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

22 DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Cover Story Flockhart agreed that eventually things will go the way of RxDx, but it will take time. “The industry is very Yoking drugs slowly getting into this,” he said. view, is with diagnostics, “From investors’ point of test canitdo dividing the market. All a or RxDx, is gaining is decrease the number of prescriptions for their drug, so why are you momentum. going to do that?” he asked rhetorically. “It’s a model that I think upperlevel management embraces and appreciates, but the marketing people do not yet,” he added. Bayer HealthCare has a slightly different approach. The company has both a diagnostic and a pharmaceutical division and the teams from both areas work together to develop biomarkers for their oncology pipeline. Carney said that, in cancer patients, monitoring biomarkers from the start of a cancer diagnosis will have the most impact and clinical utility. His hope is to have a blood test that can be used with every targeted therapy from the initial diagnosis and continue throughout the patient’s life to monitor and manage therapeutic interventions. Although it sounds straightforward, Carney said it is not. He used Bayer’s sorafenib (Nexavar) as an example. Since the therapy works by inhibiting the Raf-kinase pathway and angiogenesis, it is difficult to know which pathway intermediate will be the best biomarker for the drug. Two potential biomarkers include vascular endothelial growth factor (VEGF) and the circulating fragDT CAPSULE ment of VEGF receptor 2, known as KDR. Research has shown that these biomarkers changed levels that were consistent with response to treatment with sorafenib. According to Carney, smaller biotech companies are doing a great deal of work in this area and will likely be acquired by larger companies. He mentioned Abbott and Roche as two companies looking to buy smaller firms working on new tests. In fact, in June of this year, Roche made a bid for Ventana Medical Systems at $75 per share, putting the sale at $3 billion. The offer, extended by Roche three times and due to expire Nov. 1, is grossly inadequate, according to a Ventana press release. The company believes it is “well positioned to capitalize on the significant potential of the emerging field of companion diagnostics and personalized medicine” and is worth significantly more than what Roche is offering. Ventana may be right. Right now, Ventana has partnerships with Genentech and eight other pharmaceutical companies. According to a recent report in Business Week, Ventana’s pipeline consists of approximately 30 projects in different phases of drug development. Celera is another player. It recently announced it has entered into a research collaboration with Merck & Co. to develop pharmacogenomic tests for cancer patients. Under the agreement, Celera will evaluate the use of Merck-identified “gene expression profiles” with the goal of potentially forming commercial companion diagnostic tests for oncology therapies. Celera also recently announced that it has discovered novel variants, in collaboration with researchers from both the Netherlands and Sweden, in the TRAF1/C5 gene region that predict susceptibility to, and severity of, rheumatoid arthritis. Trying to connect In spite of ongoing collaboration, the FDA has still not said exactly how the codevelopment process will work. In April 2005, the agency drafted the Drug-Diagnostic Co-Development Concept Paper and the intent was twofold, Felix W. Frueh, Ph.D., associate director of genomics in the FDA’s Office of Clinical Pharmacology, told Drug Topics. “We realized the use of these markers in drug development was becoming more and more important and that there was a void from a regulatory perspective,” he explained. There were also some regulatory and scientific considerations that we felt Source: Department of Health & Human Services. Food & Drug Administration. Drug-Diagnostic Codevelopment Concept Paper (on-line), www.fda.gov/cder/genomics/pharmacoconceptfn.pdf (2005) http://www.drugtopics.com http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf

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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