May 2006 Issues

European Association for the Study of the Liver (EASL)

Summary: Protease inhibitors for HCV: Both Schering-Plough’s SCH-503034 and Vertex’s VX-950 appear effective, but q8h dosing could be problematic. Abbott’s Norvir may prove useful as a booster for both of these. ♦ Polymerase inhibitors for HCV: Idenix/Novartis’s valopicitabine (NM-283) has problems both in terms of efficacy and GI and pancreatic side effects. The safer, lower doses (200-400 mg) were effective in naïve but not experienced patients. Roche’s R1626 is in earlier development but does not appear to have the same problems. ♦ Interferons for HCV: Doctors were optimistic about Human Genome Science’s albuferon with Q2W dosing, but Roche’s R7025 also bears watching. ♦ Ribavirin for HCV: Valeant’s viramidine likely will require another trial, which may put its approvable date so far in the future as to make it either unlikely to be pursued or unlikely to be a major product. ♦ HBV: Idenix/Novartis’s telbivudine looks very promising, and so does Anadys’s ANA-380, though it is much earlier in development.   

LASIK Update -- Quick Pulse

Summary: Twelve refractive surgeons, the CEO of a refractive surgery company with multiple centers, and an industry expert were interviewed about trends in refractive surgery. Doctors indicated LASIK procedures during the second quarter of 2006 (April, May, and June) are looking flat compared to the same time period last year and down an average of 5.2% compared to the first quarter of this year.

American Pain Society (APS)

Summary: Cephalon's effervescent fentanyl appears to work quicker than its Actiq for breakthrough pain, but doctors raised a number of questions about the outlook for the product. ♦ The outlook for FDA approval of Endo Pharmaceuticals' oxymorphone ER is clouded by alcohol interaction in humans at high doses, though this was described as not clinically significant. If it gets approved, it will be another option for opioid rotation but could gain first-line status over time. ♦ Adolor/GlaxoSmithKline's alvimopan appears effective in reducing the opioidinduced constipation, and about 25% of opioid patients are expected to get a prescription for it when it is approved. ♦ Doctors predicted that Pain Therapeutics/King's Remoxy will be a niche product because payors are unlikely to pay extra for it. ♦ Doctors were not enthusiastic about combination products like Forest Labs' Combunox and Pain Therapeutics' Oxytrex.

American Academy of Pain Medicine (AAPM)

Summary: Abuse-resistance technology/design is encouraged but not required for FDA approval of an oral ER opioid. ♦ All ER opioids must have in vitro – and sometimes in vivo – alcohol interaction data before FDA approval. ♦ Even opioids with a lower abuse potential than competitors will find it extremely difficult to get a better controlled substance schedule. ♦ Pain doctors are generally receptive to the idea of oxymorphone ER for second- or third-line use. ♦ Doctors want to see functional improvement as well as pain reduction to prove the value of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) in fibromyalgia, but doctors will use it if it gets approved. ♦ Advanced Bionics’ current steering was a hot topic, and the company is likely to increase market share. ♦ Neurostimulation companies have been trying to spur sales by getting the word out about new Medicare reimbursement rates this year for implantable pulse generators. ♦ Worth watching: Javelin Pharmaceuticals’ Rylomine, an intranasal morphine, and Bioness’ Bion, a microstimulator for rehabilitation. ♦