Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
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Paris Course on Revascularization (EuroPCR)
Summary: European use of drug-eluting stents is growing about 1% a month, and Boston Scientific's Taxus has captured nearly 40% of the market with pricing about 20% below Johnson & Johnson's Cypher. Taxus is expected to capture most of the U.S. market if the restenosis rate is equal to or lower than for Cypher. Serious questions about the safety of Taxus were raised: (1) >90% of the drug remains on the stent past 180 days, and (2) peri-stent vessel thickening was observed by IVUS in TAXUS-2 at 12 months. A new issue also has come up with Cypher - focal lesions, which may be related to the rather stiff stent design.
The FDA View of Non-Inferiority Trials - Quick Pulse
Summary: A number of drugs are in development for which the manufacturer (sponsor) hopes to use one or more non-inferiority trials for FDA approval. The fate of these drugs may hinge on the Agency's view of non-inferiority trials. Two senior FDA officials and other experts agreed to discuss the questions and issues surrounding non-inferiority trials.
Association for Research in Vision and Ophthalmology (ARVO)
Summary: For AMD: Bristol-Myers Squibb's Kenalog is getting more and more attention. Doctors predicted EyeTech's EYE001 is the one to watch, but there was no new data on this. Genentech's anti-VEGF, Lucentis, got a lukewarm reception. The Phase III trial of Alcon's anecortave is enrolling slowly, but the dropout rate is low. Meanwhile QLT acts like these Visudyne competitors don't exist. For uveitis: Hopes are fading for B&L's Retisert back-of-the-eye implant. For dry eye: Allergan's Restasis is off to a strong start, but Alcon has 15(S)-HETE in development. For glaucoma: The marketing wars continue.
American Urologic Association
Summary: U.S. urologists view Viagra, Cialis and Levitra as equally safe and "functionally equivalent. Many plan to let patients choose which agent they prefer. European cardiologists are already prescribing Cialis and Viagra equally to new patients or plan to do so. Sources all plan to try Watson's Oxytrol patch for OAB, and doctors predicted it would capture 27% of their prescriptions within six months. Medicare reimbursement cuts for penile implants will put intense downward pressure on prices soon, but vendors are encouraging doctors to lobby CMS to revoke the change. J&J's TVT remains the most popular vaginal sling, but AMS's new Monarc is attracting attention.
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