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© 2002
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January 2002 issues (click links below for full story)
Angina Update: CV Therapeutics' Ranolazine
Summary: The first new angina treatment in more than a decade is on the horizon. Results from two Phase III trials of sustained release ranolazine have been positive, and CV Therapeutics is expected to file an NDA sometime in 2002. Cardiologists are cautiously optimistic but not enthusiastic about ranolazine, and there may be FDA questions about trial design and QT prolongation.
BiVentricular Pacing Update
Summary: It appears that the FDA has reservations about biventricular pacing technology and wants to see more convincing data. In this environment, requests for patient expanded access to trial devices are on-hold, and Guidant's ability to get approval of the Contak-CD without an additional clinical trial is questionable. Much will hinge on the outcome of the March 2002 FDA Advisory Panel on Medtronic's InSync-ICD.
Drug-Eluting Stent Update
Summary: Cook has taken the lead in the drug-eluting stent rate, filing for European approval of its paclitaxel-eluting stent. However, Johnson & Johnson is not far behind, and, with 0% restenosis, sources still believe this will be the "best" in the class. Meanwhile, Boston Scientific has had a setback; the FDA refused to approve the company's plan for a Phase III trial of its paclitaxel-eluting stent.
Eyecare Trends
Summary: The contact lens company likely to see the most increase in business over the next six months is Johnson & Johnson/Vistakon, with Novartis/ CibaVision mostly likely to lose market share. Bausch & Lomb is still struggling, with no improvement in sight. Among glaucoma medications, both Allergan's Lumigan and Alcon's Travatan are expected to continue to take market share from Pharmacia's Xalatan, with Travatan the apparent favorite. Pharmacia's Xalcom may be a good idea, but doctors are not convinced it will have significant advantages over Xalatan. Inspire's dry eye therapy, INS-365, failed in a Phase III trial.