WALTHAM, Mass., Oct. 21 /PRNewswire-FirstCall/ -- Repligen Corporation today announced that the Company has entered into an expanded development agreement with the Stanley Medical Research Institute under which Repligen will receive approximately $1,000,000 in funding for a Phase 2 clinical trial of uridine in bipolar depression. Pending approval by the FDA, the Phase 2 study will be a multi-center, dose escalating study in which 80 patients will receive either an oral formulation of uridine or a placebo for 6 weeks. Patients will be evaluated for the safety and effectiveness of uridine on the symptoms of bipolar depression. The Stanley Medical Research Institute is the largest nonprofit provider of funding for research on schizophrenia and bipolar disorder in the United States.
“We are very pleased to receive additional support for our uridine program from The Stanley Medical Research Institute, a world leader in the support and development of new drugs for bipolar disorder and schizophrenia,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. “This study has the potential to provide proof of concept for uridine in bipolar depression.”
“Bipolar depression is difficult to treat, where one of the greatest challenges has been the induction of mania in patients receiving treatment with standard antidepressants,” stated Dr. Mike Knable, Executive Director of The Stanley Medical Research Institute. “If uridine improves the symptoms of bipolar depression without inducing mania, it has the potential to be an important new therapy.”
In 2004, Repligen completed a 6-week Phase 1 clinical trial of a prodrug of a uridine (RG2133) in patients with bipolar disorder or major depression. The results demonstrated that administration of RG2133 in this patient population appeared to be safe, did not induce mania, a potential side effect of existing therapies, and provided early evidence of a clinical effect of the drug. The trial evaluated 19 patients and was carried out by investigators at McLean Hospital, the largest psychiatric clinical care, teaching and research affiliate of Harvard Medical School.
Uridine is a biological compound essential for the synthesis of DNA and RNA, the basic hereditary material found in all cells, and numerous other factors essential for cell metabolism. Uridine is synthesized by the power plant of the human cell known as the mitochondria. The rationale for uridine therapy in neuropsychiatric disorders is supported by pre-clinical and clinical research. Researchers at McLean Hospital previously demonstrated that uridine is active in a well-validated animal model of depression. Recent reports indicate that certain genes that encode for mitochondrial proteins are significantly down-regulated in the brains of bipolar patients. This new insight suggests that the symptoms of bipolar disorder may be linked to dysregulation of energy metabolism of the brain.
About Bipolar Disorder
Bipolar disorder, also known as manic depression is an illness marked by extreme changes in mood, thought, energy and behavior in which a person’s mood can alternate between the “poles” of mania (highs) and depression (lows). Bipolar disorder affects more than two million adults in the United States and is usually diagnosed in late adolescence or early adulthood. Bipolar disorder is a chronic illness associated with substantial morbidity and mortality, ranking worldwide behind only unipolar depression and alcohol abuse among psychiatric illnesses for related disabilities and overall economic burden of illness. The lifetime financial burden of bipolar disorder in the United States is about $625,000 per patient, depending on resistance to treatment and persistence of symptoms. Although lithium and anticonvulsants such as valproic acid have substantially improved the prognosis of bipolar disorder, many individuals are unable to tolerate treatment-related side effects, and incomplete clinical response, relapse, and recurrence remain common clinical problems.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute (SMRI) is a nonprofit organization that supports research on the causes and treatment of schizophrenia and bipolar disorder (manic-depressive illness), both through work carried out in its own laboratories and through support of researchers worldwide who are working on these diseases. SMRI is the largest nonprofit provider of research funding for schizophrenia and bipolar disorder in the United States and has provided over $200 million in funding since 1999. SMRI funds approximately half of all U.S. research on bipolar disorder and approximately one quarter of the research on schizophrenia. Schizophrenia and bipolar disorder are the major psychiatric disorders in the United States, affecting more than 4 million people.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of novel therapeutics for profound neuropsychiatric disorders and autoimmune disease. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(R), the profits from which will be used to partially support the development of our proprietary products. Repligen’s corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://www.repligen.com.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management’s strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen’s filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
Repligen Corporation
CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer,+1-781-250-0111, ext. 2000, or Laura Whitehouse, Vice President, MarketDevelopment, +1-781-250-0111, ext. 2306, both of Repligen Corporation
Web site: http://www.repligen.com//
