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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: BMcV who wrote (1405)	11/10/1998 8:51:00 AM
From: Ed Ajootian	Read Replies (1) \| Respond to of 10280

Bruce, As I've learned long ago, when it comes to publicly held companies, good news travels fast and bad news travels even faster. Something tells me the folks shelling out $75 to acquire shares in this puppy know something definitive that we don't.

To: BMcV who wrote (1405)	11/11/1998 8:42:00 AM
From: Ed Ajootian	Read Replies (1) \| Respond to of 10280

Sepracor Announces Phase II Results of (S)-Oxybutynin Proof-of-Concept Trial; Study Designed to Show Efficacy and Tolerability in Patients PR Newswire - November 11, 1998 07:14 MARLBOROUGH, Mass., Nov. 11 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR) today announced the results of a Phase II, 186 patient (S)-oxybutynin study. This two-week, double-blind, randomized, placebo-controlled, pilot trial was designed to evaluate the efficacy of two doses of (S)-oxybutynin in the treatment of symptoms associated with urge urinary incontinence. This study was powered to demonstrate the ability of (S)-oxybutynin to reduce urinary frequency while rigorously monitoring for potential anticholinergic side effects, such as dry mouth. In addition, episodes of involuntary urination (incontinence) were also monitored. (S)-oxybutynin significantly reduced urinary frequency in a dose-dependent manner by 1.9 to 2.8 episodes per day (p= .001). This improvement was as high as 18 percent greater than that seen with placebo. In addition, mean incontinence episodes were reduced up to 1.3 per day. This change was up to 42 percent greater than baseline (p< .001) and 33 percent greater than placebo (p= .003 at week one and p= .053 at week two). In addition, 50-52 percent of treated patients exhibited 50 percent or greater improvement in urinary incontinence at study end versus 31 percent of the placebo treated patients (p= .034). Finally, 29 percent of the high dose treated subjects achieved full continence versus 14 percent of the placebo treated subjects (p= .057). (S)-oxybutynin was well tolerated with only 14-16 percent of patients experiencing moderate-severe dry mouth. "Without any attempt at dose optimization, this study clearly shows that (S)-oxybutynin reduced both urinary frequency and incontinence episodes while demonstrating good tolerability," said Dr. Paul D. Rubin, Senior Vice President, Drug Development. "The results of this trial appear to validate preclinical observations that (S)-oxybutynin imparts a spasmolytic effect independent of its anticholinergic properties." Urinary incontinence affects approximately 13 million people in the United States. An estimated 5 to 8 million Americans suffer from urge urinary incontinence. Drug therapy to treat urinary incontinence has been limited in its use due to the side effects of existing drugs. As a result, a majority of the patients for both urge and stress incontinence rely on diapers or incontinence devices. Worldwide sales of these alternatives were approximately $2 billion in 1997. "The urinary incontinence market represents a large and growing population which has traditionally been underserved by pharmaceutical products," said Timothy J. Barberich, Sepracor's President and CEO. "Moving (S)-oxybutynin through the required clinical trials is a high priority for Sepracor. We are also developing the (+) metabolite of sibutramine, a serotonin reuptake inhibitor and noradrenaline reuptake inhibitor for stress incontinence, and (S)-doxazosin for the treatment of benign prostatic hyperplasia (BPH). Combined, these three programs will provide a platform for Sepracor's entry into the urology market." Data from this Phase II trial have been submitted in abstract form to be presented at the American Urological Association meeting in Spring of 1999. 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(TM) 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 timing of filing and approval of NDAs, 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. To receive a copy of this release or recent releases via fax, call Sepracor's automated new fax line at 1-800-758-5804 ext. 780960. SOURCE Sepracor Inc. /CONTACT: David P. Southwell, Chief Financial Officer, or Jonae R. Barnes, Executive Director, Investor Relations, both of Sepracor, 508-481-6700/ ************************************************************************ Had it all the way! When are you guys gonna start taking The Kid seriously? <g>