WALTHAM, Mass., April 8, 2008 /PRNewswire-FirstCall/ -- Repligen
Corporation (Nasdaq: RGEN) announced today that it has reached a settlement
with Bristol-Myers Squibb Company (NYSE: BMY) in its lawsuit alleging
infringement of U.S. Patent No. 6,685,941 ("the '941 patent"), based on
Bristol-Myers Squibb's sale of Orencia(R) for the treatment of rheumatoid
arthritis. The settlement provides for Bristol-Myers Squibb to make an
initial payment of $5,000,000 and to pay royalties on the U.S. net sales of
Orencia for any clinical indication at a rate of 1.8% for the first
$500,000,000 of annual sales, 2.0% for the next $500,000,000 of annual
sales and 4% of U.S. annual sales in excess of $1 billion for each year
from January 1, 2008 until December 31, 2013. The settlement also provides
for the grant by Repligen and co-plaintiff the University of Michigan to
Bristol-Myers Squibb of an exclusive worldwide license under certain patent
rights of Repligen and the University of Michigan. The settlement serves as
the basis for Repligen and co-plaintiff the University of Michigan to
dismiss the lawsuit against Bristol-Myers Squibb.
"We are very pleased by the settlement of this case which will provide
us a substantial new source of revenue," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen Corporation. "Based on
analysts' estimates of U.S. sales of Orencia(R), we expect total cash
receipts from our Protein A business, Orencia(R) royalties, research and
development and other income of greater than $30 million for fiscal year
2009, beginning April 1, 2008."
In January 2006, Repligen and the University of Michigan filed a
complaint in the United States District Court for the Eastern District of
Texas against Bristol-Myers Squibb alleging infringement of the '941 patent
based on its sale of Orencia(R). The claims of the '941 patent relate to
the use of CTLA4-Ig (Orencia(R)) for the treatment of specific auto-immune
diseases, including rheumatoid arthritis. The '941 patent is owned by the
University of Michigan and the United States Department of the Navy and is
exclusively licensed to Repligen.
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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