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Shire (SHPG) Updates Vyvanse Label with New Efficacy Data


Shire plc SHPG announced that it has updated Vyvanse’s label to include data associated with its supplemental New Drug Application (sNDA) for the treatment of adults with moderate-to-severe binge eating disorder (B.E.D.).

The updated label includes data from a phase III study, SPD489-346, which demonstrated significant maintenance of efficacy based on the primary endpoint of time to relapse, in comparison to placebo.

Note that Vyvanse is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged six and above, and for the treatment of moderate-to-severe B.E.D. in adults. It is, however, not recommended for obesity or weight loss.



In the first six months of 2016, Vyvanse garnered revenues of over $1 billion, driven by increased use in adults in the U.S. and continued growth in international markets. The drug accounted for 26% of Shire’s total revenue during this period.

We remind investors that in Apr 2016, the company submitted a New Drug Application (NDA) in the U.S. for a chewable tablet formulation of Vyvanse. Shire believes that the chewable tablet will be easy to consume for patients who may have difficulty in swallowing or opening a capsule.

Shire holds a strong position in the ADHD market, with Vyvanse as its growth engine of the company. Apart from Vyvanse, the company has other ADHD drugs like Intuniv and Adderall XR in its portfolio.

We are encouraged by Shire’s efforts on a label expansion of Vyvanse. Shire currently carries a Zacks Rank #3 (Hold).

Stocks to Consider

Some better-ranked stocks in the health care sector are Exelixis, Inc. EXEL, Incyte Corporation INCY and Geron Corporation GERN. All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis has beaten earnings estimates twice in the last four quarters with an average surprise of 9.10%.

Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters, with a massive average surprise of 335.16%.

Geron has delivered a positive earnings surprise twice in the last four trailing quarters, bringing the average beat to 20.78%.

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