Forest Laboratories, Inc. to Present Cariprazine Data at the International College of Neuropsychopharmacology World Congress
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) today announced that data on the investigational drug cariprazine will be presented at the International College of Neuropsychopharmacology (CINP) 29th World Congress, scheduled June 22-26, 2014 in Vancouver, Canada.
Mon. June 23, 5:15-6:45 PM PDT:
- Cariprazine Monotherapy in the Treatment of Bipolar Depression: A Double-Blind, Placebo-Controlled Study (poster #LP-01-005)
- Categorical Improvements in Severity of Mania and Schizophrenia Symptoms: Pooled Analyses of Cariprazine Phase II/III Trials (poster #P-03-014)
- Cariprazine Demonstrates Greater Potency Than Aripiprazole In Animal Models of Psychosis, Cognitive Impairment, and Negative Symptoms (poster #P-05-009)
- Safety and Tolerability of Cariprazine in Long-Term Treatment of Schizophrenia: Integrated Summary of Safety Data (poster #P-05-027)
Tues. June 24, 5:15-6:45 PM PDT:
- Cariprazine as Adjunctive Therapy in Major Depressive Disorder: A Double-Blind, Placebo-Controlled Study (poster #LP-02-009)
Wed. June 25, 5:15-6:45 PM PDT:
- Safety and Tolerability of Cariprazine in Patients with Acute Bipolar Mania: Pooled Analysis of 3 Phase II/III Pivotal Studies (poster #P-41-011)
Cariprazine, an investigational drug, is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist atypical antipsychotic. It has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic receptor sites. Cariprazine is protected by a composition-of-matter patent that expires in 2027 without patent term extension.
Cariprazine is being developed for the treatment of schizophrenia and bipolar mania in adults. On November 21, 2013 Gedeon Richter Plc. and Forest announced that the U.S. Food and Drug Administration issued a complete response letter regarding the new drug application for schizophrenia and bipolar mania. In addition, cariprazine is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
Cariprazine was discovered by Gedeon Richter Plc. and is licensed to Forest Laboratories, Inc., in the U.S. and Canada.
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. Depression that occurs in patients with bipolar disorder is called “bipolar depression.”
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest’s strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.
Forest 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.