Shire to target Europe as ADHD market opens up

By Mark Potter

LONDON, Feb 9 (Reuters) - Europe's scepticism over attention deficit hyperactivity disorder (ADHD) is starting to lift, opening up a market that could grow to $1 billion-a-year by 2012-13, British drugmaker Shire Plc (SHP.L) believes.

Shire, whose Adderall XR is the top-selling treatment for ADHD in the United States, has not even tried to get the drug approved for sale in Europe as psychiatrists have been divided on the existence of the condition, let alone how to treat it.

But Chief Executive Matthew Emmens told Reuters that attitudes were changing and Shire planned to launch two of its next generation of ADHD treatments, skin patch Daytrana and Vyvanse, a successor to Adderall XR, in Europe in 2008 and 2009 respectively.

In particular, he was encouraged by two so-called "opinion leader" meetings of psychiatrists in Europe last year.

"For the first time, we're seeing a willingness to not only accept it (ADHD) as a disorder, but to recommend treatment in Europe, in particular for adults," he said in an interview.

The U.S. market for treating ADHD, which is characterised by impulsive behaviour and short attention spans, is worth about $3.5 billion a year and growing. In Europe, the market is virtually non-existent.

Emmens said Europe's attitude toward ADHD bore parallels to its response to depression, with an initial scepticism towards treating the condition through drugs giving way to a general acceptance, though not as broad as in the United States.

"If they (ADHD treatments) are priced like they are in the U.S., you've probably got the potential for a $1-billion market in Europe ... by around 2012-13," he said.

Europe's reluctance to adopt anti-depression drugs was overcome by hard clinical evidence, and Emmens believes the effectiveness of ADHD drugs is now indisputable.

"We've seen kids go from C-grades to As and adults go from failure in their profession to being able to hold down a job and do it well."

But if ADHD medicines have proved their efficacy, there have still been question marks over their safety.

SAFETY

Most ADHD drugs are stimulants, including Adderall XR which is an amphetamine, and they have to be carefully stored and administered to avoid abuse or overdose.

Adding to concerns, Canadian regulators slapped a surprise ban on Adderall XR in 2005, saying they wanted to investigate the sudden death of a small number of patients, and U.S. regulators also launched an inquiry into ADHD drugs.

Both investigations, however, concluded the drugs were safe, although warnings of potential side effects were stepped up on some medicines, and Adderall XR is back on sale in Canada.

Emmens said the safety scare slowed growth in the U.S. market for ADHD drugs down to around 3 percent, but that it had recovered to around 4.5 percent currently and was likely to rise to its long-term trend of 6-8 percent this year.

Growth was likely to be fuelled by Shire's new suite of ADHD treatments, led by Vyvanse, which is expected to be approved by U.S. regulators towards the end of February, he said.

Vyvanse, while still an amphetamine, is not absorbed until it reaches the stomach and so does not give the hit that can appeal to abusers.

Shire and its U.S. partner on the drug, New River Pharmaceuticals NRPH.O, hope this will be reflected in the advice label approved by U.S. regulators. This could be crucial to persuading doctors and patients to switch from Adderall XR, which loses patent protection in 2009.

((Editing by Paul Bolding; Reuters Messaging: rm://mark.potter.reuters.com@reuters.net

Tel: +44 20 7542 7717, Fax: +44 20 7542 9025)) Keywords: SHIRE/

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