Forest Laboratories, Inc., (NYSE: FRX) and Gedeon Richter Plc. announced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada.
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).
About Bipolar I Disorder
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.
Cariprazine is an orally active and potent dopamine D3-preferring D3/D2 receptor partial agonist. Cariprazine has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic which have been associated with adverse events.
About Gedeon Richter Plc.
Gedeon Richter Plc. (www.richter.hu) headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter’s consolidated sales were approximately EUR 1.1 billion (USD 1.5 billion) while its market capitalization amounted to EUR 2.1 billion (USD 2.7 billion) in 2011. The product portfolio of the Company covers almost all important therapeutic areas, including gynecology, central nervous system and cardiovascular. Having the largest R&D unit in Central Eastern Europe, the Company’s original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise Richter is a significant player in the female healthcare field worldwide. Richter is also active in the scope of biosimilar product development.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory, gastrointestinal, and pain management medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
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.