Vyvanse set to steal ADHD share in back-to-school meds rush

As kids start heading back to school--and getting back on their ADHD meds--one analyst expected Shire's ($SHPG) Vyvanse to steal market share from Johnson & Johnson's ($JNJ) Concerta. And so far, the med is meeting his expectations.

Vyvanse has reached 32% of the segment, according to Bernstein analyst Ronny Gal--and "if the next couple of weeks are as strong, 2H15 numbers will have to come up," he wrote in a recent note to investors.

Gal had predicted that Concerta, which usually gains share during August--the month where kids who stopped taking "sit-quietly-in-class" drugs start them up again for the new school year--would cede share to Vyvanse, given the "mess" with Concerta generics. Back in November, the FDA gave Mallinckrodt ($MNK) and UCB 6 months to prove that their knockoffs were substitutable for the brand--or pull the copycats, which wear off more quickly than Concerta, from the market.

As of June, though, that deadline had come and gone, with no final word from the agency on the meds. "It's the first time we're seeing something exactly like this," Gal told The New York Times at the time. "I kind of thought the FDA would tell them to go away. They haven't."

Flemming Ornskov, CEO of Shire

It's an opportunity for Shire, which has been working hard to broaden its leading product's reach. The Irish pharma is testing the drug in preschoolers, and earlier this year, Vyvanse won the FDA's first-ever approval for Binge Eating Disorder--an indication that CEO Flemming Ornskov has said could help the therapy rake in an extra $200 million to $300 million.

That's not to say the Dublin drugmaker hasn't been trying to diversify beyond its flagship ADHD franchise, though. On the contrary, it's been building up its rare-disease portfolio over the last couple years--a goal it's aiming to further with this month's $30 billion bid for hematology specialist Baxalta ($BXLT).

Special Report: The 25 most influential people in biopharma today - 2013 - Flemming Ornskov - Shire