American Academy of Ophthalmology

The refractive surgery (LASIK) market is stalled, and the outlook isn\'t for a quick pickup. Wavefront technology was a hot topic and is likely to catch on, but it won\'t boost procedure volume any time soon. Interest is growing in InterLase\'s laser for creating LASIK flaps. C&C Vision, ThinOptX and Calhoun Vision all have implantable IOLs that look interesting and deserve watching. Alcon probably will not be able to use the C-98-03 trial data as a confirmatory study for FDA approval of anecortave, which means it will need positive results from both the pivotal Phase III and the European registration study for FDA approval. Six-month data may be enough for FDA approval of Bausch & Lomb\'s back-of-the-eye steroid implant, Envision, in uveitis but longer term data probably will be required for macular degeneration and diabetic macular edema.    

American Society For Bone and Mineral Research

Doctors consider the various bisphosphenates fairly equivalent, though dosing and administration regimens vary, and less frequent dosing may have advantages. However, bisphosphenate use is likely to increase as doctors pull back from hormone therapy after the findings of the Women\'s Health Initiative. Doctors are excited about parathyroid hormone (PTH), but most plan to use it only for selected, high risk patients with significant osteoporosis. Amgen/NPS Pharmaceuticals\' calcimimetic, AMG-073, which is in Phase II trials, looks promising. NPS/GlaxoSmithKline\'s calcilytic is further away but also worth watching. 

2002 Retina Congress

Sources remain dubious about the outlook for Bausch & Lomb\'s back-of-the-eye steroid implant, Envision. Bristol-Myers Squibb\'s Kenalog was the hottest topic at the 2002 Retina Congress, and it\'s being used to treat almost everything - posterior uveitis, AMD, DME, and more. Doctors are disappointed with Novartis/QLT\'s Visudyne, and many are doing TTT off-label for AMD, but doctors are split on its safety and effectiveness. The new product that got the most positive reception was Genentech\'s VEGF, rhuFAB-V2. The 12-month data on Alcon\'s anecortave was well-received, but there was little critical or in-depth discussion, and most doctors did not even realize that there were significant dropouts in the trial.

Using Time-to-Progession as a Clinical Trial Endpoint

 Uncertainty over the best endpoints for a clinical trial is not limited to researchers. Even the FDA has been holding internal meetings to discuss appropriate endpoints, particularly in oncology trials. The FDA has approved drugs based on trials with a time-to-progression (TTP) endpoint, but it is a high hurdle, and the agency has no immediate plans to issue guidelines on the use of TTP endpoints. TTP is less precise than survival, and it raises questions -- about patient selection, cherry-picking, bias, measurement interpretation, the comparator, etc. - that must be answered.

European Respiratory Society - Stockholm, Sweden

Intermune impressed doctors with the significant survival benefit in a subgroup analysis of its Phase III trial of Actimmune (interferon-g), even though that drug failed its primary and secondary endpoints. Pfizer and Boehringer-Ingelheim were aggressively and successfully marketing their new COPD treatment, Spiriva (tiotropium). New data was presented on the antimicrobials, telithromycin (Aventis\'s Ketek) and moxifloxacin (Bayer\'s Avelox), but there was little excitement about either of them.

European Society of Cardiology - Berlin, Germany

Nine-month safety data from the SIRIUS trial showed Johnson & Johnson\'s sirolimus-eluting Cypher stent is safe, and use is increasing in Europe Achieve, Guidant\'s paclitaxel-eluting stent, got CE Mark during the meeting, but there was little enthusiasm for it, mostly due to insufficient data. Biosensor is in human trials of its everolimus-eluting stent and may apply for CE mark in early 2003. AstraZeneca\'s Crestor beat out Pfizer\'s Lipitor across all dosage ranges, and doctors indicated it may do well - if it performs well clinically. Pharmacia announced that the EPHESUS trial of its anti-hypertensive, eplerenone ended, with data expected at ACC2003. The concern with hyperkalemia appears to be waning. Cardiologists are not convinced of the utility of Zetia, Schering Plough\'s new cholesterol absorber, and the problem is lack of outcomes data more than need to take two pills (Zetia plus a statin).

The Outlook for Prilosec and other Proton Pump Inhibitors

An FDA panel has recommended that the agency approve P&G’s Prilosec-1, an overthe- counter tablet version of Prilosec (20 mg omeprazole), and it is likely the FDA will follow this advice. Meanwhile AstraZeneca is trying to defend its Prilosec patent in court against generic manufacturers. A court decision is expected within the next couple of months, and the outlook is for the generics to prevail. When OTC Prilosec and generic omeprazole are both available, managed care companies expect broad usage of both – at the expense of all the brand proton pump inhibitors. Generics will replace Prilosec on formularies, but managed care companies also expect convenience, couponing and advertising to drive OTC use.

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.

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