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JUNE 2, 2005
Biotech, Finally It has been 30 years of promising research and crushing commercial disappointments. Now a burst of breakthroughs may be the tipping point Ulia Barchitta's main physical complaint these days is blisters on her feet. That's pretty remarkable, considering she has been living for three years with metastatic kidney cancer -- a notoriously hard-to-treat disease. Until May, 2004, the 61-year-old dean of the Center for Career Development & Experiential Learning at Wagner College in New York was lucky enough to respond to interferon, a drug that works for only 10% to 20% of patients. But she grew resistant, and the tumors spread throughout her body. Barchitta knew how tough it can be to beat cancer. Shortly after her own tumor was discovered, her husband was diagnosed with lung cancer and died four months later. So in June, 2004, Barchitta agreed to enter a clinical trial at Memorial Sloan-Kettering Cancer Center for an experimental therapy named Sutent, one of a new class of multitargeted cancer drugs. Sutent was originally discovered by Sugen Inc., an innovative biotech firm that was absorbed into giant Pfizer (PFE ) in 2002. CHANGING PROGNOSES. Barchitta had no hesitation about serving as a guinea pig. "Let's face it, the statistics are not great for kidney cancer," she says. "What did I have to lose?" In fact, she is one of the winners: Sutent eliminated all traces of Barchitta's cancer, and it has yet to recur. The only side effect has been those blisters. "I've learned to wear sneakers to work," she says. Stories like barchitta's have convinced many doctors that medical care is reaching a tipping point. Not that most patients will be healed right away -- the vast majority of sick people continue to dose themselves with tiny bits of chemicals, otherwise known as pills, that represent medicine's Old Guard. But the times are changing. The past 30 years of biological discoveries, insights into the human genome, and exotic chemical manipulation have unleashed a wave of biological drugs, many of them reengineered human proteins. These molecules have the power to change the prognoses for a huge range of diseases all but untreatable just five years ago. "GOLDEN AGE." Recent weeks, for example, have seen announcements of startling advances against cancer and age-related blindness, diseases with miserable outlooks before. Cancer patients in particular have reaped rewards from biotech. A decade ago there were fewer than 10 oncology drugs in clinical trials, most of them highly toxic chemotherapies. Today over 400 cancer drugs are being tested in humans, and almost all are targeted biotech medicines designed to produce minimal side effects. Biotechnology has finally come of age. This declaration may bring to mind the hype that has swirled around biotech so many times in the past. But a growing number of scientists and industry executives say today's enthusiasm is based on a new reality: Drugs actually exist. There are 230 medicines and related products created from biotech techniques. Last year alone, the Food & Drug Administration approved 20 biotech drugs, among them treatments for insomnia, multiple sclerosis, severe pain, chronic kidney disease, incontinence, mouth sores, and cancer. The Tufts Center for the Study of Drug Development estimates that at least 50 of 250 biotech drugs currently in late-stage clinical trials should win FDA approval, a success rate almost three times better than the pharma industry standard. "This is all a continuum of discoveries that started in the early 1980s," says Joseph Schlessinger, chairman of the pharmacology department at Yale School of Medicine and a co-founder of Sugen, the company that created Sutent. "We are now in a golden age of drug discovery." TESTING IDEAS FASTER. Even long-beleaguered biotech investors have reason to be optimistic. True, biotechnology indexes have underperformed the overall market for much of the past year, and few of the 1,500 companies in this sector are profitable (see BW Online, 6/2/05, "Why Biotech Stocks Are Sedated"). But the medicines are selling. Ernst & Young International estimates that nine new biotech drugs approved in 2004 will bring in total revenues of $3 billion this year. By 2007, sales of just those products should grow to $8 billion. "I would say the industry as a group will become profitable by 2008," says Dr. Mark Monane, director of biotech research at investment advisers Needham & Co. The industry is also building on its own success, applying lessons and testing out ideas faster than ever. Sutent is widely expected to win FDA approval by early next year for stomach cancer patients who have grown resistant to Gleevec, a breakthrough cancer drug that itself reached the market only four years ago. Last December the FDA approved Macugen, from Eyetech Pharmaceuticals, as a first-in-class treatment for macular degeneration, the leading cause of age-related blindness. By next year the agency will likely consider a Genentech (DNA ) drug, Lucentis, that appears to be even more effective. DEBT TO ACADEMIC RESEARCHERS. There are even glimmers that the long-awaited age of personalized medicine may not be far off. Biotech companies have been skilled at coming up with innovative new drugs -- but not so good at figuring out whom they are most likely to help. Response rates for cancer drugs, for example, often are stuck at 20%. Tired of such poor performance, pharmaceutical companies are focusing more effort on developing the diagnostic tests that would match a treatment to a patient's genetic profile, reducing side effects and increasing efficacy. "I think you are going to see a revolution in personalized medicine in just a few years," predicts Dr. George Demitri of Dana-Farber Cancer Institute in Boston. This biotech-driven medical revolution is actually an evolution: It evinces the slow accumulation of decades of research. Since 1973, when genes that produce useful human proteins were first mass-produced in cell cultures, a vast number of scientists have pursued the same dream -- to create new molecules, via gene manipulation or gene targeting, that would change the course of human disease. "What's interesting is that it is really the academic researchers that pushed biotech forward, not corporate research and development," says Allan B. Haberman, principal of pharmaceutical consulting firm Haberman Associates in Wayland, Mass. SHYING AWAY. Academic researchers, unlike traditional drug companies, were willing to champion biotech approaches to drugs even when they were long shots. ImClone Systems' (IMCL ) Erbitux, a colon-cancer treatment approved last year, would not exist today if not for the efforts of its discoverer, Dr. John Mendelsohn. The scientist-clinician spent 20 years working to find a company willing to commercialize his discovery that some tumors could be stopped by blocking a certain growth enzyme. Even Gleevec, the most effective cancer drug of the past decade, was almost abandoned by Novartis (NVS ). An outside cancer specialist, Dr. Brian J. Druker of Oregon Health & Science University, coaxed the company into pursuing its development. Traditional pharmaceutical companies shied away from biotech for years, unwilling to bet on unproven technologies. It didn't help that biotech's earliest accomplishments met with setback after setback in the 1980s and '90s. BLOCKBUSTER MYOPIA. Today, Big Pharma is paying for its risk-averse stance: Major players have few promising products in their development pipelines, and most are stuck with a business model heavily dependent on blockbuster drugs. Boston Consulting Group estimates that, as a result, biotech firms produced 67% of the drugs in clinical trials last year but shouldered only about 3% of the $40 billion that the drug industry spent on R&D. "Focus on unmet needs" has long been the mantra of the biotech industry. Most of those drugs do just that. The strategy has paid off for Genentech, whose market capitalization is larger than Merck & Co.'s (MRK ) -- the nation's third-largest pharmaceutical company -- thanks in part to a roster of cancer drugs that have become surprise billion-dollar sellers. "Focusing on blockbusters to the exclusion of other things can introduce a level of myopia," says Genentech CEO Arthur D. Levinson. "So often the estimates of potential are wrong."
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