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

To: RCMac who wrote (2786)	5/17/1999 6:57:00 AM
From: BMcV	Respond to of 10280

Website news release isn't news, but might clarify a few issues (funding, development timetable). >>J&J ELECTS NOT TO EXERCISE OPTION TO CO-PROMOTE NORASTEMIZOLE Sepracor to complete development and market product MARLBOROUGH, Mass., May 14, 1999 - Sepracor Inc. (Nasdaq: SEPR) today announced that Johnson & Johnson (NYSE: JNJ) has elected not to exercise its option to co-promote norastemizole. Sepracor will continue to fund clinical development and marketing of the drug, which is currently in Phase III clinical trials. Norastemizole is a third generation nonsedating antihistamine being developed for seasonal and perennial allergic rhinitis. Under the terms of the agreement between Sepracor and Johnson and Johnson, Sepracor has worldwide rights to all Johnson & Johnson intellectual property covering norastemizole, including the right to reference data from the astemizole New Drug Application (NDA), for Sepracor's norastemizole NDA filing. In exchange, Johnson & Johnson will receive a royalty on Sepracor's product sales. "Johnson & Johnson had a choice to co-promote or to receive royalty payments on Sepracor's sales. It is our understanding that based on their economic analysis, they chose to receive royalties," said Timothy J. Barberich, President and Chief Executive Officer. "We look forward to norastemizole complementing our growing respiratory portfolio, which includes XopenexTM inhalation solution and (R,R)-formoterol." "In conjunction with other prelaunch activities the Company expects to present its scientific data concerning norastemizole at upcoming scientific conferences," said Paul D. Rubin, Executive Vice President, Drug Development and ICE Research. "Our development program is on track for NDA submission by the end of 2000." To view information on norastemizole clinical trials, please Click Here. Sepracor's partnership with Johnson & Johnson on (+)-norcisapride remains unchanged.<<

To: RCMac who wrote (2786)	5/17/1999 7:04:00 AM
From: BMcV	Read Replies (1) \| Respond to of 10280

Nori trial date link: sepracor.com Here's a summary: >> More than 3,300 patients with perennial and/or seasonal allergic rhinitis have received norastemizole in clinical trials Norastemizole at a dose of 30 mg demonstrates an effect on symptoms of allergic rhinitis within 20 minutes after dosing Norastemizole at a dose of 30 mg reduces symptoms for up to 24 hours in subjects with seasonal allergic rhinitis Norastemizole at 30 mg was well-tolerated, with no reports of weight gain in clinical studies and no obvious sedation << Due to formatting reasons, I can't publish more here, but at first blush results look very good to me, much better than I expected. Nori is 30 times more potent at binding H1 receptors than loratadine, and ten times better than the parent compound, astemizole. Side effects look about comparable with placebo, and onset of activity is about 20 minutes, which has been a big problem with Hismanal. Activity lasts 24 hours. J&J simply made a business decision, not a judgement on this drug.