WALTHAM, Mass., Oct. 21 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today announced that the Company has entered into an expanded
development agreement with the Stanley Medical Research Institute under which
Repligen will receive approximately $1,000,000 in funding for a Phase 2
clinical trial of uridine in bipolar depression. Pending approval by the FDA,
the Phase 2 study will be a multi-center, dose escalating study in which 80
patients will receive either an oral formulation of uridine or a placebo for 6
weeks. Patients will be evaluated for the safety and effectiveness of uridine
on the symptoms of bipolar depression. The Stanley Medical Research Institute
is the largest nonprofit provider of funding for research on schizophrenia and
bipolar disorder in the United States.
"We are very pleased to receive additional support for our uridine program
from The Stanley Medical Research Institute, a world leader in the support and
development of new drugs for bipolar disorder and schizophrenia," stated
Walter C. Herlihy, President and Chief Executive Officer of Repligen. "This
study has the potential to provide proof of concept for uridine in bipolar
depression."
"Bipolar depression is difficult to treat, where one of the greatest
challenges has been the induction of mania in patients receiving treatment
with standard antidepressants," stated Dr. Mike Knable, Executive Director of
The Stanley Medical Research Institute. "If uridine improves the symptoms of
bipolar depression without inducing mania, it has the potential to be an
important new therapy."
In 2004, Repligen completed a 6-week Phase 1 clinical trial of a prodrug
of a uridine (RG2133) in patients with bipolar disorder or major depression.
The results demonstrated that administration of RG2133 in this patient
population appeared to be safe, did not induce mania, a potential side effect
of existing therapies, and provided early evidence of a clinical effect of the
drug. The trial evaluated 19 patients and was carried out by investigators at
McLean Hospital, the largest psychiatric clinical care, teaching and research
affiliate of Harvard Medical School.
Uridine is a biological compound essential for the synthesis of DNA and
RNA, the basic hereditary material found in all cells, and numerous other
factors essential for cell metabolism. Uridine is synthesized by the power
plant of the human cell known as the mitochondria. The rationale for uridine
therapy in neuropsychiatric disorders is supported by pre-clinical and
clinical research. Researchers at McLean Hospital previously demonstrated
that uridine is active in a well-validated animal model of depression. Recent
reports indicate that certain genes that encode for mitochondrial proteins are
significantly down-regulated in the brains of bipolar patients. This new
insight suggests that the symptoms of bipolar disorder may be linked to
dysregulation of energy metabolism of the brain.
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 (highs) and depression (lows).
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 1999. SMRI funds approximately
half of all U.S. research on bipolar disorder and approximately one quarter of
the research on schizophrenia. Schizophrenia and bipolar disorder are the
major psychiatric disorders in the United States, affecting more than 4
million people.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the
leader in the development of novel therapeutics for profound neuropsychiatric
disorders and autoimmune disease. Repligen has a Specialty Pharmaceuticals
business comprised of rProtein A(TM) and SecreFlo(R), the profits from which
will be used to partially support the development of our proprietary products.
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, +1-781-250-0111, ext. 2000, or Laura
Whitehouse, Vice President, Market Development, +1-781-250-0111,
ext. 2306, both of Repligen Corporation
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