Sepracor To Develop Zopiclone For Sleep Disorders
U.S. Patent Awarded for Single Isomer of Imovane(R)
MARLBOROUGH, Mass., Aug. 5 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR) announced today it has been granted U.S. Patent No. 5,786,357 on (+) zopiclone, a single-isomer form of a drug marketed in Europe for the treatment of sleep disorders by Rhone-Poulenc Rorer sold under the brand name of Imovane(R). The patent covers methods and compositions for treating sleep disorders using (+) zopiclone.
Sleep disorders affect 56 million people in the United States. If successfully developed, this drug will represent the second non-benzodiazepine treatment for sleeping disorders in the U.S. Currently, the market is served primarily by zolpidem tartrate, marketed as Ambien(R) by Searle. In 1997, U.S. sales for Ambien were approximately $500 million.
Zopiclone, a short-acting hypnotic agent, is structurally unrelated to traditional benzodiazepine hypnotic therapies for sleeping disorders. Sepracor has shown in preclinical studies that the activity responsible for efficacy predominantly resides in the (+) isomer of zopiclone.
Zopiclone, available only outside the U.S., reduced sleep latency, increased the duration of sleep, and decreased the number of nocturnal awakenings in sleep studies conducted in man. Studies have shown loss of beneficial sleep-inducing effect may occur during treatment with benzodiazepines, such as Halcion(R). In two separate trials, zopiclone maintained its ability to induce sleep for the duration of the trials, which was in excess of four weeks. Rhone-Poulenc Rorer's U.S. patents covering zopiclone expired in 1994.
"Sepracor has initiated preclinical studies in support of an IND which the company plans to submit in the first quarter of 1999. Given that the (+) isomer is predominately responsible for the activity of the drug, we expect that (+) zopliclone will have equivalent efficacy while potentially showing improvements in the side effect profile," said Dr. Paul D. Rubin, Senior Vice President of Drug Development at Sepracor.
"This adds to our growing portfolio of drug candidates to treat central nervous system disorders," said Timothy J. Barberich, Sepracor's President and Chief Executive Officer. "Other Sepracor drug candidates in this category include (R)-fluoxetine, a single-isomer form of the drug marketed as Prozac(R) under development for the treatment of depression, (S)-fluoxetine for the prophylactic treatment of migraine headaches, (R)-bupropion for smoking cessation, and (S)-sibutramine, a single-isomer form of Meridia(R), for the treatment of obesity."
Sepracor is a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely-prescribed drugs. Referred to as Improved Chemical Entities ("ICE"), Sepracor's ICE Pharmaceuticals are being developed as proprietary, single-isomer or active- metabolite versions of these leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases the opportunity for additional indications.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of the company's ICE Pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of the company's clinical trials with respect to its products under development; the scope of the company's patent protection with respect to such product candidates; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the company's periodic reports filed with the Securities and Exchange Commission.
Ambien is a registered trademark of Synthelabo. Imovane is a registered trademark of Rhone-Poulenc Sante. Meridia is a registered trademark of Knoll Pharmaceutical Company. Prozac is a registered trademark of Eli Lilly and Company. Halcion is a registered trademark of Pharmacia & Upjohn.
To receive a copy of this release or any recent release via fax, call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960.
SOURCE Sepracor Inc.
CO: Sepracor Inc.
ST: Massachusetts
IN: MTC
SU: PDT
08/05/98 15:17 EDT prnewswire.com |
