Shire’s Vyvanse Fails to Ease Major Depression in Studies

Feb 06, 2014 7:27 pm ET

(Updates with comments from analyst in fourth paragraph.)

Feb. 6 (Bloomberg) -- Shire Plc said it halted development of its best-selling drug Vyvanse as a treatment for depression after it failed to help patients in two studies.

The drug currently sold for attention deficit hyperactivity disorder didn’t significantly ease symptoms of major depression after four months in 830 adults, the Dublin-based drugmaker said today in a statement. The research was in the third and final stage of study typically needed for regulatory approval.

The results were the second setback for Shire’s research and development efforts since December, when its lifitegrast for dry-eye disease met only one of its treatment goals. Vyvanse was expected to reach the market for depression in 2016, with estimates it would generate about $300 million in sales within two years, said Jason Gerberry, an analyst at Leerink Partners in Boston, in a note to investors.

“We do expect sentiment to be negative given the failed study comes on the heels of some recent research and development setbacks,” he said. The setbacks may not reflect future advances as Chief Executive Officer Flemming Ornskov, who took the helm of the company on April 30, “has very different views from the old management team regarding the type of programs in which Shire will be investing going forward,” Gerberry said.

Shire, which generated $1.03 billion from Vyvanse in 2012, plans to file later this year for U.S. Food and Drug Administration approval of the medicine to treat binge eating disorder, Ornskov said in the statement. While the negative results in depression will crimp the company’s efforts to expand use of the drug for other ailments, Shire said it will continue to work on products for patients with ADHD.

‘Leading Treatment’

“Vyvanse is an effective and leading treatment for ADHD,” Ornskov said in the statement. “We remain committed to serving patients with ADHD and will invest in solutions to meet their treatment needs accordingly.”

The news came after the market close in London, where Shire rose 2.2 percent to 3,141 pence. The shares have gained 47 percent in the past 12 months.

Shire’s American depositary receipts declined 5 percent to $146 in extended trading at 6:16 p.m. New York time. Earlier, they had gained 1.7 percent to close at $153.75. Each receipt equals three ordinary shares.

--Editors: Andrew Pollack, Angela Zimm