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 Allowed Patent for Treatment of Rheumatoid Arthritis with CTLA4-Ig
WALTHAM, MA - September 16, 2003 - Repligen Corporation (Nasdaq: RGEN) announced
today that it has received a Notice of Allowance from the United States Patent
and Trademark Office for a patent covering the use of CTLA4-Ig for the treatment
of rheumatoid arthritis. The patent, which will remain in force until 2020, also
covers a method of treating multiple sclerosis, systemic lupus erythematosis and
scleroderma with CTLA4-Ig and the use of CTLA4-Ig in combination with other
immunosuppressants. Repligen owns the exclusive rights to this patent through a
license agreement with The University of Michigan (the "University") and through
a Cooperative Research and Development Agreement with the United States Navy.
This allowed patent is independent from the patents on CTLA4-Ig which are the
subject of a lawsuit that Repligen and the University are prosecuting against
Bristol-Myers Squibb Corporation (NYSE: BMY).
"This action by the patent office acknowledges the significant inventive
contributions made by our academic licensors in demonstrating the activity of
CTLA4-Ig," stated Walter C. Herlihy, President and Chief Executive Officer of
Repligen. "With CTLA4-Ig emerging as an important new approach to autoimmune
disorders, we believe our intellectual property in this area is a significant
potential asset for our Company and we will take all appropriate actions to
enforce our rights."
CTLA4 is a T-cell regulatory protein which is one of the immune system's natural
"off switches". Repligen is developing a soluble form of CTLA4 (CTLA-Ig) which
has potential immunosuppressive activity for use in organ transplantation and
autoimmune diseases. Experiments in animals indicate that CTLA4-Ig has the
potential to block unwanted immune responses without compromising the immune
system's ability to fight off infections.
About CTLA4-Ig for Rheumatoid Arthritis
Bristol-Myers Squibb is also developing a form of CTLA4-Ig which is currently in
Phase 3 clinical trials for treatment of rheumatoid arthritis. Reports from
Phase 2 clinical studies on this product candidate presented at the American
College of Rheumatology meeting in December 2002 indicate that CTLA4-Ig has
activity in rheumatoid arthritis patients with inadequate response to therapy
with either etanercept (Enbrel(R)) or methotrexate. The studies evaluated the
addition of CTLA4-Ig to Enbrel(R) or to methotrexate in patients with active
rheumatoid arthritis despite treatment with either therapy alone. CTLA4-Ig was
well tolerated and resulted in significant, dose dependent
improvements using the American College of Rheumatology core set of outcome
measures (ACR) of joint pain, tenderness and disease activity. These results
suggest that CTLA4-Ig may have a unique activity profile in rheumatoid
arthritis. BMS is also conducting a Phase 2 clinical trial of CTLA4-Ig in
multiple sclerosis and has announced plans to initiate a Phase 2 clinical trial
in systemic lupus erythematosis later this year.
Biological Therapies for the Treatment of Rheumatoid Arthritis
In the past five years, a class of biological therapies has emerged as an
effective new approach in the treatment of rheumatoid arthritis. These drugs,
which include Amgen's Enbrel(R), Johnson and Johnson's Remicade(R) and Abbott's
Humira(R), block the activity of TNF, an inflammatory mediator which promotes
the immune attack on the lining of the joints which can lead to joint deformity,
destruction or disability. Combined sales of Enbrel(R), Remicade(R) and
Humira(R) are estimated to approach $3 billion in 2003, an increase of 50% over
2002. An estimated 25% of patients who are eligible for anti-TNF therapy remain
refractory to treatment. Additionally, although a 50% reduction in symptoms as
measured by improvement on the ACR outcome measure is considered clinically
meaningful, further benefit is ultimately desired for patients. CTLA4-Ig targets
a different step than the TNF inhibitors in the cascade of immune activation
which ultimately leads to rheumatoid arthritis and may fill a large unmet
medical need in the treatment of the disease. There are more than 2,000,000
Americans that suffer from rheumatoid arthritis.
CTLA4-Ig Inventorship Trial
Repligen is the exclusive licensee of all CTLA4-Ig patent rights owned by the
University of Michigan (the "University"). Repligen and the University believe
that the University has a rightful claim to ownership of certain patents of
Bristol-Myers Squibb ("Bristol") 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. The district Court ruled this September that there is
not sufficient evidence to name Thompson as an inventor on the patents in suit.
Repligen's failure to obtain ownership rights to the Bristol patents may
restrict Repligen's ability to commercialize CTLA4-Ig. The patents in suit are
independent from the allowed patent covering the use of CTLA4-Ig for the
treatment of rheumatoid arthritis, multiple sclerosis and systemic lupus
erythematosis.
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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