Biotechnology Healthcare - July/August 2008 - (Page 32)

LATE-STAGE RA THERAPIES The Next Generation: The first RA biologics were a godsend for many people who got no relief from traditional therapies. But RA’s pathogenesis is elusive, so unmet needs remain; ‘We’ve got a Ford, and we’re putting the mirrors in different places,’ says one researcher about treatment approaches. Until science unlocks the secrets of RA, promising new therapies may at least offer more horsepower to patients in need. BY JOHN CARROLL Senior Contributing Editor I n his work as chairman of medicine at New Jersey’s Newark Beth Israel Medical Center, Robert G. Lahita, MD, PhD, has seen the number of therapeutic options for rheumatoid arthritis expand steadily over the years. Tumor necrosis factor (TNF-α) inhibitors, like etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade), have made a big difference to patients by controlling their pain and swelling, and the inflammation that can debilitate their joints. But even this author, researcher, and physician — who treats 200 RA patients a year — still can be blindsided in his attempts to treat a chronic condition that never has been fully understood. “We don’t really know much about the disease itself,” says Lahita. “We don’t know the cause of RA. Right now, we’re on a plateau. We’ve got a Ford, and we’re putting the mirrors in different places, but we’re not attacking the disease directly.” In one extremely rare case, a patient’s skin lost pigmentation after he began treatment. “Basically, he was bleached,” says Lahita, who wrote Women and Autoimmune Disease: The Mysterious Ways Your Body Betrays Itself. “I’ve never seen that in anybody. The drug company says they’ve seen it once. But these drugs have side effects. Everything we take is a trade off.” Drawn by a fast-growing, multibillion-dollar market, drug developers are promising to deliver new therapies that can be even easier to administer, although they are still a long way from a cure. The wave of late-stage candidates includes certolizumab (Cimzia) and golimumab, both angling for near-term U.S. Food and Drug Administration approval in the hope of joining the group of anti-TNF-α therapies already on the market. Tocilizumab (Actemra) is looming as well, in a new non-TNF-α category. The combination of new RA biologics on the market and pending approval of even more RA drugs has made this a fast-growing segment of the drug spend. Research and Markets estimates that total sales of RA drugs hit $11.6 billion in 2007, and is expected to mushroom to $27 billion by 2015. “The number of patients is growing,” says Cindy Mundy, PhD, an analyst and director of immune and inflammatory disorders at Decision Resources, a research company in Boston, “largely because of patient demographics. It is a disease that affects people as they grow older; the penetration of very high-priced drugs also is driving the market” as physicians get more aggressive in treating the disease at an earlier stage of development. “Research into new treatments is intense,” according to a recent Research and Markets report, “driven by the need for safer and even more effective medications with more convenient dosing schedules. GlaxoSmithKline, Johnson & Johnson, Roche, Schering-Plough, and UCB all have biologics in late phases of development, while Pfizer is pinning its hopes on its oral kinase inhibitors [now in phase 2 development]. As these new therapies come on board and the market becomes more competitive, the prospects for RA patients can only improve.” POTENTIAL BLOCKBUSTERS Decision Resources tapped one promising new RA drug, tocilizumab, as a potential blockbuster, with expectations of more than $1 billion a year in sales. Unlike TNFα inhibitors, tocilizumab works by 32 BIOTECHNOLOGY HEALTHCARE · JULY/AUGUST 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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