American College of Rheumatology

Abbott\'s Humira (D2E7) is poised for a strong launch, and it is likely to take share from Remicade but even more from Enbrel. The number of patients waiting for Enbrel supply to improve may be far smaller than Amgen estimates, and the company\'s credibility has been hurt with some doctors. The Phase II data was positive for Bristol-Myers Squibb\'s oral CTLA4Ig. Idec\'s Rituxan looks promising, with an effect that lasts six-months, but safety remains a concern, and the FDA is likely to require long term (3 year) trials. Preclinical data on Scios\' p38-MAP kinases looks promising, but it is still very early. Use of Merck\'s Vioxx is expected to continue to decline due to publicity about cardiac toxicity, with Pfizer\'s Bextra picking up share.

Drug Eluting Stents Move a Step Closer

An FDA advisory panel voted 8 to 0 on October 22, 2002, to recommend approval of the Cypher drug-eluting stents. The panel recommended only about one-fourth of the sizes that J and J requested, but label expansions will not require large, prospective trials. Brachytherapy is likely to be contraindicated in patients with a drug-eluting stent. The PDUFA date has been pushed back to April 21, 2002, because a Major Deficiency letter was issued on manufacturing issues, though the FDA is working with J and J to resolve this sooner. Final approval will depend upon resolution of several issues that may delay action on this product: a Major Deficiency letter, other manufacturing issues, shelf life and labeling (which an FDA official said the agency is \"a fair ways away\" from finalizing).

FDA Advisory Panels: When One is Not Enough

It is not common for a drug to go before two FDA Advisory panels before a final decision is made to approve or disapprove a drug. However, the decision is not random chance, and the FDA may take a drug to a second panel if for drugs when: ♦  They are first-in-class.   There are questions of science.   The company requests it.   The first panel recommends it.   Something new or controversial came up.   A political issue in the medical community is involved.

Contact Lens Update

Toric lens sales are up and average of 8% year-to-year, and the outlook is for sales to increase an average of 6% over the next 12 months. Performance is the key factor in the selection of a toric lens. CooperVision, especially its new Encore toric lens, is the up-and-comer, taking market share at the expense of Bausch & Lomb. Colored contact lens sales are up an average of 6% year-to-year, and the outlook is for sales to increase an average of 3% over the next 12 months. Novartis\' CIBA Vision/Wesley Jessen is the top vendor of colored cosmetic lenses, though colored lenses from Ocular Sciences (OSI) and Johnson & Johnson/Vistakon are getting a little more attention. J&J/Vistakon and CooperVision sales reps were ranked the best, with B&L the worst. The opinion of Ciba/WJ sales reps has declined over the past year. Optometrists keep little or no inventory of toric or colored lenses, depending on trial sets to sell these lenses.

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).

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