EXHIBIT 99.1
RepliGen Repligen Corporation
41 Seyon Street
Building #1, Suite 100
Waltham, Massachusetts 02453
Telephone: 781-250-0111
Telefax: 781-250-0115
FOR IMMEDIATE RELEASE
CONTACT:
Walter C. Herlihy, Ph.D. David A. Walsey
President and Chief Executive Officer The Ruth Group
(781) 250-0111, ext. 2000 (646) 536-7029
Repligen Announces District Court Decision in CTLA4-Ig Patent Suit
University of Michigan Scientist Not Named an Inventor
WALTHAM, MA - September 16, 2003 - Repligen Corporation (Nasdaq: RGEN) announced
today that the United States District Court for the Eastern District of Michigan
has issued a ruling in the lawsuit that Repligen and The University of Michigan
(the "University") are prosecuting against Bristol-Myers Squibb (NYSE:BMY) for
correction of inventorship of certain CTLA4 patents issued to Bristol-Myers
Squibb ("Bristol"). The Court ruled that there was insufficient evidence for the
University scientist to be named as an inventor on these patents. Separately,
Repligen announced today that is has received a Notice of Allowance from the
United States Patent and Trademark Office on a patent which claims the use of
CTLA4-Ig for treatment of rheumatoid arthritis, multiple sclerosis and systemic
lupus erythematosis. This allowed patent is separate from the patents on
CTLA4-Ig which are the subject of the Court's ruling.
"Although we are disappointed in the Court's ruling, we would like to thank the
judge for his diligence in this complex case," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen. "We continue to believe that
the University scientist made significant inventive contributions in discovering
the activity of CTLA4-Ig and will accordingly consider all appropriate options,
including appeal."
CTLA4-Ig Inventorship Trial
CTLA4 is a T-cell regulatory protein which is one of the immune system's natural
"off switches", which may have potential use in organ transplantation and
autoimmune diseases. Repligen is the exclusive licensee of all CTLA4-Ig patent
rights owned by the University of Michigan. Repligen and the University believe
that the University has a rightful claim to ownership of certain patents of
Bristol-Myers Squibb which relate to compositions and uses of CTLA4, arising out
of the inventive contributions by one of the University's scientists. Repligen
and the University filed a complaint against Bristol in the United States
District Court for the Eastern District of Michigan seeking a correction of
inventorship. The suit asserts that Dr. Craig Thompson, the scientist from the
University, made inventive contributions as part of a collaboration with Bristol
scientists and is therefore a rightful inventor on patents issued to Bristol.
Repligen's failure to obtain ownership rights to the Bristol patents may
restrict Repligen's ability to commercialize CTLA4-Ig.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the
leader in the development of new drugs for pediatric developmental disorders
including autism, immune and metabolic disorders. Repligen has a Specialty
Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(TM), the
profits from which will be used to support the development of our proprietary
products. rProtein A(TM) is a consumable reagent used by the pharmaceutical
industry to produce a class of drugs called monoclonal antibodies and
SecreFlo(TM), secretin for injection, is marketed to gastroenterologists for
pancreatic assessment and for use during a gastrointestinal procedure called
ERCP. Repligen's corporate headquarters are located at 41 Seyon Street, Building
#1, Suite 100, Waltham, MA 02453. Additional information may be requested from
www.repligen.com.
This release contains forward-looking statements which are made pursuant to the
safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
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,
management's strategy, plans and objectives for future operations, clinical
trials and results and product development and manufacturing plans and
performance such as the anticipated growth in the monoclonal antibody market 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.
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