For Immediate Release
Chicago, IL – September 18, 2012 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Shire plc (SHPG - Analyst Report), Johnson & Johnson (JNJ - Analyst Report), Novartis (NVS - Analyst Report), Watson Pharmaceuticals Inc. and Mylan Pharmaceuticals, Inc. (MYL - Analyst Report).
Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513
Here are highlights from Monday’s Analyst Blog:
Shire to Expand Vyvanse Label
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).
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.
Want more from Zacks Equity Research? Subscribe to the free Profit from the Pros newsletter: http://at.zacks.com/?id=5515.
About Zacks Equity Research
Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.
Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.
Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today: http://at.zacks.com/?id=5517
Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1978 by Leon Zacks. As a PhD from MIT Len knew he could find patterns in stock market data that would lead to superior investment results. Amongst his many accomplishments was the formation of his proprietary stock picking system; the Zacks Rank, which continues to outperform the market by nearly a 3 to 1 margin. The best way to unlock the profitable stock recommendations and market insights of Zacks Investment Research is through our free daily email newsletter; Profit from the Pros. In short, it's your steady flow of Profitable ideas GUARANTEED to be worth your time! Register for your free subscription to Profit from the Pros at http://at.zacks.com/?id=5518.
Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.
Follow us on Twitter: http://twitter.com/zacksresearch
Join us on Facebook: http://www.facebook.com/home.php#/pages/Zacks-Investment-Research/57553657748?ref=ts
Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.
Zacks Investment Research
800-767-3771 ext. 9339