Calypte Biomedical Corp. (ticker: CALY, exchange: NASDAQ) News Release - 15-Oct-2002
-------------------------------------------------- Calypte Receives First Commercial Order in China With New Distributor; Order for 100,000 Tests to Ship in Fourth Quarter 2002
ALAMEDA, Calif., Oct 15, 2002 (BUSINESS WIRE) -- Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA approved HIV-1 antibody tests for use with urine samples, announced that it has received its first commercial order from its new Chinese distributor for the Urine HIV-1 EIA. Calypte has signed an exclusive two-year distribution agreement with Zhong Yang Pute Co. ("ZYPute"), a distributor of medical products in China. The agreement calls for minimum purchase orders of Calypte's products, which are expected to add at least $3 million in revenue over the next two years. The company will begin manufacturing the first order of over 100,000 tests imminently, with shipping expected to occur in the fourth quarter. The agreement is automatically extendable for an additional two years contingent upon the distributor's performance and new minimum purchases will be negotiated at that time.
The agreement gives exclusive rights to distribute the Urine HIV-1 EIA and Urine HIV-1 Western Blot tests to specific market segments within 20 of the 31 Chinese provinces and to the military nationwide, along with non-exclusive distribution rights for the Serum HIV-1 Western Blot tests in the same territories. Calypte's Urine EIA test has been approved for distribution by the Chinese State Drug Administration (SDA) to customers that do not require lot release testing.
"Traditional blood testing is expensive, difficult to handle, poses potential risk hazards and can be culturally unacceptable in some parts of the world," stated Anthony Cataldo, executive chairman of Calypte. "Our tests provide a safe, non-invasive and cost-effective alternative with none of the risks associated with blood testing. The agreement with ZYPute is another example of Calypte's execution of acheivement milestones. We expect our products to play a major role in China's fight against HIV/AIDS. The agreement does not include our revolutionary Rapid Urine Test, which is anticipated to have a much larger market in China and the rest of the world than the current EIA."
According to a recent report by the United Nations, China could have more than 10 million HIV cases by 2010. China's health ministry has confirmed over one million cases and a 16% year-over-year increase in the number of people infected. China is now estimated to have Asia's fourth largest number of people infected with HIV/AIDS. Dr. Luc Montagnier, co-discoverer of HIV-1 and consultant to Calypte, visited with the Chinese government in August 2002 to discuss the increase in the need for continued mass screening for HIV. During the visit, he demonstrated the advantages of urine-based screening and promoted the Calypte product.
Nancy Katz, president and CEO of Calypte, stated, "We have been focused on gaining access to the Chinese market and securing distribution through a commercial distributor. Our choice in ZYPute stemmed from their steadfast belief that the minimum purchase requirements will be exceeded over the term of the agreement. Calypte stands to gain sizeable volume orders from this relationship and we look forward to a long and productive relationship with ZYPute. "
Katz added, "Already ZYPute has identified commercial applications for our Urine HIV EIA with the current level of SDA approval. We continue to pursue approval by the Biologics division of the SDA by early 2003, which will enable Calypte to sell tests to those customers that do require specific lot testing."
About Zhong Yang Bio-Medi-Tech (ZYPute):
ZYPute was previously one of 17 affiliates organized under the corporate umbrella of Beijing Pharmaceutical Co., a conglomerate with US$70 million in assets, and 3 publicly traded companies. ZYPute merged with HuaXin International Economic & Trade Co. Ltd., a company owned and operated by the Ministry of Foreign Trade and Economic Cooperation. Together, the companies have established 3 regional offices that will manage a network of 10 experienced sub-distributors, operating in 20 provinces. The union of the two companies gives ZYPute exceptional insight into the procurement processes of several markets in China that Calypte believes to be important consumers of HIV testing products, and the ability to communicate with policy-makers at levels that are normally not accessible to regional sub-distributors. Although ZYPute was initially established as a distributor of aircraft supplies, primarily to the military, the company is now focused exclusively in the medical field. Its core medical business includes a range of hospital products in the field of infant nutrition.
About Calypte Biomedical:
Calypte Biomedical Corporation headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. When compared with existing blood-based tests, our testing algorithms are non-invasive, easier to use, less expensive and have significantly less risk than blood-based testing, and they have 99.7% sensitivity in subjects previously identified as HIV-1 infected and 100% specificity in subjects at low risk when combined with the urine-based Western Blot supplemental test. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. 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, our ability to obtain additional financing and access funds from our existing financing arrangements that will allow us to continue our current and future operations and whether demand for our product and testing service 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-K for the year ended December 31, 2001 and its subsequent filings with the SEC.
CONTACT: Calypte Biomedical Corporation Richard VanMaanen, 510/749-5153 (Director Intl Business Development) email:dvanmaanen@calypte.com or Investor Relations Contact: Lippert/Heilshorn & Associates Brendan Lahiff/Kirsten Chapman, 415/433-3777 email:brendan@lhai-sf.com
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