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Shire's (SHPG) ADHD Candidate's NDA Accepted by FDA

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Shire plc announced that the FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for pipeline candidate, SHP465.

Shire’s shares have performed better the Zacks classified Medical-Drugs industry in the last twelve months. The stock lost 7.4% in the last twelve months which compared favorably to the industry’s 10.8% decline.



The candidate is being evaluated as a once-daily treatment for Attention-Deficit/Hyperactivity Disorder .

The FDA is expected to give a decision by June 20, 2017.

We remind investors that Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007). The original NDA was submitted in 2006.

The letter requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

There has been a surge in adult ADHD population and hence Shire expects a greater commercial need for the candidate than in 2006.The candidate provide an extended-release of amphetamines to provide coverage of ADHD symptoms for adults.  
 
The NDA for SHP465 includes data from a database of 16 clinical studies evaluating SHP465 in more than 1,600 subjects. The NDA also includes data from a short-term efficacy and safety study in pediatric patients with ADHD (aged 6-17) which was conducted as per the FDA’s requirement.

We note that Shire announced positive top-line from a four-week phase III randomized, double-blind, multi-center, placebo-controlled, dose-optimization, safety and efficacy study in children and adolescents aged 6-17 years with ADHD in Apr 2016.  The results from the study showed SHP465, administered as a daily morning dose, was superior to placebo on the change from baseline in ADHD-RS-IV (ADHD rating scale) total score. SHP465 was also superior to placebo in the key secondary efficacy analysis on the CGI-I scale.

In addition, Shire also successfully completed a required PK study of SHP465in Apr 2016. The PK properties of SHP465 were well characterized in children and adolescents aged 6 to 17 years with ADHD and confirmed the exposure necessary for once daily oral dosing. The NDA also includes results from SHP465-306, a short-term efficacy study in adults, for which positive top-line results were announced in June 2016.

Assuming approval, Shire will have will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book which are slated to expire as late as May 2029.

Shire is planning to launch the candidate in the second half of 2017.

Shire is a leader in the ADHD market with drugs like Vyvanse and Intuniv. The adult ADHD space is one of the largest and fastest growing segments and a potential approval of SHP465 will further strengthen Shire’s franchise.

Earlier in the week, shares of Alcobra Ltd.   declined significantly after the company reported disappointing top-line results from a phase III study, MEASURE, on experimental candidate metadoxine, extended release (MDX) for the treatment of ADHD in adult patients.

Shire PLC Price and Consensus

 

Shire PLC Price and Consensus | Shire PLC Quote

Zacks Rank & Key Picks

Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) and ARIAD Pharmaceuticals, Inc . Both these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 36% in the last twelve months.

ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 45 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.

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