May 2009 Issues

World Vaccine Conference

Summary: Vaccine growth will be ~8% annually over the next 10 years, driven by expansion into new disease targets – particularly cancer, dengue fever, Alzheimer’s disease, and tick-borne disease – and broader age groups vaccinated with current vaccines. ♦ The 2009 swine flu epidemic will spur even more investment in pandemic research. ♦ The major threats to the U.S. vaccine market are increasing regulatory safety requirements and a growing anti-vaccine movement. ♦ The U.S. economic stimulus package will add some short-term funds to pandemic vaccine manufacturers. ♦ Vaccine manufacturers are watching the possibility of a pathway for biosimilars in the U.S., but that is not discouraging them – yet. ♦ Manufacturers are confident there will be sufficient supply of pandemic and seasonal flu vaccines for the next flu season. ♦ GlaxoSmithKline was recognized as having the best vaccine pipeline; Sanofi Pasteur partners on almost everything, and Merck is doing more partnering; Novartis believes the future is vectors, adjuvants, and cell culturebased vaccines; Wyeth is waiting for FDA approval of a revised Prevnar vaccine. ♦ The outlook for the biologic market is good, although manufacturers worry about the high cost of research. ♦ New technologies to watch include reverse vaccinology, new administration methods such as nasal sprays and patches as well as new manufacturing processes.

American Pain Society (APS)

Summary: Pain specialists are worried that FDA efforts to limit abuse, misuse, and overdose with long-acting opioids will result in access problems for pain patients, and FDA plans to impose a risk management program for these drugs was an underlying theme at the meeting. This has also caused a lull in new drug development, though the risk management program probably won’t go into effect until 2010. FDA officials insisted that approvals are not being held up to wait for finalization of this program. ♦ Immediaterelease opioids are still getting approved, like Johnson & Johnson’s Nucynta (tapentadol IR), but the FDA does not appear willing to grant an abuse-resistant/ deterrent label to any of the new formulations – and there are quite a few vying for that label. ♦ Pfizer’s nerve growth factor, tanezumab, looks very interesting and may be a game changer. ♦ There are now three drugs to treat fibromyalgia, but it is a difficult disorder to treat, and Forest/Cypress has been slow to get its marketing push for Savella (milnacipran) going.

Healthcare Information and Management Systems

Summary: The economic stimulus package is giving new life to IT vendors, but it may be the end of 2009 or early 2010 before this translates into real sales. ♦ Hospital IT budgets are not yet getting much of a boost from the stimulus package; rather CIOs are reallocating existing money. CIOs are waiting to find out what the system requirements are to qualify for the incentives, and this is causing a bit of a pause in purchasing. ♦ Even the CMS incentives are not causing doctors to rush to buy an EMR. ♦ Athenahealth’s web-based EMR is an interesting option for doctors, but the company hasn’t been very successful in selling it to its existing installed base of billing system customers. ♦ eClinicalWorks has started to sell its ambulatory EMR through Sam’s Club for very small practices (1-3 doctors).

Eye Care Update #2

Summary: The economic downturn is hurting optometrists, with patients skipping appointments and stretching how long they wear their contact lenses. Patients also are not upgrading or buying as many accessories. ♦ Contact lens fittings are down very slightly vs. 6 months ago, but they are expected to hold steady over the next 6-12 months. ♦ Prescriptions for oncedaily soft contact lenses are up. ♦ Contact lens manufacturers have increased their incentives, with CooperVision the most aggressive, and that appears to be paying off because CooperVision is gaining market share with Biofinity and Avaira silicone hydrogel lenses at the expense of both Bausch & Lomb and Johnson & Johnson/Vistakon. ♦ Abbott Medical Optics (AMO) appears to have a winner with its new, over-the-counter dry eye drop, blink Tears. Use of Allergan’s prescription Restasis is stagnant, primarily because of cost. ♦ Optometrists are dragging their feet on electronic medical records, and half never plan to adopt EMRs.

Swine Flu Update -- Quick Pulse

Summary: On April 27, 2009, the White House declared a Public Health Emergency due to an outbreak of H1N1 flu in Mexico that spread to the U.S. and elsewhere. Initially, this flu was referred to as the swine flu or the Mexican swine flu, but pig farmers and pork producers complained about the nomenclature since the flu doesn’t come from and is not spread by eating pork. Thus, the politically correct name is now the (influenza A) H1N1 flu.

American Society for Laser Medicine and Surgery (ASLMS)

Summary: The recession continues to cripple the aesthetic laser business, with business down 40%-50%. While a few industry sources believe that business has hit bottom, doctors did not have any plans for big purchases. Rather, U.S. surgeons and dermatologists are making do with their current lasers, not buying new ones. Very few are even buying handpieces or other accessories. However, doctors from other countries were doing some shopping. ♦ Patients want procedures that are quick and cost effective. They are opting out of larger ticket procedures, and any money they are spending goes for Allergan’s Botox, hair removal, or laser-assisted lipolysis (LAL). ♦ Technology is advancing only incrementally. The greatest interest was in fractionated CO2 non-ablative devices and, to a lesser extent, laser-assisted lipolysis. Doctors are also interested in non-ablative therapy and minimally invasive devices. ♦ Future devices include radiofrequency and high-powered LED machines, although these are still in the early stages of development (and don’t appear to work very well). ♦ Solta continues to lead in fractionated CO2 devices, but doctors do not like disposables, and that may hurt Solta in the long term. ♦ Fat “melting” is gaining popularity as well as tightening without surgery and other procedures with minimal surgical intervention.