American Society of Clinical Oncology meeting
in Orlando - day 3

Further presentations at the American Society of Clinical Oncology meeting in Orlando were positive for Avastin from Genentech (NYSE: DNA) and Roche (Swiss: ROG) as well as Millennium's (NASDAQ: MLNM) proteasome inhibitor. Negative data will probably end development of Johnson & Johnson's (NYSE: JNJ) Zarnestra for pancreatic and colorectal cancer, although breast cancer, leukemia, and myelodysplastic syndrome investigations will continue. In a head-to-head study, Novartis's (NYSE: NVS) Femara outperformed AstraZeneca's (NYSE: AZN) Arimidex in breast cancer patients. A brief summary of the results is presented below, and full analysis will be presented in next Monday's Weekly Btech Report.

Avastin (bevacizumab, rhuMAb-VEGF, formerly anti-VEGF), a vascular endothelial growth factor-targeting monoclonal antibody, continued to generate evidence of therapeutic benefit in various solid tumors. The much-anticipated data were presented from a randomized, double-blind, placebo-controlled, phase II clinical trial designed to assess Avastin's treatment effect profile, as monotherapy, in patients with metastatic renal cell carcinoma (kidney cancer). The results demonstrated the efficacy that led to the early termination of the trial last October. Higher-dose Avastin recipients achieved a statistically significant increase in time-to-disease-progression. It took slightly more than two and a half times as much time for the cancer to measurably grow in Avastin recipients (approximately five versus two months). Also, a trial of 35 cancer patients with various forms of advanced cancer who had received Avastin monotherapy or Avastin plus chemotherapy for at least a year were assessed as a subset analysis from a series of phase I/II clinical trials. A significant proportion of Avastin recipients in this study have at least doubled their life expectancy.

The data from both trials suggest that more powerful, phase III, studies will achieve a significant magnitude of treatment effect advantage. Avastin' s adverse effect profile, the subject of many rumors based on leaked ASCO abstracts, appears to have remained predictable, manageable, and reassuring. Avastin is in phase III clinical trials for the treatment of various solid tumors, and data to date give it a greater than average probability for marketing approval.

Millennium's MLN341's phase II investigation update in patients with multiple myeloma whose disease has relapsed and not responded following multiple prior treatments continued to demonstrate the agent's quality treatment effect profile in the most extensively pretreated and refractory patients. Treatment benefit was seen in terms of stabilizing or reducing M protein, a primary marker of myeloma severity. More than three-quarters of the 78 initially treated patients did not show evidence of disease progression during a 24-week study. Overall median time to progressive disease was reassuring, while MLN341's adverse effect profile remained predictable, manageable, and reassuring.

MLN341 is a proteasome inhibitor. The proteasome, the cell's garbage processing plant, is a large protein complex that degrades other proteins. In cell and animal models, proteasome inhibition in cancer cells tends to halt cell division and induce apoptosis (cell suicide). Preclinical work demonstrates that cancer cells are more susceptible to proteasome inhibition than normal cells. Multiple myeloma is a particularly challenging form of cancer to treat successfully, and these data, if maintained over the full phase II study period and full cohort of 202 patients, more than qualify the agent to move through to phase III investigation where comparable achievements in more powerful study have a modestly higher than average probability of success.

Zarnestra (tipifarnib, R115777) failed to meet desired median overall survival endpoints in phase III clinical trials for the treatment of both locally advanced or metastatic pancreatic cancer and advanced, refractory colorectal cancer. Zarnestra is a farnesyl transferase inhibitor. In human clinical trials, responses to Zarnestra have been observed in breast cancer, relapsed or refractory acute leukemia, and myelodysplastic syndrome, and JNJ is continuing to pursue these indications.

Novartis's Femara (letrozole) outperformed AstraZeneca's Arimidex (anastrozole) in the battle of third generation aromatase inhibitors in the management of breast cancer. In the head-to-head study, 713 postmenopausal women with tumors positive (or unknown) for estrogen or progesterone receptors who had failed anti-estrogen therapy (e.g., tamoxifen) were treated with Femara or Arimidex. 50% more Femara recipients had at least a 50% reduction in the size of their advanced breast cancer tumors. Femara was also superior in terms of complete response rate, but was not able to demonstrate a significant advantage in terms of time to disease progression, the primary endpoint.

Aromatase inhibitors are likely to replace tamoxifen in the treatment of postmenopausal women with hormone-dependent breast cancer. Data suggest a place in the market for both Femara and Arimidex. Femara sales are currently growing at over twice the rate of Arimidex sales. However, Arimidex may gain momentum from expansion into adjuvant breast cancer therapy later this year.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
May 21, 2002

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BTECH NEWS, published by Btech Investor, Inc., highlights selected events in the life sciences sector that the Btech Investor team believes are particularly relevant to biotechnology investors. The Btech Investor team combines scientific, clinical, and business experience to perform comprehensive analysis of the biotechnology industry and to identify future industry leaders.

BTECH INVESTOR REPORTS

The Btech Investor Reports provide in-depth analysis of the biotechnology industry. Recent companies profiled include Vertex, EntreMed, Élan, IDEC Pharmaceuticals, Myriad Genetics, and Abgenix. Recent sector reports include nucleic acid therapeutics, Alzheimer disease, inhaled insulin, recombinant proteins, gene therapy, monoclonal antibodies, neurodegenerative diseases, stem cells, trends in oncology, genomics based drug discovery, and biotech trends.

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