AMDL Signs Exclusive Licensing Agreement for Human Papilloma Virus Diagnostic Test Kit in Certain Asian Countries
April 03 2008 - 5:00AM
PR Newswire (US)
TUSTIN, Calif., April 3, 2008 /PRNewswire-FirstCall/ -- AMDL, Inc.
(AMEX:ADL), headquartered in Tustin, California, with operations in
Shenzhen, Jiangxi, and Jilin, China, is a vertically integrated
specialty pharmaceutical company. In combination with its
subsidiary Jade Pharmaceutical Inc. ("JPI"), AMDL engages in the
research, development, manufacture, and marketing of diagnostic
products. Today, AMDL announced that it has entered into an
exclusive sublicense (subject to certain terms and conditions)
agreement with MyGene International, Inc. ("MGI," USA) for the
MyGene HPV Chip Kit, a diagnostic product for in-vitro genotype
testing in women with the Human Papilloma Virus (HPV). The
agreement between MGI and AMDL is an exclusive sublicense to use
the patents, trademark, and technology in manufacturing, promoting,
marketing, distributing, and selling the MyGene HPV Test Kit in the
countries of China (including Hong Kong), Taiwan, Singapore,
Malaysia, Thailand, Cambodia, and Vietnam. MGI owns an exclusive
worldwide license (with rights to sublicense) for the MyGene HPV
Test Kit (excluding Korea). HPV is the most common sexually
transmitted infection. Globally there are approximately 330 million
women presently infected with HPV, with 70% of existing infections
in Asian populations. The virus infects the skin and mucous
membranes. There are more than 30 important HPV types that can
infect the genital areas of men and women, including the skin of
the penis, vulva (area outside the vagina), and anus, and the
linings of the vagina, cervix, and rectum. Most people who become
infected with certain types of HPV do not even know they have it.
Cervical cancer, in which malignant cells form in the tissue of the
cervix, is third leading cancer in women and the second leading
cause of cancer deaths in women worldwide. It is well known that
certain HPV types are the primary cause of cervical cancer. If HPV
infection is detected early, cervical cancer could be preventable.
Early diagnosis of HPV infection, which could lead to cervical
cancer, is recommended for every woman. According to recent
clinical trial assessments, it was reported in Medical News Today
that the global market for HPV testing is projected to be $250
million in 2008, with the total available market valued at $1
billion. There are more than 10 million HPV tests being performed
annually in the United States alone, with only 28% market
penetration. According to the 2007 CIA Factbook, in China there are
approximately 455 million women between the ages of 15 and 64 years
old. In China alone, at an extremely conservative estimate of 1
million possible patients, with HPV screening at a cost of
approximately $50, there is a $50 million annual market potential
for HPV testing in China. Estimates indicate that HPV testing in
China could grow from approximately 16 million tests in 2009 to
over 25 million by 2025. Mr. Gary Dreher, CEO of AMDL, noted that
"this HPV Diagnostic Test Kit is anticipated to become a major
product for the Company. This sublicense agreement demonstrates
AMDL's capability to in-license state of the art diagnostic
products that can gain swift regulatory approval and market
acceptance." Dr. Tyler McCabe, President and CEO of MGI indicated,
"In China alone, with skillful effort, substantial sales potential
could be realized within a few years. MGI is excited about the
potential of this relationship, due to AMDL's infrastructure in
China and certain Asian countries, and we look forward to working
together to enter this large market." About Jade Pharmaceutical:
JPI has access to the fastest growing pharmaceutical and consumer
market in the world: China. AMDL, through its subsidiaries, JPI
currently manufactures large volume injection fluids, tablets and
other related products, holding licenses for 133 products. It also
manufactures 107 generic, over the counter and supplemental
pharmaceutical products under certified Chinese Good Manufacturing
Practice (CGMP) standards. About AMDL: More information about AMDL
and its products can be obtained at http://www.amdl.com/.
Forward-Looking Statements This news release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to certain risks and uncertainties, and actual
circumstances, events or results may differ materially from those
projected in such forward-looking statements. The Company cautions
readers not to place undue reliance on any forward-looking
statements. The Company does not undertake, and specifically
disclaims any obligation, to update or revise such statements to
reflect new circumstances or unanticipated events as they occur.
Contact: AMDL, Inc. Mr. Paul Knopick AMDL Investor Relations Direct
Line: 949.707.5365 VoiceMail: 714.505.4460 DATASOURCE: AMDL, Inc.
CONTACT: Mr. Paul Knopick, AMDL Investor Relations,
+1-949-707-5365, VoiceMail, +1-714-505-4460, for AMDL, Inc. Web
site: http://www.amdl.com/
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