Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
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Severe Acute Respiratory Syndrome (SARS) in North America - Quick Pulse
Summary: As of April 3, 2003, most of the cases of SARS continue to be in China/Hong Kong, but the disease has spread to North America and is starting to cause great concern. Canada has become the No. 3 site for SARS with 178 cases (69 probable and 109 suspected), and the U.S. is No. 5.
Propofol Update
Summary: Currently, AstraZeneca and Gensia Sicor/Baxter have the only propofols on the U.S. market, but Faulding/Mayne plans to introduce another within the next 3 years, and several aqueous interesting formulations are in development. However, true generics are not expected until 2015.
Radioimmunotherapeutics for Non-Hodgkin's Lymphoma: IDEC's Zevalin and Corixa's Bexxar
Summary: Compared to six months ago, use of IDEC's Zevalin is relatively flat, and the outlook is for that to continue over the next three to six months. Nearly half the major medical centers questioned are not using any Zevalin at all yet. Distribution, compounding restrictions, cost, reimbursement, formularies, and referral patterns are all affecting use. When and if Corixa's Bexxar is approved, sources plan to use it, mostly by taking market share from Zevalin, though it may also expand the market somewhat.
FDA and ASCO Workshop on Lung Cancer Endpoints
Summary: Time-to-progression (TTP) will not be adopted as an endpoint for lung cancer trials in the near future. Quality of life and patient-report-outcomes are good supporting endpoints, but they also are not ready for use as primary endpoints. Non-inferiority trials, particularly the increasingly common single-arm trials, are difficult to interpret, and the FDA wants strong data, but no specific p-value has been set. Accelerated approvals are likely to be harder to get; ODAC will be more critical of data in these cases, and companies generally will have to have confirmatory studies underway before an accelerated approval is granted. This meeting was not a prelude to either approval or non-approval of AstraZeneca's Iressa.
American College of Cardiology: Drugs
Summary: Pfizer/Pharmacia's Inspra (eplerenone) convincing for heart failure, but the cost and need for hyperkalemia monitoring may make it a substitute for spironolactone but not expand the market very much unless Pfizer makes a real commitment to marketing it. Use of Scios/J&J's Natrecor was expected to continue to increase, but a study raised new concerns about safety that may chill use. Cath labs are increasing their use of The Medicine Company's Angiomax and several are planning to switch to it 100%. Schering-Plough's Zetia was shown to lower CRP and is gaining popularity. There is real excitement about AstraZeneca's warfarin replacement, Exanta, but not much about Crestor, Biovail's CCB Cardizem LA or Mylan's beta blocker nebivolol.
American College of Cardiology: Drug-Eluting Stents
Summary: More positive news for J&J Cypher stent, and the delay in FDA approval didn't dampen enthusiasm. Boston Scientific is poised to be the No. 2 entry, and its TAXUS data is holding up, though questions/worries abound. Guidant continues to stumble with a recall of its new Vision stent in Europe, an undetermined problem with its own everolimus program, and regulatory hurdles that may make it difficult to bring Biosensor's everolimus-eluting stent to the U.S. Medtronic is quietly working on its ABT-578 program and may start a U.S. pivotal trial in September 2003. Drug-eluting stents appear cost-effective in the long-term, and cath labs are prepared to bite the bullet in the short term, but pricing may be a significant factor when multiple drug-eluting stents become available.
American College of Cardiology: Non-Stent Devices
Summary: The news also was good for Guidant, with the COMPANION trial confirming the value of CRT and, even more, CRT-D. However, CMS' lack of decision on reimbursement for ICDs using the MADIT-II indication continues to overhang the field. BNP testing is increasing, and doctors generally don't care which test is used - BNP or pro-BNP. With the entry of new BNP tests, BNP testing appears poised to move from point-of-care to analyzer testing, though a niche market is expected to remain in the ER and ICU. This is bad news for Biosite, but good news for Roche as well as Abbott and Dade-Behring, which also have BNP analyzer tests in development.
American Academy of Dermatology
Summary: Johnson & Johnson's Remicade may be the most effective biologic for psoriasis, but dermatologists are not interested in an infused drug, so Amgen's Enbrel is the big winner. There is little interest in either Biogen's Amevive or Genentech's Raptiva. Novartis' oral pimecrolimus could prove a spoiler for all the biologics; the Phase II data was good, but success hinges on the Phase III trial which doesn't begin until 2004. Allergan's oral tazarotene, a retinoid for psoriasis, may replace Roche's Soriatane because it appears equally efficacious but safer. A number of new cosmetic filler products have recently been approved by the FDA or are pending approval, with Medicis' Restylane getting the most attention.
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