Shire Plc (SHP) said its Vyvanse treatment for attention deficit hyperactivity disorder proved effective in treating people with binge-eating disorder.
The pill was superior to a placebo in curbing the number of binge days per week for 773 patients after taking the medicine for about 12 weeks, the drugmaker said today in a statement. Shire, based in Dublin, wasn’t expecting to report the data until early next year.
The study was the last stage of clinical testing usually needed before winning regulator approval and Shire plans to apply for U.S. Food and Drug Administration clearance in the third quarter of next year, “suggesting approval and launch in 2015,” according to a report today by Deutsche Bank analysts, who said they expect Vyvanse’s binge-eating sales to reach $220 million in 2017.
Shire rose as much as 2.6 percent and was up 1.6 percent at 2,864 pence at 10:25 a.m. in London trading. The shares have gained 52 percent so far this year, lifting the stock to all-time highs and a market value of 15.8 billion pounds ($25.4 billion.)
The study is a boost for Shire’s plan to expand Vyvanse in new disease areas while introducing the drug for patients with ADHD in countries outside the U.S. Shire plans to seek approval for Vyvanse to treat major depressive disorder late next year. Vyvanse, Shire’s best-selling drug, generated $1.03 billion for the company last year, a 28 percent gain from 2011.
“Should approval for Vyvanse in binge-eating disorder be confirmed, that may also help the roll out of Vyvanse outside of the U.S., where medical and cultural hurdles to the use of amphetamine-based drugs in ADHD, especially in children, are relatively high,” Stephen McGarry, an analyst at Societe Generale (GLE), wrote in a note to clients today. McGarry raised Shire’s target price to 3,270 pence from 3,140 pence.
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