Shire Braced for US Study Into Risks Of Attention Deficit Drug
From Guardian (UK) (June 28, 2010)
The pharmaceutical group Shire is braced for a report from US regulators on the safety of drugs used to treat attention-deficit hyperactivity disorder (ADHD), which could affect almost a third of its annual sales of $3bn (pounds 1.9bn).
Findings from the study by the US Food and Drug Administration (FDA) and US health department into ADHD medicines that use stimulants such as amphetamines are due in August. The study was launched in 2007 amid concern about the potential for increased risk of heart attack, stroke or other cardiovascular problems when the drugs are used by children and adults.
ADHD is a behavioural disorder that can have a significant impact on social performance and functioning. The US National Institute of Mental Health says it affects 3% to 5% of school-age children.
According to the FDA, the most commonly prescribed paediatric ADHD drugs include Shire’s Adderall, Johnson & Johnson’s Concerta and Eli Lilly’s Strattera. But Shire, a FTSE-100 company, is more dependent on income from ADHD medicines than most of its rivals, although it has been diversifying to expand its portfolio.
A spokeswoman for the British firm said: "We are not complacent. It is right that the FDA should look at the issue, but we are confident that we have a good product and that it meets a need.
"We have a range of medicines and aren’t dependent on any one drug."
Shire gave up the right to exclusively distribute Adderall in 2009 after challenges by rivals. Adderall sales have fallen, but the firm aims to reverse the setback by promoting its newer ADHD drug, Vyvanse, which also contains amphetamine.
In 2005 Adderall was briefly suspended from sale in Canada because of 20 sudden deaths and 12 strokes among mainly child users. However, the product was later allowed back to the market with a "black-box warning" about use by patients with underlying cardiovascular problems.
A research paper from Sanford Bernstein says the FDA might not change anything because of the "black-box warning". But the FDA could toughen recommendations by telling doctors to ensure that patients undergo compulsory cardiovascular testing before ADHD drugs are used.
Bernstein notes that in 2008 the American Heart Association had a spat with the American Academy of Paediatrics after suggesting children should be tested for cardiac abnormalities before starting treatment. The American Heart Association eventually reversed its stance. The broker says: "It seems very likely that stimulant medications used to treat ADHD increase the risk of serious, even fatal, cardiovascular events in some patients . . . but the absolute risk seems extremely small."
Deutsche Bank analysts said: "The key risk to the shares relates to an FDA safety review of stimulants in ADHD but we attach a low probability to an adverse outcome given that stimulants have been in use for over 30 years with no firm evidence of cardiovascular risk."
Shire offset the decline in revenues and profit from Adderall via a strong performance from Replagal and Vpriv that are used to treat childhood genetic conditions. Intuniv, a new ADHD drug that does not use a stimulant also boosted sales.
Posted: June 2010