BUSINESS WIRE; November 17, 1997.
The agreement also gives SDS access to patented raw materials, facilitating manufacture and distribution of new and existing test kits.
Under this agreement, a private label agreement, SDS will sell its rapid HIV test components to BioChem ImmunoSystems for marketing and distribution under the BioChem ImmunoSystems brand label. The three year agreement allows BioChem ImmunoSystems to market the HIV test products worldwide, excluding India and Israel where SDS already has exclusive distribution arrangements. BioChem ImmunoSystems shall assume responsibility for the local registration of the products it will be marketing. If independent clinical trials are required for government approvals, the costs will be shared between SDS and BioChem ImmunoSystems.
"The execution of this agreement is a significant move forward for SDS", said Kenneth J. McLachlan, President and Chief Executive Officer of SDS. "BioChem ImmunoSystems has established marketing and distribution systems, which will help bring our products to the international market at a much faster pace. It is especially exciting because the agreement takes our rapid tests into the European markets for the first time.
"BioChem ImmunoSystems will also be working with us on Canadian trials of the rapid HIV tests beginning in January 1998," continued McLachlan. "If we obtain approval in Canada it will open up new markets and results from the trials may help us when we seek U.S. FDA approval for the tests."
Based in Montreal, Canada, and with operations worldwide, BioChem ImmunoSystems is the diagnostics subsidiary of BioChem Pharma Inc., an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. BioChem Pharma's discoveries include 3TC(TM)/Epivir(TM)(note a) a drug used in combination with other drugs for the treatment of HIV infection and AIDS.
Saliva Diagnostic Systems, Inc. is a developer and manufacturer of rapid tests for infectious diseases and certain other conditions. The company is based in Vancouver, Washington with a sales office in London, England. SDS products include a range of rapid tests to detect HIV antibodies that use serum, whole blood or saliva for analysis. The tests, which require only a few simple steps to use, are designed to produce results within minutes without special equipment, training or storage. The company has also developed a rapid blood test to detect H.pylori (a bacteria linked to peptic ulcers), and is in the process of developing rapid serum tests for Hepatitis A and Tuberculosis.
This press release contains forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to vary include: demand for the company's products, the ability of the company to increase manufacturing capacity, the ability of the company to obtain regulatory approvals, success in the Company's technological advances and their implementation, cost and yield issues associated with production, the ability of the company to raise additional capital, as well as other risk factors listed in the Company's the Registration Statement on form S-3 dated September 26, 1997.
a: 3TC(TM)/Epivir(TM) are registered trademarks of Glaxo Wellcome plc.
CONTACT: Saliva Diagnostic Systems, Inc. Tel: 360/696-4800 Fax: 360/254-7942
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