Shire plc (SHPG - Free Report) announced positive top-line results from two phase III studies on attention deficit and hyperactivity disorder (ADHD) drug Vyvanse for additional indications.
We note that Shire is developing Vyvanse for additional indications such as the treatment of negative symptoms of schizophrenia and binge eating disorder (BED).
The two randomized phase III studies were conducted to evaluate the safety and efficacy of Vyvanse compared to placebo in adults suffering from BED. The results from the study showed that Vyvanse was statistically superior to placebo on the primary efficacy analysis while maintaining a safety profile.
Consequently, Shire plans to submit a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for the treatment of BED in adults (ages 18 to 55) by the third quarter of 2014.
We are also encouraged by Shire’s efforts for the label expansion of Vyvanse. We remind investors that Shire holds a strong position in the ADHD market driven by key drugs like Vyvanse, Intuniv and Adderall XR.
Shire’s growth engine is Vyvanse, which accounted for approximately 24.4% of total revenues in the first nine months of 2013. Shire is now focused on exploring Vyvanse outside the U.S. Vyvanse (under trade name Elvanse) was approved in the EU in Dec 2012. Shire plans to capture 75% of the total EU market by 2014.
Shire currently carries a Zacks Rank #1 (Strong Buy). Other stocks that currently look attractive include Forest Laboratories , Salix Pharmaceuticals and NPS Pharmaceuticals, Inc. . All three carry a Zacks Rank #2 (Buy).