LONDON (Reuters) - Shire has treated a generation of hyperactive American children with amphetamine-based stimulants. Now, with recognition of the condition growing in Europe, it believes the time is right to bring the franchise across the Atlantic.
The UK specialized drug company will file for European approval of Vyvanse, its next-generation medicine for attention deficit hyperactivity disorder (ADHD), by the end of the year and is optimistic after its product beat market leader Johnson & Johnson's Concerta in a clinical trial.
It will be watershed moment. No amphetamine-based drugs have been approved for ADHD in Europe, although drugs containing methylphenidates -- another stimulant, with similar effects as cocaine -- have been available since the 1950s and prescribed for ADHD since the early 1960s. Concerta is a long-acting version of methylphenidate.
While ADHD has been widely accepted and treated in the United States the condition is seen as more controversial in Europe, where consumers, parents and media have questioned the use of drugs like Ritalin, a version of methylphenidate developed by Novartis.
Longer-acting medicines such as Concerta and Novartis' Focalin XR are available to treat the condition today.
But some skepticism persists among European doctors about labeling hyperactivity as a mental disorder, although Michael Fitzgerald, professor of child psychiatry at Trinity College Dublin, said attitudes were changing.
"There's a prejudice about ADHD that it is a new-fangled American idea," he said. "There is considerable under-recognition of the problem in Europe. (But) it's improving all the time."
Shire, which is listed on London's blue-chip FTSE exchange, launched Adderall -- a mixture of amphetamine salts -- in 1996 in the United States but never brought it to Europe.
Since Adderall's last existing patent expired in 2009, Shire has focused on Vyvanse, which is growing more than twice as fast as the overall U.S. market for hyperactivity drugs as doctors switch prescriptions.
Vyvanse has a different delivery mechanism than Adderall, in that the drug can only be absorbed through the gut and cannot be crushed for injection, limiting the potential for abuse. Its effect also lasts long after the end of the school day.
With the strong results from Vyvanse's head-to-head trial against Concerta in October, Shire reckons it has a winning formula for Europe too.
"(The trial) shows the effectiveness of Vyvanse and also how it fits into the mainstay of treatment in Europe, which currently is long-acting methylphenidate, and we believe for some patients Vyvanse may be a better option," said Arnaud Partiot, Shire's European head of ADHD.
"We think we have a potentially very successful molecule to bring to the market."
Shire, which specializes in drugs for rare diseases and gastrointestinal complaints as well as ADHD, is growing faster than its Big Pharma rivals GlaxoSmithKline and AstraZeneca which are suffering as big-name patents expire.
ADHD UNDER-DIAGNOSED?
In the United States about 9.5 percent of children aged 4-17 years were diagnosed with ADHD as of 2007, according to the Center for Disease Control and Prevention. Some two-thirds, about 2.7 million, were receiving medication at that point.
Diagnosis rates in Europe are much lower, said Andrea Bilbow, chief executive of British ADHD charity ADDISS.
"There are no exact figures, but we know it is hugely under-diagnosed," she said, adding there were large differences in awareness in the region, with Scandinavia and Germany at the top and France and Italy at the bottom.
Children with ADHD are excessively restless, impulsive and easily distracted, and they often struggle in school.
Shire's Partiot said awareness of the condition in Europe would gradually rise.
"ADHD will mimic other diagnoses in the psychiatric area, where it started from being very U.S. centric, then people realize it is real, it exists and there's a prevalence that is the same across the world," he said.
"When you listen to parents and patients of course they are worried about treating children -- you are worried about treating children in any disease -- but when they are recognized and treated, they are relieved."
RELUCTANCE TO MEDICATE?
Analysts, however, said reluctance to medicate could limit the opportunity for Vyvanse in Europe.
"No amphetamines are approved in Europe at the moment for ADHD," said Peter Welford at Jefferies, adding that Shire faced an uphill battle, though the drug's delayed release mechanism improved its chances.
"For the market potential to be material for Shire, to be anywhere near the U.S., would require a leap of faith," he said.
Another analyst, who declined to be named, said sales would not be more than about $200 million five years after launch.
"European prescribers are going to ask 'Do I want to use speed? Am I going to have students going on speed just to boost their exam grades?'," he said.
But ADHD expert Fitzgerald at Trinity College said Vyvanse would be welcomed by doctors as an alternative to current medication, including non-stimulant drugs, and behavioral therapy.
"The timing is absolutely right," he said. "We always need extra medications because not every medication suits everybody, so it just gives us another string to our bow."
Paul Beresford of Shire's ADHD team added: "Having a product that has been demonstrated to last 13 hours is important ... and it's difficult getting that control with the current therapies and medications available in the marketplace."
After Europe, Shire's ambitions for Vyvanse stretch into Japan, where it struck an agreement last month with a local partner Shionogi & Co.
It also plans to use the drug in new areas such as depression, schizophrenia and binge eating [ID:nL5E7MI15V]. It performed well in a Phase II trial in boosting alertness when used with antidepressants in patients with major depressive disorder last week. [ID:nL5E7N82E9]
(Editing by Ben Hirschler and Sophie Walker)
