Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with Bipolar I Disorder

The application for the treatment of schizophrenia includes results from three positive trials in over 1700 patients, two fixed dose studies with active controls and one fixed-flexible placebo-controlled dose study using the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score as primary efficacy endpoint.

The application for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder includes results from three positive placebo-controlled trials in over 1000 patients, two flexible dose studies and one fixed-flexible dose study using the change from baseline in the Young Mania Rating Scale (YMRS) total score as primary efficacy endpoint.

In the schizophrenia and bipolar mania pivotal trials, cariprazine was generally well tolerated. The most commonly reported adverse reactions (≥5% and twice placebo), which were predominantly mild to moderate in severity, were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue and vomiting.

Schizophrenia is a chronic and disabling disorder that affects more than 2 million American adults. It imposes significant burden on patients, their families, and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders, and movement disorders), negative symptoms (such as loss of motivation and social withdrawal), and cognitive symptoms (problems with executive functioning, focusing, and working memory).

Bipolar I disorder, also known as manic-depressive illness, is characterized by unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. It affects more than 5.7 million American adults. Patients experience “mood episodes” which manifest as either a manic episode (overexcited, extreme irritability, racing thoughts, and difficulties with sleep) or a depressive episode (extreme sadness, fatigue or hopelessness) or a combination of both.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward looking statements contained in this release to reflect new information or future events or developments.