Drug Topics - December 10, 2007 - (Page HSE6)

6 HSE DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com > > > Special Report SPECIAL(TY) DELIVERY Pharmacy directors see the 2008 pipeline chock-full of specialty drugs and compounds Elena Beyzarov, Pharm.D. f there were one word to characterize potential new drug approvals for 2008, or for the foreseeable future, it would most likely be specialty. Generally described as high-cost biotechnology treatments that involve genetic engineering, oncology/rare disease indications, and complex administration (e.g., in-office injection), specialty drugs have taken the industry by storm, essentially becoming “their own trend drivers,” asserted Lon Castle, Pharm.D. “The drugs in this category are growing at a faster rate than diabetes and lipid-lowering drugs combined, and they’re grabbing indications from virtually all therapeutic areas,” noted Castle, director of medical policies and clinical quality at Medco Health Solutions. From 1982 to 2005, 254 biotech drugs were approved for 385 indications, and by 2010, half of the Food & Drug Administration Specialty drugs are approvals will be special“growing at a faster rate ty drugs, according to Richard J. Faris, Ph.D., than diabetes and lipidR.Ph., VP of health outlowering drugs combined.” comes solutions at Accredo Health Group in TenLon Castle, Pharm.D. nessee. He was speaking Medco Health Solutions about the pharmacy pipeline at the recent National Association of Chain Drug Stores Pharmacy & Technology Conference. Bevacizumab (Avastin, Genentech) alone is involved in 130 clinical trials, covering 25 different tumors, noted Faris. And when it comes to pharmacy budgets, “specialty drugs are the single largest driver of cost from year to year, accounting for nearly 25% of the growth in drug spending in 2006,” said Castle. According to the 2007 Drug Trend Report released by Medco Health Solutions, spending has primarily been driven by the increased costs of treatments for cancer, rheumatoid arthritis (RA), and multiple sclerosis (MS). Emerging specialty therapies include immunomodulators for inflammatory diseases—e.g., Crohn’s disease (CD), lupus, RA, MS—oral therapies for hepatitis C and MS, and more selective oral cancer drugs. “For the near term, there are no revolutionary oncology compounds. But, in general, there has been a 25% increase in the development of oral drugs that can target particular cancers more effectively, and with that, a shift to more patient-directed ther- I apy,” commented Christopher Peterson, Pharm.D., director of emerging therapeutics at Express Scripts. Among these highly targeted agents are satraplatin (Spectrum Pharmaceuticals), the first and only orally bioavailable platinum agent under development for hormone refractory prostate cancer, and vatalanib, an oral inhibitor of vascular endothelial growth factor under investigation for colon cancer. Peterson believes that the management of cancer will eventually be similar to that of HIV, for which patients may be treated chronically with an individualized cocktail of pharmacologically complementary oral drugs. Immunomodulating agents With so much research implicating the immune system in the pathogenesis of major inflammatory disorders, it’s not surprising to see a flurry of activity in the immunomodulating arm of the specialty pipeline. One such agent that will likely be approved for CD in 2008 and for RA at a later time is certolizumab pegol (Cimzia, Nektar), a oncemonthly subcutaneously (SC) injected pegylated antitumor necrosis factor (TNF) antibody. Similar to adalimumab (Humira, Abbott), which just received an indication for CD but is injected biweekly, certolizumab has a high affinity for TNF-alpha, a cytokine that has long been suspected to play a role in various autoimmune disorders. In phase III studies, approximately 85% of patients with CD receiving 400 mg of certolizumab monthly maintained a clinical response at week 80, with 74% achieving remission. Although certolizumab was well tolerated (<2% incidence of injection-site reactions), Peterson questioned how its prolonged duration of action and potential accumulation may impact long-term safety. Golimumab (Centocor/Schering-Plough), a fully humanized monoclonal anti-TNF antibody, is another specialty immunomudulating agent that is being studied for RA and will likely receive FDA approval in the second half of 2008. This agent is similar to infliximab (Remicade, Centocor)—a chimeric human-murine monoclonal antibody requiring IV infusion—but it “offers the advantages of SC injection and potentially fewer allergic-type reactions due to absence of a mouse antibody component,” noted Peterson. The use of golimumab with methotrexate was shown in phase II studies to produce and maintain (over 52 weeks) Continued on page HSE11 http://www.drugtopics.com

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Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

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