American Association for Cancer Research

Oncologists raised questions about the efficacy of AstraZeneca\'s Iressa, but most believe that it will be approved. Doctors are dubious about the outlook for Genta\'s Genasense in melanoma, multiple myeloma or CLL. Novartis, Kosan Biosciences and Schering AG all have promising epothilones, but Bristol-Myers Squibb appears to have toxicity problems with its epothilone. Anti-angiogenesis agents are still alive, with the small molecules looking more promising than the antibodies. Farnesyl-transferase inhibitors also are alive but perhaps not well, with Schering Plough\'s Sarasar in the lead. New formulations of Taxol got a lot of attention, but the field is getting crowded and doctors are not sure yet of the clinical value of these agents.

American Academy of Neurology

The 48-week Rebif data from the EVIDENCE trial did not wow neurologists. Doctors believe the trial supports use of a high-dose interferon - that is, either Rebif or Betaseron. The outlook is for Rebif to capture up to 15% market share within a year, at the expense of both Avonex and Betaseron, with Copaxone also picking up a little share. Sources predicted that in 12 months the immunomodulatory market would break down: 34% Avonex, 33% Copaxone, 18% Betaseron and 15% Rebif, with Rebif patients coming equally from new patients and from switches. However, Rebif has several hurdles to overcome, including: painful injections, cost, neutralizing antibodies, compliance, and marketing. Thus, Rebif usage may increase as patients try out the newest drug, but then fall off. Biogen\'s Antegren appears safe and effective, and if the data holds up, it could capture significant market share. Cephalon\'s Provigil is catching on as a treatment for the fatigue so common with MS, and doctors predicted usage would continue to increase.

Cardiovascular Radiation Therapy VI and Restenosis Forum II

The pivotal trial of Johnson & Johnson.s sirolimus-eluting stent, Cypher, is not expected to be stopped early, but the FDA could make a quick judgment on the product once the trial is complete . provided there are no manufacturing issues. Malapposition and edge effect concerns do not appear to be a big issue, but the FDA is concerned about the deaths in a European in-stent restenosis trial, so it appears that J&J initially may get a somewhat restricted label. Competition continues to heat up, but doctors remain cautious if not dubious about the outlook for paclitaxel. Medtronic is rumored to have struck a deal with Novartis to develop everolimus, and the regulatory path for a non-approved drug appears to have gotten easier, making this a stronger . though late -- potential entrant. Doctors are now suggesting that patients who have had brachytherapy may not be candidates for drug-eluting stents.

Niacin

Niaspan has increased with the increased attention on HDL levels, but the outlook is for that growth to slow. Doctors are starting to prescribe Advicor, but most are taking a cautious approach to it, and it is likely to cannibalize Niaspan sales rather than expand the market – unless it helps make primary care doctors more comfortable with niacin.

Arterial Closure Devices

There appears to be no growth in the arterial closure device market. Cardiac cath labs said usage has been flat for the past six months, and the outlook is for that trend to continue. Perclose remains the slight favorite, with the rest of the market split fairly closely among AngioSeal, VasoSeal and Duett, though a few labs are eschewing most if not all of these in favor of the Syvek patch.

Cardiovascular Radiation Therapy VI and Restenosis Forum II

The pivotal trial of Johnson & Johnson’s sirolimus-eluting stent, Cypher, is not expected to be stopped early, but the FDA could make a quick judgment on the product once the trial is complete – provided there are no manufacturing issues. Malapposition and edge effect concerns do not appear to be a big issue, but the FDA is concerned about the deaths in a European in-stent restenosis trial, so it appears that J&J initially may get a somewhat restricted label. Competition continues to heat up, but doctors remain cautious if not dubious about the outlook for paclitaxel. Medtronic is rumored to have struck a deal with Novartis to develop everolimus, and the regulatory path for a non-approved drug appears to have gotten easier, making this a stronger – though late -- potential entrant. Doctors are now suggesting that patients who have had brachytherapy may not be candidates for drug-eluting stents.

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.

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.

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