WALTHAM, Mass., Oct. 6 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today announced the initiation of a follow-on study to assess
the impact of RG1068, synthetic human secretin, on a surrogate marker for a
cognitive deficit characteristic of patients with schizophrenia. This study
is being conducted to determine if the preliminary finding that secretin may
have had an impact on a cognitive deficit in schizophrenia is reproducible and
related to drug treatment. This is an investigator initiated study conducted
by Indiana University Hospital School of Medicine.
"This study will determine if the preliminary observations made in our
Phase 2 study in schizophrenia are reproducible," stated Walter C. Herlihy,
President and Chief Executive Officer, Repligen Corporation. "There are
currently no drugs approved for the treatment of the cognitive deficits in
schizophrenia, an area of significant unmet medical need in the United
States."
Thirty patients will be assigned to one of two double blind treatment
groups, subcutaneous saline or subcutaneous RG1068. Additional assessments
will be made on the patients to investigate the effects of RG1068 on
information processing and affect modulation.
About Schizophrenia
Schizophrenia is a serious and chronic neuropsychiatric disorder that
affects 2 million people in the United States. Deficits in cognition are
present at all stages of the disease, contribute to the rate of relapse and
are predictive of long-term outcome. Current treatment with antipsychotic
therapy is generally directed at control of positive symptoms. Even when
successful, antipsychotic therapy has limited impact on the severe, residual
and often incapacitating cognitive deficits of schizophrenia. Sales in the
United States of antipsychotic drugs for schizophrenia including Zyprexa(TM),
Risperdal(TM) and Geodon(TM) exceed $5 billion and the total cost for the care
and treatment of patients is approximately $40 billion.
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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