March 2008 Issues

American Society of Clinical Oncology (ASCO) 2008 Gastrointestinal Cancers Symposium

Summary: K-ras may prove to be a marker for response to EGFR inhibitors, but doctors aren’t ready to start K-ras testing, in part because there is no commercially available test. ♦ Use of Imclone’s Erbitux is growing slowly but steadily, but there is game-changing data coming at ASCO 2008. ♦ Oncologists were taking a more subdued or reasoned approach to Genentech’s Avastin in various cancers. ♦ The news was positive but not dramatic about Bayer/Onyx’s Nexavar. U.S. doctors are divided on how long liver cancer patients should stay on it; some treat through progression, and others stop on progression. The outlook in Asia will depend on reimbursement. ♦ The data in GIST for Novartis’s Gleevec were described as “remarkable.” ♦ Worldwide safety and efficacy data on Pfizer’s Sutent showed no new toxicity and expected efficacy, but Pfizer’s tremelimumab failed in gastric and esophageal cancer. ♦ Taiho/Sanofi-Aventis’s S-1, an oral 5- FU, looks promising, but there is concern that the Japanese data are not sufficiently rigorous, and American doctors want to see the results of the ongoing U.S. trial in gastric cancer. ♦ Genomic Health has a genomic assay in development for CRC similar to its breast cancer test, Oncotype DX.

Stent Update -- Quick Pulse

Summary: Directors and managers of 15 cardiac cath labs across the U.S. were interviewed to check on stent trends, particularly drug-eluting stents ( DES ). Medtronic’s Endeavor was approved on February 1, 2008 , but there appears to be little enthusiasm for it. In contrast, there is a good deal of excitement about Abbott’s Xience V (which will also be sold by Boston Scientific as Promus), which is expected to gain FDA approval by summer.

Cardiovascular Revascularization Therapies ( CRT )

Summary: Interventional cardiologists want both PCI and DES volume to start increasing again, but there were no real signs that this is happening, and the FDA is raising the bar for new DES . ♦ There was more excitement about Abbott’s not-yet-approved Xience V than Medtronic’s newly-approved Endeavor, and doctors predicted that Endeavor would take <10% market share but Xience could capture “significant” market share, affecting Boston Scientific’s Taxus and Johnson & Johnson/Cordis’s Cypher almost equally. ♦ Percutaneous valves remain a technically challenging procedure. The regulatory path is almost as challenging, and it doesn’t appear to be getting simpler. ♦ European doctors haven’t been able to choose between Edwards Lifesciences’ Sapien THV and CoreValve’s ReValving System percutaneous aortic valves, and use of both is still limited. A new problem has emerged: patients needing a permanent pacemaker post-valve implantation.

FDA Advisory Committee Recommends Keeping Anemia Drugs on the Market but with New Limits

Summary: An FDA Advisory Committee voted that ESAs should remain available to cancer patients with chemotherapy-induced anemia but that patients receiving potentially curative treatments (such as adjuvant breast cancer patients) should not take them. The panel favored stronger written informed consent, but rejected the idea of a restricted distribution system. The panel was divided on whether ESA use should be restricted to small cell lung cancer patients only and on whether patients with metastatic breast and/or head & neck cancer should take ESAs. Some panel members favored using hemoglobin ≤10 for ESA initiation in asymptomatic patients without comorbidities, but others wanted more physician discretion.

American Academy of Orthopedic Surgeons

Summary: Falling reimbursement may cause a shortage of orthopedic surgeons doing joint replacement surgery at the same time that demand is increasing, and this could affect company growth predictions. ♦ Gender-specific hips and knees are both viewed as a marketing gimmick. ♦ Many orthopedic surgeons are dubious about hip resurfacing, many of those who perform it believe it should be restricted for ≤10% of hip patients – mostly younger men. Doctors are somewhat more optimistic about knee resurfacing. ♦ Stryker does not appear to have lost much if any market share due to its problems with Trident hip manufacturing or the government subpoena on its foreign trade practices, and its hip resurfacing system may take some share in that small market. ♦ Government investigations of the orthopedic industry – and surgeons themselves – are not over, but the investigations do not appear to be affecting brand loyalty, at least not yet. Likewise, the decrease in consulting agreements or the amounts paid to consultants does not appear to be affecting brand loyalty. ♦ Hospital pressure on implant prices and surgeon choice of devices is accelerating.

Heparin Contamination Expands Beyond the U.S.

Summary: The FDA found a contaminant in some batches of the active pharmaceutical ingredient ( API ) used in Baxter International’s recalled heparin sodium, and that contaminant is believed to have been introduced in China . German health officials also reported that they found the same contaminant in some German-made heparin used in their country, but the source of the German heparin has not yet been released, so it is not known if that contamination originated in China .