Shire’s long-delayed ADHD candidate has racked up more positive data in its quest to finally hit the market. And with FDA approval in sight, the drugmaker will have to find the space to compete.
The Dublin drugmaker announced last week that two dosage strengths of prospect SHP465 had beat a placebo in treating adult ADHD patients. Shire will add these results to a pile of 16 other SHP465 studies it intends to take to regulators, and it’s crossing its fingers for a green light to launch in the second half of 2017.
The company is hopeful it will, considering the positive Phase III data in pediatric patients reported back in April. The FDA requested that study in 2014 when it turned down SHP465, which is a long-acting version of Adderall XR.
Before that setback, Shire had predicted the drug--originally submitted to regulators in 2006--would bump up its share of the U.S. ADHD market to 5%. But now, it’ll be up to the company to carve out a place for the med amid rampant generic competition.
Shire has been looking to get as much mileage as possible out of its flagship ADHD franchise, and that goal has involved chasing after new indications, too. Not so long ago it snagged one for anchor drug Vyvanse in binge eating disorder, a label expansion that could add $200 million to $300 million to sales by 2020, or so CEO Flemming Ornskov has said. Ornskov also sees the potential for bigger peak sales down the line as awareness of the condition spreads.
At the same time, Shire has been looking to move beyond ADHD by throwing itself headfirst into the rare-disease field. It recently bolstered its position in that arena by swallowing Baxter's new spinoff Baxalta, a major player in the hemophilia space.
That’s not to say Shire wouldn’t like to keep churning out ADHD sales, and if its new candidate wins approval, the company will have the IP protection to do just that. If SHP465 gets the green light, it’ll net three years of Hatch-Waxman exclusivity, and it’ll have at least three patents with expiration dates as late as May of 2029, Shire said.
- read Shire's release
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