June 2006 Issues

New Clinical Drug Evaluation Unit (NCDEU)

Summary: This annual psychopharmacology meeting, sponsored by the National Institute of Mental Health (NIMH), is usually an excellent venue for reviewing psychopharmacology agents in development, but it was disappointing this year. Many of the posters were repeats of data presented in May 2006 at the American Psychiatric Association meeting in Toronto, Canada, and the lectures tended toward review sessions, providing little insight into drugs in development or issues that are impacting drug development. Even the FDA seminar was disappointing this year, with few messages worth reporting.

FDA Advisory Panel Recommends Approval of New Leukemia Drug -- Quick Pulse

Summary: The FDA took its Oncologic Drugs Advisory Committee (ODAC) on the road for the first time, holding a meeting in Atlanta in connection with the American Society of Clinical Oncology (ASCO) meeting to review Bristol-Myers Squibb’s Sprycel (dasatinib) in chronic myelogenous leukemia (CML). The panel voted overwhelming that the drug is safe and effective for patients both resistant to and intolerant of Novartis’s Gleevec (imatinib), the current standard of care for CML, and they agreed that it would be appropriate for accelerated approval.  

Cariovascular Revascularization Therapies (CRT)

Summary: U.S. cardiologists are not particularly concerned about late stent thrombosis, durable polymers, or the need for Sanofi- Aventis’ Plavix with drug-eluting stents, and they see little difference between Cypher and Taxus in those regards. ♦ Among doctors at CRT, use of Johnson & Johnson’s Cypher and Boston Scientific’s Taxus is fairly evenly split and likely to remain that way for the rest of this year. ♦ The FDA is taking a very cautious approach to PFO closure, and agency officials said bioabsorbable stents face formidable challenges. ♦ A company to watch: CardioMind.  

Continuous Glucose Monitoring Systems (CGMS) -- Quick Pulse

Summary: As a preview to the American Diabetes Association meeting in Atlanta June 9-15, 2006, endocrinologists and one RN were interviewed to determine how Continuous Glucose Monitoring Systems in general – and DexCom’s DexCom STS in particular – are being accepted by doctors and patients. The systems use glucose sensors implanted under the skin of the abdomen to provide a continuous reading. The sensor is about the size of an AA battery, and it transmits radio signals to a pager-sized receiver. Glucose levels are measured about every 30 seconds, and data are transmitted to the receiver every few minutes. Vibrations and auditory alarms go off when glucose levels are too high or too low.  

Digestive Disease Week (DDW)

Summary: Sucampo/Takeda’s lubiprostone has gotten off to a good start in chronic constipation, but the outlook is less certain in IBS-C, where Microbia’s linaclotide is early but looks promising. Neither appears to be much of a challenge to Adolor/GlaxoSmithKline’s alvimopan in opioid-induced constipation, but Progenics/ Wyeth’s methylnaltrexone could be, though it will first be subcutaneous. ♦ Use of biologic therapies for Crohn’s Disease − and ulcerative colitis − is poised to increase, and doctors expect Abbott’s Humira to capture the lion’s share of the market, though most won’t switch patients doing well on Johnson & Johnson’s Remicade. UCB Pharma’s Cimzia has the most convenient dosing (QM) but the least data, and it may have a harder time gaining traction. ♦ Salix’s Xifaxan is approved for travelers’ diarrhea but is getting widespread off-label use for all kinds of diarrhea. ♦ Doctors like the immediate-release pill formulation of Santaurus’ Zegerid much better than the powder, and usage is likely to increase but not dramatically. ♦ Use of Allergan/ Inamed’s Lap-Band for obesity is likely to remain flat to increase slightly in the U.S. and decline slightly in Europe. ♦ There is a fair amount of interest in Shire’s Mesavance for ulcerative colitis because reducing the pill burden is likely to increase compliance and, thus, response.