Sepracor awarded patent for R-ondasentron, its eleventh U.S. patent for an improved form of an FDA-approved drug; Patent reinforces Sepracor's proprietary position in pharmaceutical marketplace.
Marketed by Glaxo Wellcome as Zofran, racemic ondansetron is a leading antiemetic used to treat nausea and vomiting associated with chemotherapy treatments and surgery. Sepracor estimates that emesis occurs in 70 percent of the 3.6 million chemotherapy episodes and 30 percent of the 23 million surgical procedures performed in the U.S. each year. The sales of Zofran in 1994 were approximately $600 million.
Despite its effectiveness for emesis, racemic ondansetron has shown a meaningful incidence of adverse side effects such as tachycardia, angina and electrocardiographic alterations, including second-degree heart block which is most prevalent in nonchemotherapy uses. Sepracor believes that the single isomer of ondansetron provides an opportunity for development of a safer, more effective antiemetic.
"This patent reinforces our proprietary position in the pharmaceutical marketplace and furthers our strategy to develop safer, purer and more effective versions of already popular and proven therapeutics," said Timothy J. Barberich, Sepracor's President and Chief Executive Officer. "R-ondansetron shows the potential to become an effective antiemetic with a significantly improved cardiovascular side-effect profile over racemic ondansetron."
Sepracor's preclinical trials have indicated that R-ondansetron has superior antiemetic activity compared with the racemic product, while S-ondansetron causes cardiovascular side effects.
Sepracor develops Improved Chemical Entities (ICE) that are enhanced forms of existing, widely sold pharmaceuticals. ICEs can be developed at significantly less cost, time and risk than New Chemical Entities (NCEs), thus providing a pipeline of new product opportunities with significant market potential. -0-
Zofran is a registered trademark of Glaxo Wellcome plc.
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