• Basilea Pharmaceutica Ltd., of Basel, Switzerland, reported Phase III results showing that patients with severe chronic hand eczema can benefit from re-treatment with alitretinoin. In two previous randomized clinical trials, alitretinoin was found to be effective in treating severe chronic hand eczema in patients refractory to topical treatments, and the latest trial demonstrated that patients responsive to initial treatment with alitretinoin also can benefit from additional treatment courses after eventual disease recurrence. The safety profile of alitretinoin observed in this study was consistent with previous trials, and the new data will be integrated into regulatory submissions planned for later this year.
• CV Therapeutics Inc., of Palo Alto, Calif., said data from the MERLIN TIMI-36 study will be published in this week's issue of The Journal of the American Medical Association. The company plans to ask the FDA to modify the existing product labeling for Ranexa (ranolazine) in extended-release tablets by reducing cautionary language and expanding the indication to include first-line angina. The JAMA data showed that patients with acute coronary syndromes (ACS) receiving Ranexa had no adverse trend in death or arrhythmias and had statistically significant reductions of clinically significant arrhythmias (p<0.001) and recurrent ischemia (p=0.03), compared to patients receiving placebo. Despite a trend toward a reduction in the composite primary endpoint of cardiovascular death, myocardial infarction and recurrent ischemia, the study did not meet the primary efficacy endpoint with statistical significance (p=0.11) in a new patient population, ACS. The company's stock (NASDAQ:CVTX) closed Wednesday at $8.61, up 72 cents.
• Exelixis Inc., of South San Francisco, submitted an investigational new drug application for XL765, a small molecule shown in preclinical studies to inhibit the activity of phosphoinositide-3 kinase (PI3K), as well as the mammalian target of rapamycin.
• Genentech Inc., of South San Francisco; OSI Pharmaceuticals Inc., of Melville, N.Y.; and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, reported that study results show a 22 percent improvement in survival when Tarceva (erlotinib) is added to gemcitabine chemotherapy in patients with advanced pancreatic cancer. A higher percentage of patients were alive at 12 months in the group treated with Tarceva plus gemcitabine (23 percent) compared to those treated with chemotherapy alone (17 percent). Progression-free survival also improved significantly for patients in the Tarceva group. Results were published in the Journal of Clinical Oncology.
• MediGene AG, of Munich, Germany, completed patient recruitment for the Phase II trial of EndoTAG-1 for the treatment of pancreatic cancer. The last of the 200 patients enrolled received treatment for the first time and will be monitored for six months. MediGene expects the final results in the first six months of 2008. EndoTAG-1, a combination of the cytostatic drug paclitaxel and a targeted delivery system made up of cationic lipids, destroys tumor blood vessels.