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Shire, Shionogi File NDA for Intuniv for Adults in Japan
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Shire Plc. announced that its Japanese partner Shionogi & Co., Ltd submitted a new drug application (NDA) for the manufacture and marketing of Intuniv (guanfacine hydrochloride extended release) in Japan for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. Intuniv is being co-developed and commercialized by Shire and Shionogi under a licensing contract signed in 2011.
Intuniv, is a non-stimulant, selective alpha-2A adrenergic receptor agonist, which is approved in Japan since March 2017, for the treatment for child and adolescent patients (6 to 17 years old) with ADHD. Intuniv is also approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) as adjunctive therapy to stimulants for the treatment of ADHD in children and adolescents aged 6 to 17.
The NDA in Japan was filed on the basis of top-line results from a phase III study in adults, which showed that Intuniv (4 to 6mg), administered once daily, met its primary endpoint demonstrating superiority over placebo in the improvement of ADHD symptoms. Results also showed statistically significant improvement over placebo in patients’ global functioning.
Shire’s shares have outperformed the industry so far this year, rising 10% compared with the industry’s 1.1% gain.
Shire is a leader in the ADHD market with drugs like Vyvanse, Adderall XR and Intuniv. The adult ADHD space is one of the largest and fastest growing segments of the market and approval of new drugs will further strengthen Shire’s dominance. However, Shire faces competition from branded stimulants in the ADHD segment in the United States from Johnson & Johnson’s (JNJ - Free Report) Concerta and Pfizer Inc.’s (PFE - Free Report) Quillivant.
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 7.2% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Shire, Shionogi File NDA for Intuniv for Adults in Japan
Shire Plc. announced that its Japanese partner Shionogi & Co., Ltd submitted a new drug application (NDA) for the manufacture and marketing of Intuniv (guanfacine hydrochloride extended release) in Japan for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. Intuniv is being co-developed and commercialized by Shire and Shionogi under a licensing contract signed in 2011.
Intuniv, is a non-stimulant, selective alpha-2A adrenergic receptor agonist, which is approved in Japan since March 2017, for the treatment for child and adolescent patients (6 to 17 years old) with ADHD. Intuniv is also approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) as adjunctive therapy to stimulants for the treatment of ADHD in children and adolescents aged 6 to 17.
The NDA in Japan was filed on the basis of top-line results from a phase III study in adults, which showed that Intuniv (4 to 6mg), administered once daily, met its primary endpoint demonstrating superiority over placebo in the improvement of ADHD symptoms. Results also showed statistically significant improvement over placebo in patients’ global functioning.
Shire’s shares have outperformed the industry so far this year, rising 10% compared with the industry’s 1.1% gain.
Shire is a leader in the ADHD market with drugs like Vyvanse, Adderall XR and Intuniv. The adult ADHD space is one of the largest and fastest growing segments of the market and approval of new drugs will further strengthen Shire’s dominance. However, Shire faces competition from branded stimulants in the ADHD segment in the United States from Johnson & Johnson’s (JNJ - Free Report) Concerta and Pfizer Inc.’s (PFE - Free Report) Quillivant.
Shire plc Price
Shire plc Price | Shire plc Quote
Zacks Rank & Stocks to Consider
Shire has a Zacks Rank #3 (Hold).
A better-ranked stock from the same space worth considering is Gilead Sciences Inc. (GILD - Free Report) carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 7.2% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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