|
|
ONLINE FEATURES
Book Reviews
BW Video
Columnists
Interactive Gallery
Newsletters
Past Covers
Philanthropy
Podcasts
Special Reports
BLOGS
Auto Beat
Bangalore Tigers
Blogspotting
Brand New Day
Byte of the Apple
Economics Unbound
Eye on Asia
Fine On Media
Green Biz
Hot Property
Investing Insights
Management IQ
NEXT: Innovation
NussbaumOnDesign
Tech Beat
Working Parents
TECHNOLOGY
J.D. Power Ratings
Product Reviews
Tech Stats
Wildstrom: Tech Maven
AUTOS
Home Page
Auto Reviews
Classic Cars
Car Care & Safety
Hybrids
INNOVATION
& DESIGN Home Page Architecture Brand Equity Auto Design Game Room SMALLBIZ Smart Answers Success Stories Today's Tip INVESTING Investing: Europe Annual Reports BW 50 S&P Picks & Pans Stock Screeners Free S&P Stock Report SCOREBOARDS Hot Growth 100 Mutual Funds Info Tech 100 S&P 500 B-SCHOOLS Undergrad Programs MBA Blogs MBA Profiles MBA Rankings Who's Hiring Grads | |
MAY 5, 2004
By Amy Tsao A Cancer Drug Under a Cloud Several troubling but inconclusive studies suggest that EPO, a huge earner for Amgen and J&J, might actually lower survival rates For the last decade, many cancer patients undergoing chemotherapy have considered erythropoietin (EPO) a godsend. While the highly toxic chemo treatments kill cancer cells, they also weakens the rest of the body. That's where biotech drug EPO comes in. It boosts red-blood-cell levels and alleviates the anemia that comes from chemotherapy. The resulting difference in patients' sense of well-being has made EPO a smash hit for the companies that make and market it -- Amgen (AMGN ) and Johnson & Johnson (JNJ ). "In treating anemia, this drug has had major impact on quality of life," says Dr. Stephen Nimer, head of hematologic oncology at Memorial Sloan-Kettering Cancer Center in New York City. "That should not be minimized." SPOTLIGHT ON CONCERNS. However, EPO's benefits for cancer patients have come into question. Until recently, the drug has "been considered beyond reproach," notes Geoff Porges, biotech analyst at Bernstein Research. But recent data are showing that patients who take EPO may have more blood clots and other serious cardiovascular problems than those not taking it. Even more disconcerting, in some studies, anemic cancer patients on EPO appear to survive for shorter periods than those not given it. A Food & Drug Administration advisory committee meeting on May 4 put a spotlight on the concerns over EPO and how Amgen and J&J should proceed. The agency has asked the drugmakers to conduct additional studies. Wall Street is speculating that both pharmas will spend substantial time and money to carry out the tests, and the market for the drugs could suffer if physicians become more cautious in EPO's use. EPO is big business. Amgen and J&J pulled in $3.9 billion apiece in 2003 sales of the drug. Analysts predict the impact on Amgen, which derives close to half of its total $8.4 billion in revenues from EPO products Epogen and Aranesp, may be particularly jolting. "The [safety] questions and associated challenges to reimbursement reinforce our concerns about the medium-term growth prospects for Amgen's core growth driver, Aranesp," Porges wrote in a May 3 research note. The need to clarify safety issues puts EPO's growth in doubt at both companies, says Craig West, an analyst at A.G. Edwards. NURTURING TUMORS? Experiments have shown that EPO appears to be doing several things at once -- some good, some bad. It primarily stimulates red-blood-cell growth, but it also helps angiogenesis, the process by which tumors are nourished, by stimulating vascular endothelial growth factor (VEGF), a key player in angiogenesis. Blocking VEGF and its variations is the goal of many so-called targeted cancer therapies, including Genentech's (DNA ) recently approved Avastin for colorectal cancer. Animal and lab studies also show that many cancer cells have receptors -- think of them as little docking stations -- for EPO. Researchers suspect that when EPO is injected, its molecules attach themselves to the receptors on cancer cells, where they may help spur tumor growth. Most compelling, the FDA advisory committee notes, are cases in which antibodies to EPO were introduced. The antibodies appear to cause tumor destruction or slow tumor growth. The evidence of shorter survival times isn't concrete, since trials in which patients were found to not live as long on EPO vs. placebo weren't specifically intended to measure survival. The companies have agreed to the FDA's request for more trials and are fully cooperating, although they dispute evidence that EPO is the cause of lower survival rates. UNEXPECTED MORTALITY. "At present, no evidence suggests that Aranesp is associated with impaired survival in patients with cancer," Amgen said in documents provided for the May 4 meeting. J&J also makes the same claim for its EPO drugs. However, the FDA advisory committee points to at least two placebo-controlled clinical trials performed that resulted in shorter survival times. A study in Europe of J&J's EPO drug Eprex unexpectedly resulted in a higher mortality rate in those who received it. During an interim analysis in April, 2002, of 938 patients in the trial, there were 170 deaths -- 101 in Eprex-treated patients and 78 in the placebo group. A European monitoring committee discontinued the study before its planned completion, but the available data showed that twice as many patients on the drug saw their cancer worsen, vs. participants receiving the placebo. And among 57 patients who died within the first four months of the study, 41 were in the Eprex group, and 16 were on the placebo. Another controlled study, involving head- and neck-cancer patients undergoing radiation treatment to test whether EPO would help sensitize patients' tumors to radiation, produced a similarly alarming result on survival. The study of 351, published in The Lancet in October, 2003, found that those given a placebo had an estimated median survival time of 928 days, vs. 605 days in those who got the drug. The authors, based in Germany, concluded that treatment with EPO "is associated with unfavorable outcome." BENEFITS VS. RISKS. EPO's importance in making cancer patients feel better can't be underestimated. "Given what we know, there's reason to believe that benefits still outweigh the risk," says A.G. Edwards' West. Sloan-Kettering's Nimer agrees, adding that the FDA is also right to ask for trials looking specifically at survival in patients with cancer-related anemia. "If EPO is impacting survival times, a doctor would want to present other options to patients," Nimer says. "At the moment, in absence of data each doctor would probably individualize his approach to patients." Still, yellow flags are definitely up. Over the next several years, more studies designed to measure survival rates and the effect of the drug on tumors will go a long way to answer these pressing questions.  Tsao covers biotechnology issues for BusinessWeek Online. Follow her Biotech Beat column only on BusinessWeek Online Edited by Patricia O'Connell
BW MALL
SPONSORED LINKS
Buy a link now!Get BusinessWeek directly on your desktop with our RSS feeds.  Add BusinessWeek news to your Web site with our headline feed. Click to buy an e-print or reprint of a BusinessWeek or BusinessWeek Online story or video. To subscribe online to BusinessWeek magazine, please click here. Learn more, go to the BusinessWeekOnline home page  | | |
 Copyright 2004, by The McGraw-Hill Companies Inc. All rights reserved.Terms of Use | Privacy Notice |
Printer-Friendly Version
