December 2005 Issues

New Guidelines Issued for Peripheral Arterial Disease (PAD) -- Quick Pulse

Summary: The American College of Cardiology (ACC) and the American Heart Association (AHA) recently announced new national guidelines designed to standardize the management, detection, and treatment of PAD. The guidelines were developed not just for specialists who perfom the complex procedures used in the treatment of PAD, but also for primary care physicians, nurse practitioners, and physician assistants, all of whom make the initial diagnosis and initiate therapy. Carotid disease was not addressed because separate guidelines are being developed for that.

Merck's Infant Diarrhea and Shingles Vaccines get FDA Advisory Committee Recommendation -- Quick Pulse

Summary: Merck is pinning much of its future on vaccines, and an FDA panel recently moved two of the company's vaccines - RotaTeq for infant gastroenteritis and Zostavax for shingles prevention - a step closer to market. On December 14, 2005, the Vaccines and Related Biological Products Advisory Committee unanimously recommended approval of RotaTeq, and the next day the same panel voted that Zostavax is safe and effective but for a more limited age range than Merck had sought.

San Antonio Breast Cancer Symposium (SABCS)

Summary: Sources were very excited about Glaxo-SmithKline’s Tykerb (lapatinib) not only for Herceptin failures but also eventually in lieu of or combined with Herceptin. ♦ The E-2100 trial showed Genentech’s Avastin significantly improves progression-free survival in metastatic breast cancer, but doctors were not “wowed” with the data. ♦ Use of Genentech’s Herceptin is not increasing in the adjuvant setting – because doctors are already using it there, not because of cardiac toxicity concerns. The BCIRG-006 trial did not convince most U.S. doctors to stop prescribing Herceptin to Adriamycin patients, and a Finnish trial has not yet convinced doctors to shorten the duration of Herceptin treatment from 52 to 9 weeks. ♦ Use of American Pharmaceutical Partners’ Abraxane is increasing slowly, due to cost and side effects, particularly neurotoxicity. ♦ Use of gene array tests will not increase significantly until there is additional validation. ♦ Tomosynthesis may cause a paradigm shift in mammography within two to five years.

Medicare Coverage Advisory Committee (MCAC) Meeting on Age-related Macular Degeneration (AMD) -- Quick Pulse

Summary: The MCAC meeting seemed to be focused on how to design better trials of treatments for AMD, the leading cause of blindness in people 65 years old or older, with an estimated 165,000 new cases each year. However, it was obvious early on that panel members were confused about many things, including definitions, experimental treatments, and even the questions posed to the panel.

American College of Rheumatology (ACR)

Summary: Genentech/Biogen Idec/Roche's Rituxan stole the show with impressive results in rheumatoid arthritis (RA) - including some early radographic data - that had rheumatologists eager to use it. In fact, many have already started using it off-label in lupus and a few refractory RA patients.♦ Bristol-Myers Squibb's Orencia also was generating excitement, but doctors do not know how to choose between Orencia and Rituxan for TNF failures. ♦ Johnson & Johnon/Scherling-Plough's golimumab (CNTO-148) appears, from Phase II data, to be on track to replace Remicade in RA. ♦ Roche's Actemra (tocilizumab) looks like another option for RA, but liver and lipid elevations are casting a shadow over the prospects for this agent. ♦ Amgen's denosumab was shown to be effective at increasing bone density in postmenopausal women, and Jazz Pharmaceuticals/Orphan Medical's Xyrem was shown to be efficacious for fibromyalgia, but Neurochem's Fibrillex had disappointing results in amyloidosis.

American Society of Nephrology (ASN)

Summary: Several new agents look promising to treat anemia, including Affymax's Hematide, Roche's CERA, and FibroGens's FG-2216 and FG-4592.♦ Nabi Biophamaceuticals may abandon StaphVax, but Keryx is not giving up on sulodexide in diabetic nephropathy. ♦ Abbot's oral Zemplar isn't generating any excitement and usage is increasing very slowly. ♦ Amgen's Sensipar is catching on, but it is having less effect on use of vitamin D or Genzyme's Renagel than was predicted. ♦ The DCOR Renagel mortality study didn't impress most experts, but it may be a useful marketing tool. ♦ Also worth watching: FibroGen's FG-3019 (CTGF) for renal fibrosis, and Speedel's SPP-301 for diabetic nephropathy. ♦ Nephrologists were not concerned with new CMS anemia drug reimbursement regulations.