WALTHAM, Mass., April 30 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today that the United States Patent and Trademark Office has granted a Notice of Allowance of a patent covering the use of uridine in the treatment of patients with bipolar disorder. The patent, which upon issue will remain in force until 2025 prior to any patent term extensions, covers the use of an effective dose of a uridine composition to improve one or more of the symptoms of bipolar disorder including depression, mania, mixed episodes, hypomania and anxiety. Repligen is currently enrolling patients in a Phase 2b clinical trial of RG2417, an oral formulation of uridine, to assess its impact on the symptoms of acute depression. This study is designed to confirm and extend the results of a Phase 2a study in which 6 weeks of treatment with RG2417 improved the symptoms of bipolar depression when compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale. Repligen has exclusively licensed this patent from McLean Hospital, the largest psychiatric facility of Harvard Medical School.
"We are very pleased with this action by the United States Patent Office covering the use of a potentially important new treatment for bipolar disorder," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "This patent will provide commercial exclusivity for RG2417 in the United States through at least 2025."
This patent may qualify for up to 5 years of patent term extension under the provisions of the Hatch-Waxman Act, subject to certain limitations. Foreign equivalents of this patent as well as related patent applications are still pending and if granted would provide further market protection for RG2417.
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 neurological disorders. 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, including trials utilizing RG2417 or other forms of uridine in the treatment of bipolar disorder, and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, including statements regarding the commercial exclusivity provided by the patent covering the use of uridine in the treatment of patients with bipolar disorder discussed in this press release, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets, including the market for RG2417 or other forms of uridine, 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.
SOURCE Repligen Corporation
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"We are very pleased with this action by the United States Patent Office covering the use of a potentially important new treatment for bipolar disorder," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "This patent will provide commercial exclusivity for RG2417 in the United States through at least 2025."
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This patent may qualify for up to 5 years of patent term extension under the provisions of the Hatch-Waxman Act, subject to certain limitations. Foreign equivalents of this patent as well as related patent applications are still pending and if granted would provide further market protection for RG2417.
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 neurological disorders. 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, including trials utilizing RG2417 or other forms of uridine in the treatment of bipolar disorder, and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, including statements regarding the commercial exclusivity provided by the patent covering the use of uridine in the treatment of patients with bipolar disorder discussed in this press release, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets, including the market for RG2417 or other forms of uridine, 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.
SOURCE Repligen Corporation
