FluMist Moves a Step Closer to Market

MedImmune\'s nasal spray flu vaccine got a positive recommendation from an FDA Advisory Panel, which makes it likely the product will be on the market for the 2003-2004 flu season. However, the panel recommended a narrower age range - 5 to 49 - than the company wanted, and MedImmune officials indicated they will try to convince the FDA to broaden this to include 50 to 64-year-olds.

American Heart Association

 Cardiologists are excited about Schering-Plough\'s Zetia (ezitimibe), and many predicted that it would be even more popular with primary care doctors, but cost and managed care coverage may limit use, at least initially. Mixed data on Alexion\'s pexelizumab. The trial missed its primary endpoint, but there was an unexplained mortality, warranting further investigation. Unimpressive results from CV Therapeutics\' trial of tecadenoson (CV-510). Strong positive results from The Medicine Company\'s REPLACE-2 trial of Angiomax (bivalirudin), but many interventional cardiologists remain leery of it. Most plan to try it, but uptake will be slow, with about 12% of cath lab patients getting Angiomax in 12-months. Pfizer\'s Inspra (eplerenone) is generating little excitement among cardiologists. Long-term post-procedure use of Sanofi\'s Plavix (clopidogrel) is gaining popularity. 

National Institute of Health: Scientific Workshop on Menopausal Hormone Therapy

More and more experts are weighing in on the side of a very limited role for hormone therapy - as short-term therapy for severe symptoms of menopause (hot flashes), not as a preventive for anything. In this environment, hormone therapy use in general - and Prempro use in particular -- is likely to continue to decline. Many clinicians have been slow to accept this message, but the voices are getting more common and louder, and additional data and analyses are expected that should reinforce the message. Although the WHI findings were only with Premarin and Prempro, experts and regulators generally agreed that the findings must be considered to apply to other hormone products until and unless they are shown to be safer.

The Safety of Astrazeneca'a Iressa

AstraZeneca\'s Iressa has been linked to 125 cases of interstitial pneumonia and 39 deaths in Japan, leading to a label change but not market withdrawal. AstraZeneca has downplayed the significance of these reports, and U.S. oncologists do not appear to be not worried about this, with most suggesting it is something unique to Japan. However, FDA officials are likely to be more concerned, and they may require another trial before approving Iressa.

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. 

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