February 2011 Issues

American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU)
Summary:A study found that prostatectomies with Intuitive Surgical’s da Vinci robot should be restricted to high volume doctors/centers. ♦ Demand for immunotherapy with Dendreon’s Provenge is expected to increase – and treatment delays shrink – as new plants come on line. ♦ Medical oncologists are very excited about Exelixis’s cabozantinib (XL-184) because of its “dramatic” effect on bone mets and pain, but toxicity is a concern. ♦ OncoGenex/Teva’s custirsen may be the dark horse, with low awareness but very good Phase II results that need confirmation from an ongoing Phase III trial. ♦ Doctors are anxious to use Johnson & Johnson’s abiraterone and/or Medivation/Teva’s MDV-3100 – and to use them pre-chemotherapy – but they haven’t figured out how to sequence them with Provenge yet. ♦ Doctors are not enthusiastic about Amgen’s Xgeva, sticking with Novartis’s Zometa, though Xgeva may slowly gain usage.

FDA to Get Tougher on Accelerated Approval of Oncologic Drugs -- Quick Pulse
Summary:The FDA’s Office of Oncology Drug Products is committed to the accelerated approval process for oncologic drugs, but it wants to tighten the postmarketing aspect of the program to make it work better. After a day-long discussion, the FDA’s Oncologic Drugs Advisory Committee (ODAC) agreed that changes are needed, particularly to the postmarketing commitment studies that companies are required to perform to convert accelerated approval into full approval.

Angiogenesis, Exudation, and Degeneration 2011
Summary: Roche/Genentech’s Avastin has 60% of the VEGF market for wet AMD vs. 40% for Lucentis, and the CATT trial is unlikely to change this unless the results are unexpectedly dramatic. ♦ New Phase III data in wet AMD for Regeneron’s aflibercept (VEGF Trap-Eye) looked very good, showing non-inferiority to Lucentis with all dosing regimens, including Q8W, and 43% of doctors said Trap would be their preferred anti-VEGF if Medicare pays for it and the cost is less than or equal to Lucentis. It is also likely to be used in Avastin/Lucentis failures. ♦ No Medicare national coverage decision on VEGF drugs is expected unless someone requests one for aflibercept, in which case CMS would review all three VEGF inhibitors. ♦ Glaucoma is an increasingly common side effect of anti-VEGF therapy and appears related to the number of injections. ♦ Ophthotech has three drugs for AMD that look interesting. Radiation therapies are getting a watchful eye but not much enthusiasm, and the regulatory outlook is questionable. Doctors also aren’t very enthusiastic about Alimera Sciences’ Iluvien fluocinolone implant for DME.

Advances in Genome Biology and Technology (AGBT)
Summary:Translating genomic research into clinical applications is moving slowly. Doctor education is a hurdle, but oncology patient demand may drive adoption. ♦ Sequencer sales are strong, despite cuts in NIH grants. ♦ Illumina customers are switching out their GA-IIs for HiSeqs, which will increase the number of samples run in labs and lower the per-base cost but increase overall consumable expenditures. ♦ There is no enthusiasm for a new Roche 454 or Life Technologies SOLiD, but labs are very interested in Pacific Biosciences’ SMRT RS. ♦ Life’s Ion Torrent (because it is first) and Illumina’s MiSeq (because prep is faster) are starting to get some attention. ♦ Outsourcing and cloud computing are finding a niche.

Eye Care Update
Summary:Despite the recession, things are lookingbetter for optometrists, and most are planning to spend money in 2011 on electronic medical records and/or new equipment. ♦ Allergan’s Lumigan 0.01% appears to cause less red eye than Lumigan 0.03%,so it is catching on. More than a third of Lumigan patients are now on 0.01%, and that is expected to increase during 2011. Use of Allergan’s Alphagan, Alphagan-P,and Combigan is relatively flat, another trend likely to continue. ♦ Generic Xalatan is expected to expand the number of patients on a prostaglandin, but it also will cannibalize Lumigan and, to a lesser extent, Travatan. ♦ Referrals for refractive surgery are down 8.1% year-over-year, and the out look is for a flat 2011, but price cutting may be bringing more patients in for a procedure. ♦ Patient compliance and cost continue to limit use of dry eye medications. Use ofAllergan’s Restasis is down a little from last year, but use may increase slightly during 2011. There is little interest in TearLab’s new test for diagnosing dry eye. ♦ Use of Allergan’s Latisse to lengthen eyelashes is increasing, and patient satisfaction is high.