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Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder

DUBLIN, March 13, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Saphris (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17). Saphris is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation.

Approximately 1.2 million children and teens in the United States meet the criteria for bipolar I disorder. Patients with bipolar I disorder experience "mood episodes" ranging from manic episodes, depressive episodes, or mixed episodes (a combination of both mania and depression). Often, younger patients with bipolar I disorder experience more frequent mood episodes.

"We were pleased to see that Saphris was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder," said David Nicholson, Executive Vice President Global R&D at Actavis. "Saphris is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."

 

The FDA approval of Saphris is based on the results of a 3-week monotherapy trial in 403 pediatric patients (ages 10 – 17), of which 302 pediatric patients received Saphris twice daily in doses of either 2.5 mg, 5 mg or 10 mg.

Saphris was shown to demonstrate improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score versus placebo in a pediatric clinical trial.

"Bipolar I disorder in children and teens is a significant public health problem in the U.S. The diagnosis and recognition of bipolar I disorder in children and teens continues to rise, and this illness can often be more severe in pediatric patients than adults," said Kiki Chang, MD, Professor of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Division of Child Psychiatry. "The FDA approval of this pediatric indication for Saphris is very important because it provides an additional treatment option for children and teens affected by this complex condition."

In the pediatric clinical trial the most common side effects that occurred with Saphris were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Saphris will be available for pediatric patients with bipolar I disorder in 2.5 mg, 5 mg and 10 mg black cherry flavor sublingual tablets in Q2 2015.

About Actavis plc

Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory, and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.Actavis.com.

Actavis Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

SOURCE Actavis plc

Posted: March 2015

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