Biotechnology Healthcare - July/August 2008 - (Page 7)

DRUG TRACK Research, Conferences, and FDA Actions Michael D. Dalzell, Editor Gastrointestinal agents Centocor is touting a new analysis of two large-scale trials of infliximab (Remicade) that suggest that the TNF-α inhibitor induces rapid response in patients with moderate to severe ulcerative colitis — regardless of how long they have had the disease. Of 1,200 patients enrolled in two multicenter phase 3 trials, more than 60 percent showed clinical response after 8 weeks. The studies enrolled patients with inadequate response to conventional therapies. The analysis was presented at the annual Digestive Disease Week (DDW) meeting in May. At the same meeting, NPS Pharmaceuticals reported mixed phase 3 data on teduglutide (Gattex) in patients with short bowel syndrome. Patients who received lower doses had statistically significant reductions, versus placebo, in the need for parenteral nutrition. Those given higher doses showed a nonstatistically significant reduction. A confirmatory study is planned. One of the more interesting studies presented at DDW examined the effects of a regimen to combat hepatitis C in a difficult-to-treat population. Latino patients infected with genotype 1 HCV showed sustained improvement when given peginterferon alfa-2a (Pegasys) in combination with ribavirin (Copegus). Investigators say the results of the open-label study are important because the literature has documented more aggressive inflammatory activity and fibrosis progression and lower sustained virological response in Latino populations with this form of hepatitis C than in other groups. Rheumatology trials Roche released results of a fifth phase 3 study of tocilizumab (Actemra) that demonstrated inhibition of joint damage in patients with rheumatoid arthritis. Over 12 months, patients given tocilizumab in combination with methotrexate had statistically significant better outcomes than those who received methotrexate alone. The five studies are part of Roche’s new drug application for tocilizumab, which blocks interleukin 6. In a head-to-head trial, Amgen’s denosumab produced superior gains in bone mineral density in postmenopausal women compared to alendronate (Fosamax). In this nonpivotal, phase 3, 12-month study, patients received either two denosumab injections or weekly doses of alendronate. Meeting highlights American Society of Clinical Oncology (ASCO) June 2008 Data compiled from a smattering of small studies suggest that more than a third of patients receiving cetuximab (Erbitux) for colon cancer have a mutation in the KRAS oncogene that negates the effect of the drug. The findings were reported in 1 of 15 abstracts that probed the significance of the KRAS mutation. Another suggested that panitumumab (Vectibix) may be more effective in colorectal cancer patients with wild-type KRAS than in those with mutant KRAS, and yet another suggested that KRAS status could predict outcomes of lung cancer patients treated with an EGFR-TKI, such as erlotinib (Tarceva) or gefitinib (Iressa). Manufacturers are using emerging KRAS data to refine marketing efforts; a Genentech official told the Wall Street Journal that every future compound in development will have a biomarker test to help to identify the right patients for a given drug. Other ASCO news indicates that lung cancer remains a fertile area of study: The addition of cetuximab to chemotherapy adds about five weeks to a patient’s life — not as long as the survival benefit of bevacizumab (Avastin), but perhaps enough to give it a niche among patients who cannot tolerate bevacizumab. In higher doses, celecoxib (Celebrex) may prevent lung cancer in heavy smokers. A German researcher presented a blood test he says predicted lung cancer diagnoses with 80 percent accuracy in outwardly healthy smokers. Other selected presentations: Evidence suggests that zoledronic acid (Zometa), the bone drug, may prevent breast cancer recurrence. Lenalidomide (Revlimid) triggered response in a subset of patients with nonHodgkin’s lymphoma, and a 65 percent response rate in multiple myeloma patients given concurrent bortezomib (Velcade). A new analysis of the pivotal phase 3 study for temsirolimus (Torisel) demonstrated median overall survival of 10.9 months versus 7.3 months for patients given interferon-α and who had three specific risk factors. JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 7

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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