CMS Announces U.S. Healthcare Spending Slows for the First Time in Seven Years - Quick Pulse

Summary: The pace of health spending growth slowed in 2003, marking the first deceleration in national health spending growth in seven years, according to a report by CMS actuaries. This article summarizes the key findings in this report.

  Results of Novartis's Femara BIG-1-98 Trial - Quick Pulse

Summary: The results from the BIG-1-98 trial of Novartis’s Femara (letrozole) vs. tamoxifen in breast cancer were presented at the St. Gallen Primary Therapy of Early Breast Cancer conference on January 26, 2005. This is a quick look at those results.

  Inspire Pharmaceuticals' Diquafosol for Dry Eye - Quick Pulse

Summary: In December 2003, Inspire received an approvable letter from the FDA for diquafosol (INS365), and the company announced that it had to do another trial to gain approval. That trial, Study 109, got underway in June 2004, and the results could be reported any day. This report looks at the issues facing diquafosol and the outlook for approval.

  San Antonio Breast Cancer Symposium

Summary: Use of aromatase inhibitors is increasing, but doctors do not anticipate any significant market share shifts among the three approved AIs. The preference appears to be: AstraZeneca’s Arimidex for newly diagnosed breast cancer patients; Pfizer’s Aromasin for patients switching from tamoxifen to an AI after 2-3 years; and Novartis’s Femara for patients who have taken tamoxifen for five years. Doctors are excited about American Pharmaceutical Partners’ nanoparticle paclitaxel (abraxane). They believe the FDA will approve it, and usage is likely to ramp quickly, especially for metastatic breast cancer, provided the cost doesn’t make insurers balk on coverage. Assays to determine response to tamoxifen and chemotherapy are starting to catch on, and Genomic Health’s Oncotype DX has the lead. Doctors are poised to start using this test now that validation studies have been done. Doctors are interested in Immunicon’s less expensive circulating tumor cell test (CellSearch), to be marketed by Johnson & Johnson/Veridex as well as Quest Diagnostics, but it is catching on slower.

  Renal Research Institute's 7th International Conference on Dialysis

Summary: Surprisingly, Shire was not at this meeting and not promoting its new phosphate binder, Fosrenol. Nephrologists do not believe their use of EPO will be affected by Medicare reimbursement cuts. Use of Amgen’s Sensipar is growing, with no effect on Genzyme’s Renagel or vitamin D, but doctors expect to cut vitamin D use by as much as half in the future. FibroGen’s FG-2216, an oral erythropoiesis stimulator which is starting Phase II trials, generated some buzz. There was no excitement about Keryx’s sulodexide, but it looks promising for treating diabetic neuropathy. Davita’s purchase of Gambro is viewed positively; Davita is considered much better run than Gambro, and the joint company will have more bargaining power, but the challenge will be meshing two very different cultures. Use is increasing of Bone Care International’s IV and oral Hectoral, but Abbott may stop or reverse any share loss when it gets approval for oral Zemplar.

  American Heart Association

Summary: Numerous studies presented at the American Heart Association (AHA) meeting were described as likely to change practice over the next year, including the PEACE trial, Vitamin E, REACT trial, SCD-HeFT, Acorn’s CorCap CSD. Other topics considered still too far away to have an impact yet but which are likely to be very important in the future included A-HeFT results on NitroMed’s BiDil and Sanofi-Aventis’s Acomplia. These and many more topics are covered in this comprehensive report on the AHA meeting.

  American Society of Hematology

Summary: Bristol-Myers Squibb’s BMS-354825 and Pfizer’s SU-11248 continue to look promising to treat Gleevec failures in CML, and they may eventually replace Gleevec front-line, but BMS- 354825 increases QTc slightly, which is being monitored in the Phase II trial. However, there is a new player on the block: Novartis’s AMN- 107, which may give the other two a run-for-the money. Biocryst’s forodesine (BCX-1777) looks very promising in CTCL, but the outlook in T-cell ALL – which is the more important market and the indication in which it will be filed – is less certain. The data on Celgene’s Revlimid was hard to get but looked good, and sources believe it is approvable, but the trial deaths bear watching, and the MDS market may be somewhat more limited than expected. Interest in Pharmion’s Vidaza is growing, and SuperGen’s Dacogen has several hurdles to overcome. Development appears to be continuing for Merck’s SAHA, an HDAC. Hematologists/oncologists are not happy with new CMS reimbursements for chemotherapy, but the sky does not appear to be falling in – yet.