Repligen Announces Plans To Initiate A Phase 2b Trial For RG2417 In Bipolar Disorder

Repligen Corporation
(Nasdaq: RGEN) announced that based on feedback from the Food and
Drug Administration, the Company plans to initiate a Phase 2b clinical
trial of RG2417, an oral formulation of uridine, in patients with bipolar
disorder later this year. This will be a multi-center, parallel arm
placebo-controlled, clinical trial in which approximately 150 patients with
bipolar disorder will receive either RG2417 or a placebo twice a day for
eight-weeks. This study is designed to assess the efficacy and safety of
RG2417 on the symptom of depression as measured by the Montgomery-Asberg
Depression Rating Scale (MADRS). Gary S. Sachs, M.D., founder and director
of the Bipolar Clinic and Research Program at the Massachusetts General
Hospital and an Associate Professor of Psychiatry at the Harvard Medical
School will be the Principal Investigator of this study.



Repligen previously reported positive initial results from a Phase 2a
clinical trial of RG2417 in patients with bipolar disorder. We have now
completed our assessment of the data and have found that patients with a
history of more frequent symptoms demonstrated greater improvements when
treated with RG2417 than patients without a history of frequent symptoms.
For example, patients with more than 5 episodes of depression over their
entire life (n=50) demonstrated greater improvements in their symptoms of
depression compared to patients with 5 or fewer lifetime episodes of
depression. From weeks 2-6 of treatment, the patients with more than 5
lifetime episodes of depression who received RG2417 had an average
improvement on MADRS of 5.5 points over placebo (p








A complete review of the data suggests that RG2417 was well tolerated.
This study was conducted under a development agreement with the Stanley
Medical Research Institute, the largest nonprofit provider of funding for
research on schizophrenia and bipolar disorder in 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 $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 1989.



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 repligen.



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with respect to the announcements described herein.


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