March 2007 Issues

World Vaccine Conference -- Quick Pulse

Summary: The World Vaccine Congress brought together about 300 experts in the vaccine field, including manufacturers, contract research organizations (CROs), contract manufacturing organizations (CMOs), and device and service companies that work with those companies. It was an opportunity for them to share the status of various vaccine projects and ideas for future development.

Cariovascular Revascularization Therapies (CRT)

Summary: Drug-eluting stent ( DES ) penetration has dropped to ~70% of procedures, and interventional cardiologists expect it to drop further before bottoming and bouncing back a little. ♦ The COURAGE trial, to be released soon, is expected to show that PCI is no better than medical management, and that may affect use of stents as well. ♦ Medtronic’s Endeavor and Abbott’s Xience stents are likely to face little or no delay in FDA approval because of the stent thrombosis issue, but other new DES may experience delays. The FDA is preparing new guidance on requirements for DES approvals, and this is expected to mandate: longer and larger trials, more “real-world” patients, and clinical endpoints. ♦ Despite pleas from interventional cardiologists to loosen approval requirements, the FDA remains adamant that randomized clinical trials are required for approval of PFO closure devices and percutaneous heart valves. ♦ Doctors were speculating about possible future CMS restrictions on reimbursement for PFO closure devices and off-label DES use.

Parkinson's Disease Drug Pergolide Voluntarily Withdrawn from Market -- Quick Pulse

Summary: The FDA announced that manufacturers have agreed to a voluntary withdrawal of pergolide because of reports of heart valve damage. Pergolide is an ergot-derived dopamine agonist (DA) sold by Valeant Pharmaceuticals as Permax and generically by Teva Pharmaceuticals, Ivax, and Parr. It is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

FDA Issues Public Health Advisory on Erythropoiesis-Stimulating Agents (ESAS) -- Quick Pulse

Summary: On March 9, 2007 , the FDA put a black box warning on all currently approved erythropoiesis-stimulating agents (ESAs) − Amgen’s Aranesp (darbepoetin alfa), Amgen’s Epogen (epoetin alfa), and Johnson & Johnson’s Procrit (epoetin alfa), all of which are manufactured by Amgen. The Agency also revised the product labels for these drugs, with updated warnings and modifications to the dosing instructions, and it warned physicians to use as little of them as possible.

Cardiac Surgery Update

Summary: Cardiac surgeons are doing more heart valve repairs, which hospital administrators sometimes encourage because repairs are cheaper than replacements. ♦ St. Jude’s Biocor tissue valve appears to be taking market share from Edwards’ Perimount, with some significant discounting by St. Jude reported. ♦ Cardiac surgeons are increasingly interested in treating atrial fibrillation during valve and other open heart procedures. Bipolar radiofrequency (RF) often with cryotherapy is the preferred technology. AtriCure’s bipolar RF is getting attention, and the company plans to introduce an interesting new bipolar RF device, but surgeons already using Medtronic’s bipolar RF are satisfied with that. Yet, both ships may rise with the growing AFib treatment tide. ♦ Most cardiac surgeons have accepted the idea that percutaneous valves are coming, and they are starting to get cross-trained in catheter procedures. ♦ Use of Intuitive Surgical’s DaVinci robots continues to be driven primarily by urology and gynecology; there was little interest in stand-alone robots for cardiac surgery.

FDA Panel Unanimous: Randomized Trial Required for PFO Closure Devices

Summary: For the third time, an FDA advisory committee told manufacturers that there is no substitute for a randomized clinical trial of PFO closure for stroke patients, and they expect the ongoing trials to be completed. ♦ The panel said minor protocol changes – in randomization schemes, enrollment criteria, and enrollment time frame – might be acceptable, but only with a statistical penalty. ♦ Reducing the total number of patients in the trials would not be acceptable. ♦ Slow enrollment in the ongoing trials has been due to off-label device use and patient and physician preferences, and the panel suggested medical societies help boost enrollment by educating patients and physicians.

Pittsburgh Conference (PITTCON) 2007

Summary: Pharma spending for 2007 is predicted to be flat but may be offset somewhat by increases in generic, CRO, small/medium-sized pharma, and biotech spending. ♦ The pricing environment is “pressured,” and there is a lot of discounting and dealing going on but no price war. ♦ The mass spec market is healthy and picking up steam in the clinical lab setting. ♦ Agilent’s new high end triple quad (6410) is no serious threat to Waters high end triple quad, even with a 20% lower price, but it may lure single quad users up to a triple quad – if they don’t opt for the Applied Biosystems’ promotion, a lower-end triple quad for the price of a single quad, which underprices Agilent. But Agilent’s strong base in GC and LC should help sales of its triple quad. ♦ Some sources are leery of Waters’ Synapt, calling it a device in search of an application. ♦ Sales of ThermoFisher’s FTMS “plummeted” with the entry of the Orbitrap, and the Orbitrap market may be getting close to saturation. Customers are worried about Thermo’s ability to integrate Fisher, and some are reporting service and delivery problems. ♦ The hottest new technology on the horizon is Agilent’s LC-on-a-chip, but it is still a couple of years away from the breakthrough use that customers and the company envision. ♦ Millipore remains the gorilla in water purification.