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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,