Shire ($SHPG) has said it's targeting $10 billion in sales by 2020, with $3 billion of that coming from its current pipeline. Now, it looks like an ADHD product waiting in the wings could be ready in time to help it get there.
The long-delayed SHP465, which shares an active ingredient with former lead product Adderall XR, could launch as soon as the second half of 2017, Shire said Tuesday after reaching an accord with the FDA on a regulatory path out of the clinic. The company has agreed to test the drug in children ages 6 to 17 in a short-term study so the agency can examine its effects on the population.
If the Dublin drugmaker does score an approval for the investigational product--a long-acting therapy that lasts 16 hours to Adderall XR's 12--it would be safe from generic competition until 2029, the company said. And for Shire, whose current top seller--fellow ADHD-fighter Vyvanse--expires in 2023, the extra copycat-free time could be huge.
But Shire has known for quite some time that it didn't want to put all its eggs in the ADHD basket, and lately it's been pushing hard into territories like rare diseases and GI for some variety. It's used M&A to further that aim, most recently striking deals for orphan drugmaker ViroPharma and GI specialist NPS Pharma.
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| Shire CEO Flemming Ornskov |
It's also taken its diversification strategy to Vyvanse itself, earlier this year scoring the FDA's first nod for binge eating disorder with the med. In February, CEO Flemming Ornskov predicted the new indication could tack on an extra $200 million to $300 million toward that 2020 sales benchmark.
- read Shire's release
Special Reports: Pharma's top 10 M&A deals of 2013 - Shire/ViroPharma | The 25 most influential people in biopharma today - 2013 - Flemming Ornskov - Shire