Shire bullish on 2017 approval of new, longer-lasting ADHD pill
- Investors are excited about the prospects for Shire's latest ADHD drug-in-development, SHP465.
- This drug is intended to control symptoms of ADHD for up to 16 hours, one-third longer than Shire's long-acting and best-selling ADHD drug Adderall XR.
- Based on feedback from the FDA, Shire believes that SHP465 could be approved within two years, and its patent will extend until 2029.
Shire boasts a strong ADHD portfolio, which includes not only Adderall, but also Vyvanse, which is used to treat ADHD, and recently gained FDA approval for treatment of binge-eating disorder. Vyvanse had more than $1 billion in revenues last year, placing it firmly in the blockbuster category. While Shire's large-scale goal is to generate $10 billion a year in annual sales by 2020, a major part of its focus is keeping its ADHD franchise profitable and growing while staving off generic competition.
When the Adderall XR patent expired in 2009, Shire focused on switching over as many patients as possible to Vyvanse. That strategy has been largely successful. However, in eight years, Vyvanse will lose patent protection.
That's why continued R&D with a focus on improving treatment options for patients with ADHD is the best strategy for Shire, which often cites its long-term goals and continues to be forward-looking in its approach to R&D.