NEW YORK & BUDAPEST, Hungary--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for cariprazine, an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
In the complete response letter, the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed. "Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug", said Dr. Marco Taglietti, President, Forest Research Institute.
Dr. Taglietti further noted that "the unmet medical need for schizophrenia and bipolar disorder remains high. We are committed to pursuing novel treatment options like cariprazine to address patient needs. Forest and Gedeon Richter plan to meet with the FDA in the very near future to discuss the complete response letter and define a path forward."
Cariprazine, an investigational drug, is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients. Cariprazine is protected by a composition-of-matter patent that expires in 2027 without patent term extension.
Schizophrenia is a chronic and disabling disorder that affects more than 2 million people in the U.S. 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 disorder, which encompasses bipolar I and bipolar II disorders, affects approximately 5.7 million people in the U.S. 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. Patients experience "mood episodes" that 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.
About Gedeon Richter Plc.
Gedeon Richter Plc. 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 2.3 billion (USD 3.1 billion) in 2012. 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, respiratory, gastrointestinal and pain management medicine. Forest'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 Report 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.
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President – Investor Relations