Biotechnology Healthcare - July/August 2008 - (Page 35)

“After that,” Mundy sums up, “the pipeline is a little less sure. You have agents targeting IL-1. Then there’s Kineret, Amgen’s other biologic for RA. That’s really how the pipeline is shaping up.” In a recent report on the RA market, Mundy ruled out any of the new therapies from competing with etanercept’s reputation as the reigning therapeutic gold standard. “While emerging therapies such as golimumab and Cimzia offer superior delivery to that of Enbrel due to improved dosing frequencies, these agents’ overall efficacy, safety, and tolerability are inferior to those of Enbrel — and efficacy, safety, and tolerability are weighted more heavily by rheumatologists as key drivers of prescribing decisions,” said Mundy. “As a result, the improvements in dosing frequency that golimumab and Cimzia offer over Enbrel are not sufficient to propel either agent to the position of future gold standard.” EARLY-STAGE STUDIES Look a little deeper into the pipeline, though, and you’ll find a group of biotech companies with earlier-stage therapies for RA. Their emphasis is to advance ease-ofadministration to an even higher level and keep posting strong efficacy data — all while searching for an even better safety profile. Researchers for Rigel Pharmaceuticals, for example, announced in late December that tamatinib (R788), an oral syk kinase inhibitor, had a statistically significant effect in interrupting hypercellular signaling that triggers inflammation. Rigel touted the drug’s ACR scores on symptom relief, noted that it was well tolerated, and offered that as an oral drug, R788 could be an improvement over current therapies. At Trubion, researchers are taking the CD20 approach one step further, relying on a small modular immunopharmaceutical that’s about a third of the size of antibodies and has a long duration of action. “TRU-015 targets the CD20 antigen of the cell surface of B cells, the same as Rituxan,” says Trubion CEO Peter Thompson, MD. But the way TRU-015 works should allow for its administration every six months — a major leap ahead in ease of adminstration. “The physical properties of a smaller-particle-sized drug versus a larger-particle-sized one favors the former,” Thompson says. “Diffusion is determined by particle size; the bigger the particle, the slower it moves out of the blood stream.” Because RA patients are likely to see their physician every quarter, the doses can be administered during one of those regular visits. “Giving it on day 1 and then every six months allows for interim B-cell recovery,” says Thompson. “That can be accomplished with patients in high-responder categories. It can maintain superior convenience coupled with a better safety profile and demonstrated efficacy. That could be the profile for a category leader.” It’s not easy finding RA patients for a trial these days. As developers advance new therapies, they all have to vie for volunteers. “It’s very competitive,” Thompson agrees. Dosing schedules aside, Mundy thinks delivery-device improvements also would be notable. “I have heard anecdotally that some physicians note the pen causes injection-site pain,” says Mundy. Another device that causes less pain and offers comparable efficacy — and allows people to become more active while lessening the signs of disease progression — would have a distinct advantage on the market.” THE PRICING CONUNDRUM One thing you don’t hear a lot about right now from the biotech companies is some idea of pricing. “We do not discuss any pricing at this point in time,” notes Antje Witte, a spokesperson for UCB in Belgium. But the analysts see an opportunity for some savings. “Cimzia and golimumab are test cases for the pricing environment for biologics in a larger sense,” says Mundy. “There, you might see modest discounts. You don’t see many classes where a competitive landscape could drive prices down. Humira was the third TNF-α inhibitor, with some delivery advantages, and that still earns a premium over Remicade and Enbrel in a lot of markets. Actemra, the only agent in its class, would likely get a premium price.” The market looks promising, but Lahita counsels patience above all. “Until the final set of data is in on Cimzia and IL-6, no one knows what will happen,” says Lahita. “My feeling is that we’re not getting at the heart of the pathogenesis of the disease. We’re getting rid of cytokines. The more we understand about the pathogenesis and basic molecular errors, the more we will be able to directly attack the disease process rather than cytokines. As we inhibit cytokines, there are bound to be side effects, because we’re blocking cellto-cell communication. A more honed therapy is needed.” That, he says, will require a whole new make and model to replace today’s Fords. Senior contributing editor John Carroll is a freelance writer and is the editor of Fierce Biotech. JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 35

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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