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| |  R-albuterol Asthma Trial for Children Under the Age of 12 MARLBOROUGH, Mass. -- Oct. 28, 1996 -- First R-albuterol study especially designed for asthmatic children under the age of 12. Sepracor Inc. (Nasdaq: SEPR) announced today that it has initiated a pediatric clinical trial on R-albuterol, the single-isomer form of albuterol. This trial, involving children from 2 to 11 years old, is designed to demonstrate R-albuterol as a safe and effective alternative to the widely prescribed bronchodilator, racemic albuterol (Ventolin and Proventil), which most children take in either nebulized solution or syrup form. Sepracor's clinical study, using an inhalation solution (nebulized) of R-albuterol and racemic albuterol, is designed to replicate the findings of Sepracor's previously reported Phase II adult study. This study showed that R-albuterol, compared with racemic albuterol, exhibited equal improvements in the lung function of asthmatics, with less incidence of cardiac side effects and tremor. Side effects occur in 20 percent of patients taking nebulized racemic albuterol, and in a higher percentage of patients taking oral racemic albuterol, as referenced in the package insert. "The medical community is strongly supportive of studies which clearly establish the appropriate dose and dosing frequency for asthmatic children," said Timothy J. Barberich, Sepracor's President and CEO. "This is an important study as children represent approximately forty percent of the 100 million asthmatics worldwide, and the prevalence of asthma is on the rise, especially among children." "Most children take albuterol in nebulizer form because they cannot use the more complicated metered dose inhaler (MDI). However, it is widely understood that nebulizer users receive higher levels of systemic exposure, which leads to such side effects as tachycardia, tremor and insomnia," added Dr. Paul D. Rubin, Senior Vice President of Sepracor's Pharmaceutical Development. "Sepracor is focused on reducing the occurrence of such events, which limit the use of the parent drug." Sepracor's pediatric trial is being conducted at two U.S. asthma treatment centers. The results from this study will be included in Sepracor's New Drug Application (NDA) for nebulized R-albuterol. "Pediatricians desire an asthma medication that promotes breathing with fewer side effects," said Dr. Michael J. Noonan of Portland, Oregon. "This study and subsequent trials should produce findings useful for labeling and for guidelines for treating asthmatic children." "The importance of reduced cardiovascular and tremor side effects has been confirmed through independent focus groups with pediatricians, pulmonologists and allergists. Both doctors and parents clearly desire the safest bronchodilator possible and dosing regimen tailored specifically for children," said David S. Barlow, President, Sepracor Pharmaceuticals. "We have received resounding support for our commitment to achieving these objectives, and look forward to reporting the results from this and other important pediatric and adult clinical studies." Sepracor also is conducting a Phase III R-albuterol trial involving 300 adult asthmatics and will complete patient enrollment by the end of 1996. The company expects to file an NDA for nebulized R-albuterol before mid-1997. In addition, Sepracor is developing R-albuterol for its proprietary breath-actuated metered-dose inhaler (MDI) and dry-powder inhaler (DPI) systems, and for syrup and tablet formulations. Sepracor is building a specialty sales force to market R-albuterol and other upper respiratory treatments in its portfolio, including a differentiated long-acting bronchodilator, and third-generation antihistamines. Sepracor's first upper respiratory product, terfenadine carboxylate, also know as fexofenadine and marketed as Allegra, recently received marketing clearance from the FDA. Sepracor licensed its U.S. patent rights for this improved form of Seldane to Hoechst Marion Roussel (HMR), who in turn developed and launched the compound in under three years. Sepracor also is developing Norastemizole, an active metabolite of astemizole, which is marketed by J & J as Hismanal. With Allegra, Norastemizole becomes the second opportunity to make meaningful improvement to a non-sedating antihistamine through Sepracor's Improved Chemical Entity (ICE) strategy. Sepracor develops Improved Chemical Entities (ICEs), which are improved versions of existing, widely-sold drugs. Ventolin and Proventil are registered trademarks of Glaxo Wellcome plc and Schering-Plough Corp., respectively. Seldane is a registered trademark of Merrell Dow Pharmaceuticals, Inc. and Allegra is a trademark of Hoechst Marion Roussel (HMR). Hismanal is a registered trademark of Janssen Pharmaceutica N.V.
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