Exhibit 99
For Immediate Release
Media contact
Xxx Xxxxxxxx
Xxxxxx Laboratories
000-000-0000
Financial contacts
Xxxx Xxxxxx
Xxxxxx Laboratories
000-000-0000
Xxxxxx X. Xxxxx
OraSure Technologies, Inc.
610-882-1820
ABBOTT AND ORASURE TECHNOLOGIES ENTER DISTRIBUTION AGREEMENT
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FOR ORAQUICK(R) RAPID HIV-1 TEST IN THE UNITED STATES
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- Abbott to focus on hospital and physician's office laboratory markets;
OraSure also sublicenses certain lateral-flow patents -
ABBOTT PARK, Ill., and BETHLEHEM, Pa., - June 17, 2002 - Xxxxxx
Laboratories (NYSE: ABT) and OraSure Technologies (Nasdaq NM:OSUR) today
announced agreements for the co-exclusive distribution of OraSure Technologies'
OraQuick(R) rapid test for the detection of antibodies to the Human
Immunodeficiency Virus Type 1 (HIV-1) and for a non-exclusive sublicense of
certain lateral-flow patents for which Abbott is the exclusive licensor.
OraQuick is a rapid, point-of-care test designed to detect antibodies to
HIV-1 within 20 minutes, and is the only rapid device in the world designed to
use oral fluid and whole blood samples. In June 2001, OraSure submitted an
application to the U.S. Food and Drug Administration (FDA) for pre-market
approval of the OraQuick device to test finger-stick whole blood specimens for
HIV-1. On May 11, 2002, OraSure received notification from the FDA that its
application was approvable, subject to OraSure meeting certain conditions.
OraSure intends to file an application for use of the device with oral fluid
specimens later in 2002.
"Xxxxxx Laboratories is the market leader and a terrific partner for the
distribution of infectious disease products, especially to the hospital and
physician's office laboratory markets," said Xxxx Xxxxxxxx, president and CEO,
OraSure Technologies. "We look forward to collaborating with Abbott to rapidly
expand the distribution and use of our OraQuick rapid HIV-1 test, once we
receive FDA approval to sell this product in the United States. The distribution
agreement is a validation of the quality, performance and versatility of the
OraQuick device, and we look forward to collaborating with Abbott to make
OraQuick a huge success."
"Our collaboration with OraSure will provide an important tool to assist in
the rapid detection of HIV and represents Xxxxxx'x continuing commitment to
improve diagnostic testing and medical care for people living with HIV and
AIDS," said Xxxxx Xxxxxxx, Ph.D., vice president, Diagnostic Products Research
and Development, Xxxxxx Laboratories.
Under the terms of the distribution agreement, Abbott was appointed as
co-exclusive distributor of the OraQuick HIV-1 device in the United States, and
is expected to focus primarily on the hospital and physician's office laboratory
markets. The agreement also permits OraSure Technologies to sell OraQuick
directly in the United States, and OraSure expects to sell primarily in the
public health and criminal justice markets in which it already has a direct
sales force to sell its products.
Under the sublicense, OraSure will receive non-exclusive rights to certain
lateral-flow patents issued in the United States and other countries, which are
exclusively licensed to Abbott. Lateral-flow generally refers to the use of a
test strip through which a sample flows and which provides a test result on a
portion of the strip downstream from where the sample is applied. OraSure's
sublicense to this technology initially extends to the field of human in vitro
diagnostics with an option to expand to certain other diagnostic fields, in
exchange for which OraSure will pay up-front fees and ongoing royalties.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen
collection devices using proprietary oral fluid technologies and diagnostic
products, including immunoassays and other in vitro diagnostic tests and other
medical devices. These products are sold in the United
States and certain foreign countries to government agencies, clinical
laboratories, physicians' offices, hospitals, commercial and industrial
entities, and various distributors. OraSure Technologies is the leading supplier
of oral fluid collection devices and assays to the life insurance industry and
public health markets for the detection of antibodies to HIV-1. In addition,
OraSure supplies oral fluid testing solutions for drugs of abuse testing. For
more information on OraSure, please go to xxx.xxxxxxx.xxx. OraQuick is a
registered trademark of OraSure Technologies.
About Xxxxxx Laboratories
Abbott is a leader in HIV testing, beginning with the licensure of the first HIV
test in the United States in 1985. Since then, Abbott has continually improved
the diagnostic effectiveness of its tests, targeting sensitivity to detect HIV
infections earlier and developing advanced technology to automate HIV testing
for patient diagnosis, managing therapy and screening donated blood. Abbott also
has developed important HIV therapeutics including Norvir, Xxxxxx'x first
protease inhibitor, and Kaletra, an advanced-generation protease inhibitor, for
the treatment of HIV/AIDS.
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals,
nutritionals, and medical products, including devices and diagnostics. The
company employs approximately 70,000 people and markets its products in more
than 130 countries. For more information on Abbott, please go to xxx.xxxxxx.xxx.
--Private Securities Litigation Reform Act of 1995 --
A Caution Concerning Forward-Looking Statements
For Abbott: Some statements in this news release may be forward-looking
statements for purposes of the Private Securities Litigation Reform Act of 1995.
Abbott cautions that these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially from those
indicated in the forward-looking statements. Economic, competitive,
governmental, technological and other factors that may affect Xxxxxx'x
operations are discussed in Exhibit 99.1 of our 2001 Form 10-K and in our
periodic reports on Form 10-Q and Form 8-K, and are incorporated by reference.
Abbott undertakes no obligation to release publicly any revisions to
forward-looking statements as the result of subsequent events or developments.
For OraSure: This press release contains certain forward-looking statements,
including with respect to sales, markets, products, and regulatory submissions.
Actual results could be significantly different. Factors that could affect
results include the ability to market products; impact of competitors, competing
products and technology changes; ability to develop, commercialize and market
new products; market acceptance of oral fluid testing products and other
products; ability to fund research and development and other projects and
operations; ability to obtain and timing of obtaining necessary regulatory
approvals; ability to develop product distribution channels; uncertainty
relating to patent protection and potential patent infringement claims; ability
to enter into international manufacturing agreements; obstacles to international
marketing and manufacturing of products; ability to sell products
internationally; loss or impairment of sources of capital; exposure to product
liability and other types of litigation; changes in international, federal or
state laws and regulations; changes in relationships with strategic partners and
reliance on strategic partners for the performance of critical activities under
collaborative arrangements; changes in accounting practices or
interpretation of accounting requirements; customer inventory practices and
consolidations; equipment failures and ability to obtain needed raw materials
and components; the impact of terrorism and civil unrest; and general business,
political and economic conditions. These and other factors are discussed more
fully in the Securities and Exchange Commission filings of OraSure Technologies,
including its registration statements, its Annual Report on Form 10-K for the
year ended December 31, 2001 and its most recent Quarterly Report on Form 10-Q.
Although forward-looking statements help to provide complete information about
future prospects, readers should keep in mind that forward-looking statements
may not be reliable. The forward-looking statements are made as of the date of
this press release and OraSure Technologies undertakes no duty to update these
statements.
