April 2010 Issues

FDA Advisory Committee Rejects Opioid, Saying Niacin not an Abuse Deterrent -- Quick Pulse

Summary: Acura Pharmaceuticals’ and King Pharmaceuticals’ hopes for Acurox, an oral combination of immediate-release (IR) oxycodone and niacin, got flushed away at a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel voted overwhelmingly (19 to 1) against approval of Acurox. Panel members agreed that Acurox may be effective in preventing abuse by snorting and injection but was not convinced that the flushing side effect caused by the niacin is an effective deterrent to abuse. In fact, many panel members questioned whether the niacin component was appropriate at all since there was no clear advantage to it, and it added side effects.

Cardiovascular Research Technologies (CRT)

Summary: DES are a steady ~two-thirds of stents used, with Abbott's Xience keeping about half the market. PCI volume is increasing somewhat. ♦ U.S. interventional cardiologists anxiously await the first percutaneous aortic valves to be approved, and European use continues to increase. Phase III U.S. data on Edwards Lifesciences' Sapien is expected in September 2010, and Medtronic is preparing to begin its pivotal U.S. trial. The big questions now are:
•     Can they be used in younger, healthier patients? Probably, but the FDA will require hard safety and efficacy data.
•     Will U.S. regulators limit the roll-out? Most likely both FDA and CMS will ensure this.
♦ Abbott/Evalve's MitraClip is already approved in the U.S. and Europe for percutaneous mitral valve repair, but it remains a niche procedure/ product due to time, cost, and expertise required. ♦ IABP shows no mortality benefit but remains the most common hemodynamic support in the cardiac cath lab, with CardiacAssist's Tandem-Heart and Abiomed's Impella remaining important but very niche products. ♦ Lilly's Effient (prasugrel) appears to have found a place in cath labs, but use is not growing much as cardiologists look to newer antiplatelet agents they hope to have soon, such as AstraZeneca's Brilinta. ♦ Use of platelet function testing, particularly Accumetrics' VerifyNow, requires outcomes studies, so doctors will be watching the GRAVITAS trial results this fall.

Pittsburgh Conference (PITTCON)

Summary: Lab budgets are still fairly flat, but the mood at Pittcon was somewhat optimistic. Managers were looking, if not buying. Many labs plan to buy new equipment in 2010 or 2011, even if it’s small items; only a few plan to buy big instruments, including HPLCs and UHPLCs, this year. ♦ Stimulus money does not appear to be turning into many sales yet for tools companies. ♦ Companies generally do not believe that the economic downturn has bottomed out. Although most were upbeat, only Waters claimed to be doing well with sales. Market share did not appear to be shifting. ♦ Attention was focused on UHPLC instruments, which companies were marketing heavily as the next must-have big ticket item. Peripheral vendors were focusing on add-ons for UHPLC, such as filters and valves. ♦ Mass spectrometry has been in a slump, but tools companies hope that will end when labs get stimulus funds. ♦ Company officials insisted that R&D spending is holding steady or even increased. Growth areas include China and food testing. ♦ A positive sign: The Export-Import Bank generated 40%-50% more loan guarantees and loans at Pittcon than last year.

American Academy of Cosmetic Surgery (AACS)
Summary: Volume: Cosmetic procedure volume appeared to have bottomed out and is likely to be relatively flat in 2010 vs. 2009. ♦ Pricing: Price is a big issue with patients, and many cosmetic surgeons are having to lower their prices, but patients are still getting turned down for financing. ♦ Purchasing: Big ticket purchases are being delayed, and financing has gotten much tougher for doctors and takes longer. ♦ Vendors: There has been a lot of merger/ acquisition activity, and that is expected to continue as the industry further consolidates. ♦ Aesthetic lasers: Cosmetic surgeons are unhappy with industry hype about these devices, though they agree they have a place, differ little from each other, and produce only limited results. ♦ Liposuction: The hot new products were Erchonia’s Zerona, a lower power, external laser for body contouring, and Eclipse Medical’s Body-Jet, a water-assisted device. ♦ Fat transfer: Interest and use is growing for breasts, face, and other areas -- at the expense of commercial fillers. Stem cells are an appealing concept, and doctors are looking for ways to improve the amount and quality of stem cells in their fat implants. ♦ Toxins: Medicis’s Dysport, which is priced ~20% less than Allergan’s Botox, has ~16% market share, and that is expected to increase to 22% by next year. ♦ Fillers: Market share appeared fairly steady.