Drug Topics - October 22, 2007 - (Page 25)

www.drugtopics.com OCTOBER 22, 2007 DRUG TOPICS 25 Cover Story were necessary to put out just to clarify that the codevelopment process is not that different from the way we currently assess drugs and diagnostics, he added. “The part that goes without saying is that we think this is a really great idea and we want to encourage people to do it.” But despite agency enthusiasm, others in the industry are skeptical on issues such as potential increased cost associated with bringing two products to market rather than one and the need for a regulatory pathway to perform such a task. According to Gail H. Javitt, J.D., M.P law and policy director at the Genetics & Public .H., Policy Center at Johns Hopkins University, the codevelopment of drug and test seems like an excellent idea and would appear to provide significant benefit to clinicians and patients. However, the outstanding questions will be whether the business model works for the in-vitro diagnostic (IVD) and pharma industries, and whether the different branches of the FDA will be sufficiently coordinated to have the codevelopment go smoothly. Frueh responded to the cost issue by pointing to the story of trastuzumab. “Whether or not this is going to result in added cost, in my view, is an open question. Because if you look at the economic model that was presented in the case of Herceptin, it’s safe to say that Herceptin would not have seen the light of day if it had not been for the biomarker used during development.” Janet Woodcock, the FDA’s deputy commissioner and chief medical officer, agrees. She has said that diagnostics will be key to launching more targeted treatments and that the industry could greatly benefit from the approach. She added that companies may be able to get very high response rates from very small clinical trials. This could actually shorten a product’s time to approval. Also, testing for a genetic predisposition to adverse effects of a drug can eliminate the inappropriate individuals from studies and may end up improving the safety profile of a therapy. Another concern of manufacturers is whether diagnostic testing will eventually be required if the agency knows a biomarker or related test exists. Currently there is no agency rule that says codevelopment must be performed; however, the FDA has notified companies when it feels a test is warranted. Earlier this year, the agency notified Amgen that it would be required to submit a supplemental BLA for the diagnostic kit that was used to select patients for clinical trials involving panitumumab (Vectibix), an inhibitor of epidermal growth factor receptor (EGFR). According to the FDA, the test, Dako’s PharmDx EGFR kit, looks for the presence of EGFR on malignant cells, and since panitumumab binds to EGFR, its presence is considered to be required in order for the biologic to exert its effect. Roughly 30% of patients screened were not enrolled in the study because of a lack of EGFR expression. The FDA will now coorDT CAPSULE dinate the review of both the kit and the safety and efficacy reviews of the The FDA may offer BLA at the same time so that regular approval of each counterpart manufacturers would be simultaneous. Vectibix was given accelerated approval in incentives for September 2006 for the treatment developing this of metastatic colorectal cancer. Questions also remain regarding new twosome. the level of investment in diagnostics and the amount of reimbursement they will receive once approved. Until the public recognizes the value of a diagnostic, many think it will be difficult to receive adequate reimbursement. Historically, diagnostics have been viewed as having less value than drugs themselves. Insurers are also concerned that paying for expensive genetic tests will wipe out any potential savings they might see from the use of targeted drugs. Future for two Despite the concerns, development continues, partnerships are forming, and the FDA hopes to release an updated version of its concept paper on the subject by the end of this year. “This area is so new that it’s probably going to be very difficult to come out with a final document,” Frueh pointed out. “A lot of it is in flux and a lot is conceptual, because we still lack good examples.” If we had a history of codevelopment, we wouldn’t still be using Herceptin as an example of how the process can work from beginning to end, he joked. To help spur RxDx development, offering incentives to manufacturers is something that the FDA is also considering. “We’ve been talking about this on and off in a variety of settings,” confirmed Frueh. He pointed to the incentives that have been created in the areas of orphan drugs or pediatrics as examples. If you can characterize a disease on a molecular level in such a way that there are fewer than 200,000 patients in the United States at any given time, then you actually do have an orphan indication, he explained. “One could certainly envision that a drug-test-codeveloped product might get some additional exclusivity because, on one hand, it’s more likely that they are identifying the patient population that indeed does benefit. But, at the same time, they are cutting down their market at least to some extent.” Frueh was quick to point out, however, that nothing has been decided yet. “I am of the camp of people who believe that more should be done and incentives certainly would spur the development of tests along with the new drugs. The bottom line is that RxDx will “provide more effective drugs with fewer side effects—and that’s huge,” he concluded. 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Table of Contents Feed for the Digital Edition of Drug Topics - October 22, 2007

Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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