Generic approval for Shire’s hyperactivity drug
pharmafile | June 26, 2012 | News story | Sales and Marketing | ADHD, Adderall XR, FDA, IMS Health, Impax, Shire, Teva
US regulators have delivered a blow to Shire by allowing Actavis Group to produce a generic version of its hyperactivity drug Adderall XR.
Shire says it will ‘remain competitive’ in this therapy area through its own branded medicine and its link-up with Teva and Impax, who have authorisation for the two generic versions currently approved.
Together these saw US sales of $1.99 billion for the 12 months to 31 March this year, according to figures from IMS Health.
But Shire acknowledges it is now in for a bumpier ride, saying: “There will be multiple dynamics affecting the overall market following the approval of the Actavis generic.”
Following the FDA’s decision – which some observers did not expect for another year – the main pressure is likely to be financial, with a third generic on the market driving prices down.
Doug Boothe, chief executive of Actavis in the US, said: “With ADHD class medications experiencing shortages in 2012, this important product will offer value and supply to the marketplace.”
Actavis says distribution of its product has already started and shares in Shire dropped 13% the day after the FDA announcement.
Shire insists it will still deliver good earnings growth for 2012 – but analysts believes the news could mean a drop of five percentage points in Shire’s earnings per share growth this year “and significantly more next year if other generics enter the space”.
“Shire will now need the rest of its pipeline and in particular Vyvanse to perform strongly,” says EP Vantage.
ADHD brand Vyvanse has been doing well, giving Shire sales of $805m in 2011 – a 27% increase on the previous year and well ahead of the market growth in this therapy area.
Adam Hill
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