Calypte Launches International Manufacturing Initiative of its Rapid HIV Type 1 and HIV Type 2 Tests
April 01 2004 - 9:17AM
PR Newswire (US)
Calypte Launches International Manufacturing Initiative of its
Rapid HIV Type 1 and HIV Type 2 Tests Announces License and Supply
Agreement with Adaltis, Inc. ALAMEDA, Calif., April 1
/PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (BULLETIN
BOARD: CYPT) a company engaged in developing rapid tests for HIV
diagnosis and the developer and marketer of the only two
FDA-approved HIV-1 antibody tests that can be used on urine
samples, as well as an FDA-approved serum HIV-1 antibody Western
Blot supplemental test, today announced that it has entered into an
agreement with Adaltis, Inc. to license and supply certain peptides
to Calypte that are owned by Adaltis for the use in the Company's
immunodiagnostic assays. The first application for the peptides
will be in the Company's HIV rapid diagnostic tests currently under
development. The agreement provides Calypte with the supply of key,
patented HIV-Type 1 and HIV-Type 2 ("HIV-1/2") peptides by Adaltis.
Calypte's non-exclusive license to Adaltis' peptide sequences
provides the Company total freedom to operate throughout the world,
with the exception of Canada, where Calypte would work with Adaltis
in its home territory. Calypte is licensing the right to market and
sell the peptides as part of the development of its rapid HIV
diagnostic test products. Dr. J. Richard George, President and CEO
of Calypte stated, "We have used the Adaltis HIV-1/2 peptides in
the field trials of our rapid tests in Thailand. Their consistency
provides the foundation necessary to achieve the high levels of
performance we require for both specificity (false negatives) and
sensitivity (false positives). Our field trials have included our
blood rapid HIV-1/2 test for which we filed an Investigational
Device Exemption Application (IDE) in the US last November, as well
as our urine rapid HIV-1/2 test. We have also tested the product in
house with other fluids and are pleased with the initial results
from both a specificity and sensitivity perspective and are
planning to include this additional product in our upcoming field
trials later this month." Dr. George added, "In the community of
like sciences, we were encouraged to see that OraSure received FDA
approval for their laboratory based rapid oral fluid test for
HIV-1. Once our non-laboratory based rapid tests are out of
development and into production, we initially plan to distribute
them outside the United States. We believe that Calypte's products
will soon have world appeal, and after we have introduced our tests
internationally, we expect to file for FDA approval for marketing
in the US as well. However, our current focus is Sub-Saharan Africa
and the "next wave" emerging HIV epidemic countries where the
problem is more widespread -- including, China and Russia." Tony
Cataldo, Executive Chairman of Calypte stated, "As Calypte pursues
the development of its rapid HIV-1/2 tests, we believe we are now
far enough along in our development to begin finalizing the
necessary agreements and to start transferring the technology to
commercial scale manufacturing. The largest markets in the world
are the emerging markets and we believe we are now well positioned
to serve those markets. " Calypte currently has a non-exclusive
worldwide distribution agreement with Adaltis Inc. of Montreal,
Canada for the distribution of Calypte's serum HIV-1 Western Blot
test. First International Manufacturing Initiative in Thailand
Calypte is preparing for its first foreign manufacturing technology
transfer and today also announced that it has signed a Memorandum
of Understanding with Thailand-based Pacific Biotech Co., Ltd. to
act as Calypte's initial international manufacturer for both its
urine and blood rapid tests. Manufacturing will be located at the
Pacific Biotech facility in Phetchaboon, Thailand and a formal
agreement is expected to be finalized around the middle of April.
