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.
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