Biotechnology Healthcare - July/August 2008 - (Page 34)

Prescribing decisions are based more on efficacy, safety, and tolerability than on dosing frequencies, says Cindy Mundy, PhD, at Decision Resources. Lancet. But his excitement, he noted, was tempered by the lack of comparative effectiveness and safety data between these new therapies and those already on the market. Analysts, though, see the upsides. “Patients have to fail one or two TNF-α inhibitors before moving to an alternative mechanism of action,” notes Mundy, at Decision Resources. “Actemra has been gaining steam in recent months, with more and more trial data. Thought leaders with experience in seeing those patients who have received treatment have a very favorable opinion of the drug. In terms of efficacy, it could be a leader among non-TNF-α drugs, competing with Orencia and Rituxan. That’s a pretty sizable market opportunity.” “The IL-6 inhibitor is exciting,” says Lahita. “Originally, I would have thought IL-6 would have been useful in lupus. Now it’s being developed for RA, because the market is so huge, rather than what you see for orphan diseases.” But the new option that Lahita could turn to most often may be certolizumab — a PEGylated therapy that prolongs the therapeutic activity of the active ingredient by wrapping strands of polymers on a molecule. Certolizumab, now approved for Crohn’s disease, has been tested successfully in several late-stage trials with dosing either every two or four weeks. In February, UCB filed a biologics license application for FDA approval for treatment of RA. “Cimzia will be very interesting,” says Lahita. “Dosing is once a month, subcutaneously, making it very easy for patients who inject it. I will switch a lot of patients to that. We’re trying to get away from having patients sit in a chair for four hours (for an infusion). A PEGylated form that could be given once a month subcutaneously would be a boon.” But the therapy’s advantage also raises a troubling fear. “The only problem is its once-amonth dosing schedule,” says Lahita, who has been engaged in a number of drug trials over the years. “The antibody will be around for a while, constantly affecting the TNF[-α]. Delivery is always an issue with these drugs. If you get a side effect like roaring tuberculosis, then you have a problem. You want to stop treating the patient. But, if [the antibody is] going to be around for a month, and a patient develops side effects, it’s hard to stop.” Ease of administration is a key collective benefit of the new slate of RA therapies, says Mundy. Both certolizumab and golimumab have the same TNF-α mechanism as the three TNF-α inhibitors already on the market. “The thought leaders say you can see subtle differences,” she adds, “but, overall, they’re similar. It’s hard to pick a front runner.” PENS: MARKET MAKERS Up until the latest raft of RA biologics hit the market, doctors had relied heavily on methotrexate, a DMARD that Mundy calls “the workhorse of disease-modifying therapies.” Physicians also have routinely used nonsteroidal antiinflammatory drugs and corticosteroids to treat RA symptoms. But after the first wave of biologics hit the market, the next big step in the field was the introduction of auto-injectors, which have made it much easier for patients to dose themselves. “Since the new devices came out, the whole field has opened up,” says Mundy. “Cimzia and golimumab will need a device to bring to market. Then, dosing frequency will be the only difference. Right now, Humira is the leader, given subcutaneously and taken every two weeks with an injector pen. “The [new drugs] also have big companies behind them,” she adds. “The makers of Remicade [Centocor] have been advancing golimumab and have experience. They know how to take drugs out to doctors.” Once certolizumab, golimumab, and tocilizumab hit the market, says Mundy, “You’ll have quite an array of biologics. The next agent is ocrelizumab, a second-generation antiCD20 therapy by Biogen Idec and Roche. It’s very analogous to golimumab.” Now in late-stage studies, ocrelizumab is an antibody targeted at the CD20 surface antigen on human B cells, which cause inflammation when they run amok. The antibodies bind to CD20, then flag excess B cells for destruction. By depleting B cells, scientists have been able to trigger remission. Researchers also have been advancing late-stage research into the earlier use of rituximab, which also targets B cells. In late January, Genentech reported data “demonstrating that Rituxan improved symptoms of RA in patients who had not previously been treated with a biologic therapy,” said Hal Barron, MD, the company’s chief medical officer, in a news release. 34 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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