Hormone Replacement Therapy

The government.s decision to terminate the Prempro arm of a major clinical trial has women worried, and they are being inundating their doctors with telephone calls. Many want to stop HRT, and doctors seem to agree . especially for women who have been on it for a long time. Doctors will still recommend HRT for some new patients whose symptoms are severe, but mostly for short periods of time. The outlook is for HRT use to drop drastically, perhaps as much as 50% over the next year. This is generally viewed as a class problem, and Wyeth.s Premarin and Prempro are likely to decline in proportion to the overall market. While this is not a short-term problem, most sources do not believe it will become the litigation nightmare like the Dalkon Shield and silicone breast implants.

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.

American Society of Hypertension

Edema may not be a serious problem with CCBs, but it is bothersome, and that should make Forest Laboratories\' lercanidipine a winner since edema is significantly less with lercanidipine than with Pfizer\'s Norvasc. There\'s no excitement about Forest\'s Benicar, and doctors see it primarily as a me-too drug in a crowded ARB market. There also is no enthusiasm for either Pharmacia\'s Covera HS or Biovail\'s Cardizem XL. Doctors either consider chronotherapy a gimmick, or they already are prescribing other antihypertensive medications at bedtime and see no need for these agents. Pharmacia\'s eplerenone is expected to appeal mostly to heart failure patients, diabetics and African-Americans. Half the doctors questioned are very concerned about the hyper-kalemia side effect with eplerenone. A cheaper, generic lisinopril is likely to appeal to managed care, but King\'s Altace is predicted to gain further market share.

American Psychiatric Association

It was a positive meeting for:Bristol-Myers Squibb\'s new antipsychotic, Abilitat (aripiprazole), Forest Labs\' new SSRI Lexapro (escitalopram), and Johnson & Johnson\'s Risperdal, which has seen a resurgence in use due to the problems that have arisen with Lilly\'s Zyprexa. Doctors also are excited about the new IM version of risperidone (Consta) that is expected to be approved by the FDA later this year. Lilly appears to have several winners in develop-ment, including atomoxetine for ADHD, duloxetine for depression and the anxiolytic mGLuR, but the outlook for Zyprexa and OFC (combination Zyprexa+Prozac) is more iffy. Merck continues to have the lead in NK-1s with its Substance P for anxiety, pain and depression. Questions still remain about the oncogenicity of Pfizer\'s pregabalin. CRF antidepressants are a promising area of research, but it is not clear which company has the lead.

EuroPCR: Paris Course on Revascularization

The news was mostly good for Johnson & Johnson and Guidant, mixed for Boston Scientific, and too-early-to-tell for Medtronic and Abbott. The preliminary nine-month SIRIUS data showed a 2% in-stent restenosis rate, and a 9.5% in-segment restenosis rate. European cardiologists are anxious to use Cypher stents, but there is little or no reimbursement and that is hampering usage. In the TAXUS trials, restenosis appears to be low, but aneurysms were found, though they are not included in MACE reports due to a lack of clinical effect - yet. Medtronic and Abbott may be trying to convince the FDA to let them skip Phase I and II trials and go directly to a pivotal Phase III trial of ABT-578. The 30-day MACE rate in Guidant\'s Deliver paclitaxel trial was low, but sources continue to be dubious that this product will be successful.

Association For Research in Vision and Ophthalmology

Numerous new therapies are under investigation, but the most promising - and closest to market - are Alcon\'s anecortave and Bausch & Lomb\'s Envision TD. Anecortave looks as if it could give QLT\'s Visudyne a run-for-its money in AMD treatment, though there are still questions about efficacy and side effects. There was little new information at this meeting on Envision, a back-of-the eye therapy for diabetic macular edema and posterior uveitis. The prostaglandin marketing wars continue, and the hyperemia issue with Allergan\'s Lumigan is causing doctors to look harder at Alcon\'s Travatan, with use of both Lumigan and Travatan increasing at the expense of Pharmacia\'s Xalatan. No pickup is in sight this year for refractive surgery.

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.

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