May 2005 Issues

  American Association for Cancer Research

Summary: If there was any hot topic at this year's meeting of the American Association for Cancer Research (AACR), it was genomic signatures, which an AACR official estimated accounted for about 10% of the posters at the meeting. Small molecules, cancer stem cells, and therapies targeting smaller markets were highlighted. Doctors were also excited about the variety of VEGFR inhibitors, especially Genentech's Avastin (bevacizumab).

  Tercica's Increlex Growth Hormone - Quick Pulse

Summary: The FDA is reviewing Tercica's Increlex (mecasermin injection) for the long-term treatment of growth failure in children with a severe form of primary IGF-1 deficiency (Primary IGFD). Insulin-like Growth Factor (IGF-1) is the principal hormone necessary for statural growth (height). Primary IGFD is a disease characterized by lack of IGF-1 production in the presence of normal or elevated levels of endogenous growth hormone.

  American Pain Society

Summary: The head-to-head and sleep data on Ligand's Avinza may help with marketing, but doctors were underwhelmed. The pivotal trial of Cephalon's OraVescent fentanyl is expected to be completed by summer, with a 3Q05 filing. The launch of Pfizer's Lyrica (pregabalin) has been delayed while the DEA determines what Schedule it will get because of the euphoria side effect, and this is frustrating doctors. GlaxoSmithKline still has confidence in Lamictal (lamotrigine) for neuropathic pain and will repeat the two failed trials, but doctors are dubious they will be sufficient for approval. Pain doctors are interested in Johnson & Johnson's ionophoretic transdermal fentanyl for post-op pain, and they want to use it for outpatients as well as inpatients. Generic fentanyl matrix patches are not perceived to be as effective as J&J's Duragesic, but cost is driving usage. Interest in rechargeable spinal cord stimulators is growing, and they are expected to take ~30% market share.