TUSTIN, Calif., May 13 /PRNewswire-FirstCall/ -- AMDL, Inc. , a US-based pharmaceutical company with major operations in China, announced today it has entered into two distinct five-year marketing and distribution agreements with GenWay Biotech, Inc., a global protein and antibody solutions provider, whereby GenWay Biotech will market and distribute AMDL’s DR-70 (FDP) cancer test in the US and Canada.
The partnership significantly advances AMDL’s global commercialization strategy for DR-70 specifically in the US and Canada. According to the agreed upon terms, GenWay Biotech has the rights to market and distribute AMDL’s DR-70 (FDP) cancer test for uses other than colorectal cancer to CLIA-certified laboratories in the US; and as a lung cancer screen to laboratories in Canada. This includes implementing a marketing strategy and program execution to drive product awareness and sales. GenWay Biotech will bear all responsibility for these activities. The potential value of these agreements is at least $15.8 million over a 5-year period.
“The US and Canada are major world markets for in vitro diagnostic products,” commented Mr. Douglas MacLellan, Chairman and CEO of AMDL, Inc. “We believe that GenWay Biotech is well positioned to drive market adoption with CLIA laboratories in these significant markets. This is a substantial moment in the history of AMDL’s Tustin-based operations -- not only does this agreement validate DR-70 as a viable cancer diagnostic product, it puts AMDL’s diagnostic division on a solid path to profitability.”
According to Mr. Robert Gans, CEO, GenWay Biotech, Inc., “We are dedicated to providing CLIA labs with highly innovative and in-demand products that improve the level and quality of patient healthcare around the world. We are very pleased to support the commercialization of AMDL’s DR-70 cancer test in the US and Canada. AMDL has developed a highly-effective test to provide potentially life-saving information regarding cancers and we are excited to bring it to the US and Canada.”
DR-70 (FDP) is an in vitro diagnostic test that enables physicians and their patients to effectively monitor and/or detect certain types of cancers by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). FDP levels rise dramatically with the progression of cancer. DR-70 can be used as a simple, non-invasive blood test to monitor and/or diagnose the progression or status of certain cancers. The Company received US FDA approval for DR-70 in the second quarter of FY2008 and began executing a commercialization strategy for the product late in the fourth quarter of the same year.
DR-70 has been approved by the US FDA for the monitoring of colorectal cancer and by Health Canada as a lung cancer screen and cancer monitoring tool. Following the introduction of the DR-70 (FDP) cancer test in the US and Canada, AMDL intends to expand product commercialization to select international markets based on other regulatory approvals and plans to file for marketing approvals in other areas of the globe.
For additional information on AMDL and its portfolio of products visit the Company’s corporate website at www.amdl.com. For Investor Relations information contact Kristine Szarkowitz at kszarkowitz@amdl.com or 1.206.310.5323.
About AMDL:
Headquartered in Tustin, CA with operations in China, AMDL, Inc., along with its subsidiary Jade Pharmaceutical Inc. (JPI), is a pharmaceutical company devoted to the research, development, manufacturing, and marketing of diagnostic, pharmaceutical, nutritional supplement, and cosmetic products. The Company employs over 510 people in the US and China.
About GenWay
Genway Biotech, Inc. is a diagnostic company based in San Diego, CA that manufactures and supplies key components of diagnostic kits, such as antibodies and antigens, to diagnostic companies. The Company’s proprietary technology platform specializes in producing avian IgY antibodies from genes and proteins of human, animal, plant, bacterial and other sources. GenWay also offers single chain recombinant scFv and shark vNAR antibodies. More than 40,000 products are available from the Company’s catalog. GenWay is also actively developing novel cancer diagnostic tests for point-of-care and over-the-counter diagnostics. For more information about GenWay Biotech, please visit http://www.genwaybio.com
Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to AMDL, Inc., except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.
CONTACT: Kristine Szarkowitz of AMDL, Inc., +1-206-310-5323,
kszarkowitz@amdl.com
Web site: http://www.amdl.com/
http://www.genwaybio.com/