Commenting on this arrangement, Dr. George stated, "I have been
familiar with the capabilities of PacificBiotech for several years,
and have had past personal experience with them as an ISO 9001
certified contract manufacturer for rapid assays. Our recent audit
of their facilities and quality systems tells me that they are an
experienced and quality-minded organization that is eminently
qualified to manage the manufacturing task ahead of them." Ninlawan
Pichayayothin, President of Pacific Biotech, stated, "The
technologies and quality systems involved in this project are very
familiar to us. We are confident that we can manufacture the
Calypte tests at our facility in both the quality and quantity
demanded." Separately, Calypte confirmed that it continues its
focus on China, which the Company believes will be its largest
market. Beijing Calypte Biomedical Technology Ltd., the Company's
joint venture with Marr Technologies Limited, Calypte's business
partner and affiliate of Marr Technologies BV, which owns 28% of
Calypte's common stock, has begun negotiations that are expected to
lead to a manufacturing joint venture in China that will be
controlled by Beijing Calypte. The Company is optimistic that this
manufacturing relationship could facilitate a quick regulatory
approval process in China. About Adaltis: Adaltis Inc. is a
privately held company headquartered in Montreal, Canada, and in
addition to its Canadian operations, operates its own affiliates in
the USA, Italy and Germany, as well as an extensive network of over
60 sub-distributors around the world. About Pacific Biotech:
Pacific Biotech manufactures high quality diagnostic products to
serve the healthcare market world wide on both an OEM basis and
under its own brand. It has built a strong reputation for premium
quality product and superb customer services for over a decade.
Pacific Biotech products and services meet the Thai FDA compliance
standards and ISO9001. With the strong support from the Board of
Investment and National Science and Technology Development Agency,
Pacific Biotech is a model of cooperation between the government
and private sectors in promoting the development of a Thai
biotechnology industry. Pacific Biotech's products are based on
rapid immunochromatographic technologies, and include tests for
reproductive hormones, drugs of abuse, and markers ofinfectious
disease. About Calypte Biomedical: Calypte Biomedical Corporation,
headquartered in Alameda, California, is a public healthcare
company dedicated to the development and commercialization of in
vitro diagnostic tests, primarily for the detection of antibodies
to Human Immunodeficiency Virus (HIV), and other sexually
transmitted and infectious diseases. Calypte's currently marketed
laboratory-based tests include an enzyme immunoassay (EIA) HIV-1
antibody screening test and an HIV-1 antibody western blot
supplemental test, the only two FDA-approved HIV-1 antibody tests
for use on urine samples, as well as an FDA-approved serum HIV-1
antibody western blot supplemental test. Calypte is actively
engaged in developing new test products for the rapid detection of
HIV and other infectious diseases. Calypte believes that there is a
significant need for rapid detection of such diseases globally to
control their proliferation, particularly in lesser-developed
countries, which lack the medical infrastructure to support
laboratory-based testing. Calypte believes that testing for HIV and
other infectious diseases may make important contributions to
public health. Statements in this press release that are not
historical facts are forward-looking statements within the meaning
of the Securities Act of 1933, as amended. Those statements include
statements regarding the intent, belief or current expectations of
the Company and its management. Such statements reflect
management's current views, are based on certain assumptions and
involve risks and uncertainties. Actual results, events, or
performance may differ materially from the above forward-looking
statements due to a number of important factors, and will be
dependent upon a variety of factors, including, but not limited to,
the Company's ability to obtain additional financing and access
funds from its existing financing arrangements that will allow it
to continue its current and future operations and whether demand
for its test products in domestic and international markets will
continue to expand. The Company undertakes no obligation to
publicly update these forward-looking statements to reflect events
or circumstances that occur after the date hereof or to reflect any
change in the Company's expectations with regard to these
forward-looking statements or the occurrence of unanticipated
events. Factors that may impact the Company's success are more
fully disclosed in the Company's most recent public filings with
the U.S. Securities and Exchange Commission ("SEC"), including its
annual report on Form 10-KSB for the year ended December 31, 2003
and its subsequent filings with the SEC. DATASOURCE: Calypte
Biomedical Corporation CONTACT: Investor Relations - Tim Clemensen
for Calypte Biomedical Corporation, +1-212-843-9337,
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