Q1 Earnings Calls, In Brief
Forest hopes for Lexapro adolescent depression indication: Forest plans to submit an sNDA for Lexapro (escitalopram) to add an indication for adolescent depression, President Larry Olanoff said during a fourth quarter fiscal year 2008 earnings call April 15. Lexapro sales increased 9 percent this quarter to $577 million from $530 million in the year-ago quarter. Forest has a number of drugs in late-stage development in its pipeline, including aclidinium, in development for chronic obstructive pulmonary disease, ceftaroline for serious hospital infections, linaclotide for chronic constipation, RGH-188 for schizophrenia and bipolar disorder and milnacipran for the treatment of fibromyalgia. Forest projects spending $625 million in fiscal 2009 on R&D, and excluding initial licensing payments, plans to boost R&D spending by 27 percent from 2008 levels. No stroke signal for Forest's pulmonary disease drug: While Pfizer/Boehringer Ingelheim's chronic obstructive pulmonary medication Spiriva (tiotropium bromide monohydrate) may be linked to stroke, according to a March 18 alert from FDA's MedWatch, Phase II and III study data for Forest's aclinidium are not raising any concerns, said Olanoff. "We are not seeing anything to raise any alarms and are still waiting to determine whether it's a real finding even with Spiriva," he said. He also pointed to the drug's patient population - elderly people, many who have a long smoking history and are already prone to cardiovascular events. FDA has not contacted Forest about stroke signals and the company expects to be able to make an accurate estimation for rate of strokes with the drug
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