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Shire plc (SHPG - Analyst Report) recently announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) for review and issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013. The company is looking to get Vyvanse approved as a maintenance treatment in children and adolescents aged between 6 and 17 years with attention-deficit/hyperactivity disorder (ADHD).

In May 2012, the company had presented data from a phase III study at the EUNETHYDIS 2nd International ADHD Conference. In this phase III double-blind, placebo-controlled, randomized study, long-term maintenance of efficacy and safety of Vyvanse in children and adolescents aged 6 to 17 years with moderately symptomatic ADHD was evaluated. Significantly less treatment failures were observed in the Vyvanse arm (13.5%) compared to the placebo arm (65.8%).

In December 2011, Shire had submitted a marketing application seeking European approval of Vyvanse (under trade name Venvanse) for the treatment of children and adolescents aged between 6 and 17 years, who are diagnosed with ADHD.

Vyvanse is currently marketed for ADHD in children above 6 years, adolescents and adults in the US. The product is also marketed in the US as a maintenance treatment for ADHD in adults.

Shire is also evaluating the product for major depressive disorder (phase III) and negative symptoms of schizophrenia (phase II).

Our Take

Vyvanse, with $266.2 million revenues in the second quarter of 2012, is the top revenue grosser at Shire. As per data provided by IMS Health National Prescription Audit, Vyvanse enjoys a 16% share of the US ADHD market. In the second quarter of 2012, Vyvanse’s growth of 43% was significantly higher than the US ADHD market’s growth of 8%.

However, we note that competition in the US market is severe with generic versions of Johnson & Johnson's (JNJ - Analyst Report) Concerta and Novartis’ (NVS - Analyst Report) Ritalin available in the market. Moreover, in June 2012, the FDA approved the abbreviated new drug application (ANDA) filed by Actavis for its generic version of Adderall XR. Actavis is in the process of being acquired by Watson Pharmaceuticals Inc. .

Meanwhile, Shire is facing patent challenges for Vyvanse. Six companies, including Sandoz, Inc., the generic division of Novartis (NVS - Analyst Report), Amneal Pharmaceuticals LLC, Watson Laboratories, Roxane Laboratories, Inc., Mylan Pharmaceuticals, Inc. (MYL - Analyst Report) and Actavis have filed ANDAs for their generic versions of Vyvanse. Shire has filed patent infringement lawsuits against all these companies.

We currently have a Neutral recommendation on Shire. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

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