U.S. FDA Acknowledges Receipt of Shire's New Drug Application for SHP465 for ADHD

LEXINGTON, Massachusetts, January 19, 2017 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

"Our progress with the SHP465 clinical development program underscores Shire's commitment to supporting the needs of patients living with ADHD in the U.S.," said Philip Vickers, PhD, Global Head of Research and Development, Shire. "Since our first submission, our understanding of ADHD and adult patients' needs has evolved, and we believe the additional studies in our filing fulfill the request from the FDA. With the potential of once-daily dosing, SHP465, if approved, could help patients address the ongoing challenges of ADHD symptoms."

"As the medical community broadens its understanding of ADHD and the ways it impacts people differently, it is important to expand the long-acting treatment options available to health care professionals to address patient needs," said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the SHP465 clinical trials. "It's encouraging to see that health care professionals and their patients living with ADHD may have more options available to them."

The NDA for SHP465 includes data from a database of 16 clinical studies evaluating SHP465 in more than 1,600 subjects, including data resulting from a U.S. FDA request to conduct a short-term efficacy and safety study in pediatric patients with ADHD (aged 6-17). Positive top-line results from that study, SHP465-305, were reported in April 2016. 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.

In earlier adolescent and adult clinical studies, SHP465 demonstrated a statistically significant difference versus placebo at 16 hours post-dosing, with onset of action starting 2 or 4 hours post-dosing, as measured by the Permanent Product Measure of Performance (PERMP). PERMP is an objective, validated, skill-adjusted math test that measures attention in ADHD. The most common adverse reactions in Phase 3 studies (incidence ≥5% and at a rate at least twice placebo) in children, adolescents, and/or adults with ADHD were insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, anxiety, nausea, upper abdominal pain, irritability and dizziness.

Protection for Shire's ADHD Franchise Extends to 2029 

There are patents supporting Shire's overall ADHD franchise in the U.S. that extend to 2029. If approved, Shire expects that SHP465 will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029. Launch is planned for the second half of 2017.

About ADHD 

Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.

An estimated 4.4 percent of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD in the U.S.

The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5^®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification and/or medication. Ongoing assessment and treatment may be necessary.

DSM-5^® is a registered trademark of the American Psychiatric Association.

NOTES TO EDITORS 

About Shire 

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

http://www.shire.com

For further information please contact: 

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