Calypte Launches International Manufacturing Initiative of its Rapid HIV Type 1 and HIV Type 2 Tests
Announces License and Supply Agreement with Adaltis, Inc. Memorandum of Understanding Signed for Initial Manufacturing of HIV-1/2 Rapid Tests in Thailand
THURSDAY , APRIL 01, 2004 09:17 AM
ALAMEDA, Calif., Apr 1, 2004 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC 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 Pacific Biotech 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.
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