Shire Announces Positive Topline Results of SHP465 Efficacy and Safety Study in Adults With ADHD

LEXINGTON, Massachusetts, June 29, 2016 /PRNewswire/ --

• Topline results revealed the study met its primary endpoints for both doses of SHP465 (12.5mg and 37.5mg) administered once daily, indicating superiority over placebo in ADHD symptom improvement (p<0.001).  
• Key secondary endpoint was also met for both doses showing significant improvement over placebo in patients' global functioning (p<0.001).  
• Study adds to the robust database of now 16 clinical studies enrolling more than 1,600 subjects in SHP465 clinical development program, positioning Shire to file a U.S. FDA resubmission by the end of 2016. 

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced positive topline results from a four-week randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration, efficacy and safety study, SHP465-306, in 275 adults aged 18-55 years with Attention-Deficit/Hyperactivity Disorder (ADHD). SHP465 (triple-bead mixed amphetamine salts - MAS) is an investigational oral stimulant medication being evaluated in the U.S. as a potential treatment for ADHD, a therapeutic area with significant need for additional treatment options.

The primary efficacy analysis of study 306 showed that SHP465 12.5mg and 37.5mg, both administered as a daily morning dose, were superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (ADHD-RS) total score, with Least Squares mean differences from placebo at Week 4 of -8.1 (95% CI: -11.7 to -4.4, p<0.001) for 12.5mg, and -13.3 (95% CI: -17.0 to -9.6, p<0.001) for 37.5mg. SHP465 12.5mg and 37.5mg doses were also significantly better than placebo on the key secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), at Week 4 of -0.8

(95% CI: -1.1 to -0.4, p<0.001) for 12.5mg, and -1.2 (95% CI: -1.6 to -0.9, p<0.001), suggesting a marked clinical improvement in patients' global functioning. The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication.

Treatment-emergent adverse events ≥ 5% for either dose of SHP465 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP465 studies and with other amphetamine compounds.

Matthew Brams, M.D., Clinical Assistant Professor at Baylor College of Medicine and principal investigator for study 306, added: "ADHD affects adults in multiple ways and, therefore, physicians need additional treatment options. Based upon this study's findings, and pending the U.S. FDA's review, SHP465 may provide a promising treatment option for physicians and patients alike."

"Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder," said Philip J. Vickers, Ph.D., Head of Research and Development at Shire. "We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD."

Shire plans to file a Class 2 Resubmission of the New Drug Application (NDA) with the U.S. Food and Drug Administration by the end of 2016; the program is on track for potential U.S. approval in the second half of 2017.  

Overall Robust SHP465 Clinical Development Program to Support Class 2 Resubmission  

Including study 306, Shire now has a robust database of 16 clinical studies evaluating more than 1,600 subjects in the SHP465 program.

Along with the pharmacokinetic study completed earlier this year, Shire plans to add these study results to its existing SHP465 data set to submit a Class 2 resubmission for FDA approval of the medicine for the treatment of ADHD.

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. With a launch planned for the second half of 2017, Shire expects that SHP465, following potential FDA approval, 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.

About ADHD in Adults 

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% 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 healthcare 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.

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, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

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

Forward-Looking Statements 

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

• disruption from the acquisition and integration of Baxalta Incorporated ("Baxalta") may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;
• the company may not achieve some or all of the anticipated benefits of Baxalta's spin-off from Baxter International, Inc. ("Baxter") and the acquisition may have an adverse impact on Baxalta's existing arrangements with Baxter, including those related to transition, manufacturing and supply services and tax matters;
• the failure to achieve the strategic objectives with respect to the acquisition of Baxalta may adversely affect the company's financial condition and results of operations;
• products and product candidates may not achieve commercial success;
• product sales from ADDERALL XR and INTUNIV are subject to generic competition;
• the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the company's products may affect future revenues, financial condition and results of operations, particularly if there is pressure on pricing of products to treat rare diseases;
• supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors; regulatory actions associated with product approvals or changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
• the actions of certain customers could affect the company's ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the company's revenues, financial condition or results of operations;
• investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the company's activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
• adverse outcomes in legal matters, tax audits and other disputes, including the company's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the company's revenues, financial condition or results of operations;
• Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect the company's ability to attract and/or retain the highly skilled personnel needed to meet its strategic objectives;
• failure to achieve the strategic objectives with respect to Shire's acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. ("Dyax") may adversely affect the company's financial condition and results of operations;
• the company is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on the company's revenues, financial condition or results of operations;
• the company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners;
• difficulties in integrating Dyax or Baxalta into Shire may lead to the company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and
• other risks and uncertainties detailed from time to time in Shire's, Dyax's or Baxalta's filings with the Securities and Exchange Commission, including those risks outlined in "ITEM 1A: Risk Factors" in Shire's and Baxalta's Annual Reports on Form 10-K for the year ended December 31, 2015.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

For further information please contact:

Investor Relations        
Sarah Elton-Farr, [email protected] , +44-1256-894157
Ian Karp, [email protected], +1-781-482-9018
Robert Coates, [email protected], +44-1256-894874

Media        
Gwen Fisher, [email protected], +1-781-482-9649
Charlie Catalano, [email protected], +1-781-266-3568

SOURCE Shire plc

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