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JUNE 2, 2005
Biotech, Finally [Page 2 of 3] MIMICKING BIOTECHS. Big Pharma is now eager to join the game. It is partnering with biotech firms, buying them outright, or trying to emulate their success by overhauling their own R&D efforts. Novartis moved its worldwide research organization from Switzerland to Cambridge, Mass., two years ago, in hopes that it will behave like a freewheeling biotech. It also recruited an academic researcher, Dr. Mark Fishman of Harvard Medical School, to run the place. Efforts by the pharmaceutical industry to mimic biotech -- or merge with it -- should quicken the pace of medical innovation. Here are three treatment and research areas poised to benefit: Cancer In no other therapeutic area has biotech made as big a difference as it has in oncology. New drugs that target tumor cells while only minimally damaging healthy tissue have led to a paradigm shift in cancer treatment. Doctors now talk about the disease as a chronic, treatable condition. In 2004 alone, four targeted cancer drugs -- Avastin, Tarceva, Iressa, and Erbitux -- won FDA approval. Avastin, from Genentech, has extended the life spans of lung, breast, and colon cancer patients, a first for any oncology drug. To the public, though, the picture still looks dismal. Three decades after President Richard M. Nixon declared war on cancer, the disease is the largest killer for people under 85, causing one in four U.S. deaths each year. "There is now a vital pipeline of targeted therapeutics," says Dr. Roy S. Herbst, a lung cancer specialist at University of Texas M.D. Anderson Cancer Center. "But we have to be realistic. This is not a cure. It's a place to start." Many biotech researchers feel they are well out of the starting gate with a huge variety of emerging cancer treatments. Unlike heart disease, where patients choose between seven nearly identical cholesterol-lowering statins, targeted cancer therapies come in many forms. There are drugs that block tumor-growth factors, starve the tumor by inhibiting blood-vessel growth, combine radioactive isotopes with tumor-seeking proteins, and use vaccines to train the body's immune system to attack cancer cells. ATTACKING TOUGHEST CANCERS. There is even a next wave of multitargeted drugs that could start winning FDA approval as early as next year. Sutent, the drug keeping Julia Barchitta alive, is a member of this emerging class, known as multi-kinase inhibitors. They block blood-circulating proteins that are responsible for both tumor growth and blood vessel creation. Other closely watched candidates in this class include sorafenib, developed by Bayer (BAY ) and Onyx Pharmaceuticals (ONXX ) for kidney cancer, and lapatinib, a breast cancer drug from GlaxoSmithKline (GSK ). These multitargeted therapies seem particularly effective against the hardest to treat cancers, giving hope to some of the sickest patients. A prime example is an Eli Lilly (LLY ) pill, enzastaurin, for recurrent glioblastoma, the most aggressive form of brain cancer. "It's a desperate disease for which there are very few adequate treatments," says Dr. Howard A. Fine of the National Cancer Institute. GIVING HOPE. Enzastaurin blocks two pathways vital to tumor growth and shuts off blood vessels that feed the tumor. In a trial conducted by Dr. Fine, enzastaurin shrank tumors in 25% of 92 patients, an unusually robust response for this disease. Tumor shrinkage is not tumor elimination, of course. But cancer specialists are hopeful that, as more targeted therapies come on line, they can be combined into cocktails that will keep cancer patients alive for years. Renowned cancer researcher Dr. M. Judah Folkman of Children's Hospital in Boston says the most important thing is that the drugs give patients hope: "We have something to offer [patients] now, and if it keeps them alive a little longer, something else might come along." Diagnostics The biggest problem with most major drugs today is that they don't work in anywhere from 25% to 60% of patients. Biotech is starting to improve that ratio. In January the first DNA-based test was launched that can predict an individual's response to a wide range of drugs. Developed by Roche Pharmaceuticals (RHHVF ) and Affymetrix (AFFX ) in Santa Clara, Calif., the thumbnail-size device, called the AmpliChip CYP450, detects about 30 variations in two genes that regulate how the liver metabolizes such commonly prescribed medications as antidepressants, beta blockers, and pain relievers. A single drop of blood allows the chip to identify which patients clear a drug too quickly for it to do any good and which clear it too slowly, leaving them vulnerable to side effects. Roche, a leader in diagnostics, hopes to have a similar DNA chip on the market by yearend that can identify any of 25 different subtypes of leukemia, as well as a chip that can pick up the p53 gene, a tumor suppressor that often mutates in patients with cancer. These tests will help doctors figure out the best treatment. "We will be able to diagnose things probably earlier than we will be able to treat them," says Roche CEO Franz B. Humer. DISINTEREST IN TESTS. That wouldn't be such a terrible problem. Patients and doctors alike are eagerly waiting for biotech to deliver treatments tailored to an individual's genetic makeup. But diagnostics have long lagged behind drug development, in part because the biology of disease was so poorly understood. "In the past, medicine has been reactionary. We wait for people to get sick, then we treat the disease," says Peter D. Meldrum, CEO of Myriad Genetics (MYGN ). "The majority of drugs on the market treat only symptoms, not causes." Pharmaceutical companies also were never much interested in developing diagnostic tests: They wanted their drugs to be taken by as many patients as possible to ensure maximum revenues. But the dire side effects that pushed Merck's Vioxx pain reliever off the market underscore the grave dangers of such an approach. ECONOMIC DRIVER. Biotech pioneer Genentech took a different tack when it introduced its breast cancer drug Herceptin in 1998. It was the first cancer drug to be marketed simultaneously with a genetic test that could pinpoint the 25% to 30% of breast cancer victims in which Herceptin would work. The drug has gone on to be a hugely successful. Now Abbott Laboratories is readying similar tests that can identify patients most responsive to Iressa and Erbitux, cancer drugs that are effective in only 10% and 25% of patients, respectively. Biotech researchers believe larger numbers of patients will be helped when scientists identify more genetic or protein variations, known as biomarkers, linked to specific diseases. A number of companies and researchers are developing tests that can predict who is most susceptible to a given disease, allowing for preemptive action. Myriad Genetics has four diagnostic tests on the market that spot genetic susceptibilities to breast cancer, colon cancer, and melanoma. These tests are not just telling patients that it's time to prepare their wills. If a woman learns she is at high risk of developing breast cancer, for instance, there are drugs she can start taking that lower the probability. Economics is driving the development of these tests as much as medical need. Biotech cancer treatments can cost $20,000 to $40,000 per month. Giving them to a broad patient population, most of whom won't respond, "is a huge public-policy train wreck," says Patrick F. Terry, co-founder of the Personalized Medicine Coalition. This group of companies, public agencies, academic scientists, and patient groups is encouraging a collaborative search for biomarkers that will prevent such a crash. "The cost savings will be highly self-evident," he says.
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