WALTHAM, Mass., March 31 /PRNewswire-FirstCall/ -- Repligen Corporation announced today that it has exclusively licensed worldwide rights for the use of uridine in the treatment of patients with bipolar disorder from McLean Hospital. The use of uridine in the treatment of patients with bipolar disorder is currently the subject of a patent application and upon issue, the patent will remain in force until 2025 prior to any regulatory extensions. Under the terms of the license agreement, McLean will receive an upfront payment, development milestones and royalties upon successful commercialization of uridine for bipolar disorder. McLean Hospital is the largest psychiatric facility of Harvard Medical School and maintains the largest research program of any private, U.S. psychiatric hospital. Repligen is developing RG2417, an oral formulation of uridine, as a treatment for the depressive symptoms of bipolar disorder based on positive results of a previously reported Phase 2a clinical trial.
“Bipolar disorder affects more than two million adults in the United States,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “Treatment of the symptoms of bipolar depression remains an area of significant unmet medical need, as current therapies are ineffective and result in numerous side effects. We look forward to completion of our ongoing proof-of-concept clinical trial which could provide a new approach to the treatment of bipolar depression.”
Repligen is currently conducting a Phase 2b clinical trial of RG2417 designed to confirm and extend the positive results obtained in a Phase 2a clinical trial which demonstrated that RG2417 was well tolerated and resulted in a statistically significant improvement in the symptoms of bipolar depression over the six-week treatment period compared to placebo. The ongoing Phase 2b clinical trial is a randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or placebo twice daily for eight weeks. This study is designed to assess the safety and impact of RG2417 on the symptoms of bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Depression Scale (CGI-BP-C). This study is being conducted at approximately 20 clinical sites within the United States.
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 and depression. 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 $600,000 per patient, depending on resistance to treatment and persistence of symptoms. Although several therapies are approved for the treatment 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 McLean Hospital
McLean Hospital maintains the largest research program of any private, U.S. psychiatric hospital. It is the largest psychiatric facility of Harvard Medical School, an affiliate of Massachusetts General Hospital and a member of Partners HealthCare. For additional information, please visit www.mclean.harvard.edu.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we are the world’s leading supplier of recombinant Protein A, the sales of which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen’s corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from 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.
CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer,
+1-781-419-1900, or Laura Whitehouse, Vice President, Market Development,
+1-781-419-1812, both of Repligen Corporation
Web site: http://www.repligen.com/
