WALTHAM, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today announced positive results from a Phase 2a clinical
trial of RG2417, an oral formulation of uridine, in patients with bipolar
disorder. This was a multi-center study in which 84 patients received
either RG2417 or a placebo twice a day for six-weeks. Patients in the
RG2417 and placebo groups were well matched in their symptoms at baseline
with the exception of mania for which the RG2417 group mania score was
significantly higher (p=0.01). The objective of the study was to assess the
safety and efficacy of RG2417 on the symptoms of bipolar depression as
measured by the co-primary endpoints, the Montgomery-Asberg Depression
Rating Scale (MADRS) and the Clinical Global Impression of Change in
Bipolar Disorder scale (CGI-BP-C). Patients were evaluated at baseline and
then weekly using these standardized tools to assess change in their
symptoms. Over the six-week treatment period, the study demonstrated a
statistically significant improvement in the symptoms of depression in the
patients receiving RG2417 when compared to placebo on the MADRS (p=0.03)
and a strong trend toward improvement on the CGI-BP-C (p=0.06).
Secondary observations from the study included a statistically
significant decrease in mania score as determined using the Young Mania
Rating Scale (YMRS) for mania (p=0.01), in the patients receiving RG2417
over the aggregate six-week treatment period when compared to placebo.
Preliminary 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.
"We are pleased with the results of this study which provides
substantial evidence of efficacy of RG2417 in improving the symptoms of
bipolar disorder," stated Walter C. Herlihy, President and Chief Executive
Officer of Repligen Corporation. "The results of this study support further
evaluation of RG2417 in this patient population and will be useful in the
design of future clinical studies."
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 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.
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com
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
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