462; Boston 617-236-4266 or 800-225-2030; SF 415-986-4422 or 800-227-0845; LA 310-820-9473 BW URL: hnt.com
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WP BW1407 DEC 05,1995 16:52 PACIFIC 19:52 EASTERN ( BW)(BAYER-CONSUMER-CARE) Response to Sepracor, Inc. release: Bayer Consumer Care remains committed to Actron and ketoprofen; seeks to clarify confusion over Sepracor, Inc. release
Business Editors/Health & Medical Writers
PARSIPPANY, N.J.--(HealthWire)--Dec. 5, 1995--Bayer Consumer Care Division will introduce Actron(TM), with the newest Rx-to-OTC switch ingredient in the analgesics category, ketoprofen, in January. Bayer received clearance to market Actron as an OTC analgesic from the U.S. Food and Drug Administration (FDA) in October, 1995. Actron is an OTC pain medication indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches and backache, minor pain of arthritis, menstrual cramps and for the temporary reduction of fever.
Bayer recently decided not to pursue additional long-term clinical studies on an experimental form of ketoprofen developed by Sepracor, Inc. Actron will be introduced with the ketoprofen ingredient proven to be safe and effective in 27 countries where Bayer has marketed it as a prescription product. With more than 5 billion doses of ketoprofen prescribed worldwide, including 900 million doses in the United States since 1986, there have been relatively few reported side effects. The most common side effects are comparable to those of other prescription NSAID analgesics.
"Retailers, pharmacists and physicians all tell us that Actron with ketoprofen is the right pain reliever to offer to consumers who are looking for a new choice to help relieve their pain," said Gary S. Balkema, president, Bayer Consumer Care Division. "Our commitment to Actron remains strong."
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CONTACT: Golin/Harris Communications, Inc.
Barb Box, 312/836-7161
KEYWORD: NEW JERSEY
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL PRODUCT
REPEATS: New York 212-575-8822 or 800-221-2462; Boston 617-236-4266 or
800-225-2030; SF 415-986-4422 or 800-227-0845; LA 310-820-9473 BW URL: hnt.com |
