Angina Update: CV Therapeutics' Ranolazine

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

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

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

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.      

American Academy of Dermatology Psoriasis Update

Dermatologists have started using Johnson & Johnson’s Remicade and Immunex’s Enbrel off-label to treat psoriasis, and the data on these agents looks very good. The outlook for other biologic agents in psoriasis is more questionable. Genentech/Xoma’s Xanelim has a problem with rebound on and off drug, and Biogen’s Amevive depresses CD4 counts. Both Amevive and Xanelim are likely to face intense regulatory scrutiny.

Drug-Eluting Stents: XXIII European Society of Cardiology

Johnson & Johnson got a huge win with its sirolimus-eluting stent, Cypher. The RAVEL data showed zero restenosis at six months. In contrast, a suggestion has been made that paclitaxel-eluting stents are pro-thrombotic, and researchers do not believe any of the other drugs under investigation for use with a stent will be as good as sirolimus. The most interesting agents to watch may be Guidant’s actinomycin and Bayer’s cerivastatin, as well as oral rapamycin and paclitaxel.

North American Association for the Study Of Obesity (NAASO)

Obesity specialists are excited about Sanofi-Aventis’s Acomplia, and it is likely to boost pharmacotherapy, even among doctors currently doing little or no drug treatment, but there are still unanswered questions about this agent, and it is unlikely to get a label to treat metabolic syndrome, at least initially. ♦ Patients also may be excited about Acomplia at first, but that may be followed with disappointment in the degree of weight loss. ♦ Numerous other anti-obesity drugs are in development but none are on the near horizon. ♦ Bariatric surgery has been increasing exponentially, and the growth is likely to continue, but perhaps not as fast due to payer resistance. Sources predicted use of Inamed’s Lap-Band will double over the next year.

Update on Cholesterol Lowering Medications from XXIII European Society of Cardiology and Drugs Affecting Lipid Metabolism (DALM)

AstraZeneca’s Crestor (rosuvastatin) was shown to be more effective than Pfizer’s Lipitor (atorvastatin), but safety questions remain. The recent withdrawal of Bayer’s Baycol (cerivastatin) – and the lack of a clear understanding of what caused the problem with cerivastatin -- has made doctors and regulatory authorities nervous about new agents, so the outlook is for a possible delay in approval of Crestor and a slower-than-expected launch. Schering Plough’s cholesterol absorption inhibitor, ezetimibe, may be the big beneficiary of the Baycol withdrawal. The drug was shown to lower cholesterol either as monotherapy or in combination with a statin, with no serious side effects, and it may be more appealing to doctors than a “superstatin.”

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