Shire is hoping to overcome European skepticism about amphetamine-based stimulants for ADHD and snag an approval for Vyvanse by the end of the year.
As Reuters notes, there are no amphetamine-based drugs available in Europe for the condition. The drugmaker has sold Vyvanse in the U.S., where ADHD is a widely accepted. But there is lingering skepticism in Europe. "There's a prejudice about ADHD that it is a new-fangled American idea," Michael Fitzgerald, professor of child psychiatry at Trinity College Dublin, explains, as quoted by Reuters. "There is considerable under-recognition of the problem in Europe. (But) it's improving all the time."
Still, some analysts foresee problems for Vyvanse, as European doctors may be reluctant to medicate for the condition, Reuters notes. "No amphetamines are approved in Europe at the moment for ADHD," says Jefferies' Peter Welford, who notes that though Vyvanse faces a battle its delayed release mechanism could improve its chances. Shire's ADHD team is confident, despite the odds. Paul Beresford notes the drug has been shown to last 13 hours, an important advantage.
One unnamed analyst says sales of the drug would be no more than about $200 million 5 years after launch.
Shire's Vyvanse ambitions don't end with Europe. It is eyeing Japan next, having already inked an agreement with that nation's Shionogi.
- see more from Reuters