AspenBio Pharma Enters Into Development and Supply Agreement for AppyScore(TM) Reader
Company Partners With Leading Diagnostic Instrument Manufacturer
CASTLE ROCK, CO--(Marketwire - January 28, 2010) - AspenBio Pharma, Inc. (NASDAQ: APPY), an
emerging bio-science company dedicated to the development of novel
diagnostics and drugs for humans and animals, announced that it has entered
into a strategic relationship with LRE Medical GmbH (LRE) to complete
commercial development and manufacture of the reader instrument to be used
with the AppyScore™ cassette system.
LRE, a wholly owned subsidiary of Esterline Corporation (NYSE: ESL) is a
leader in the development and manufacture of medical devices with a special
focus in instruments for point-of-care and near patient testing. LRE is
ISO 13485 certified, experienced in manufacturing for IVD and MDD devices
requiring the CE mark in the EU, and is registered with the FDA as a
contract manufacturer for medical device products.
"We are fortunate to be working with LRE who brings over 40 years of
experience in medical device manufacturing and has built a successful track
record in developing instruments currently in use in emergency and critical
care settings," said Daryl J. Faulkner, Chief Executive Officer of AspenBio
Pharma. "LRE provides AspenBio with a proven instrument platform to
commercialize our novel assay and strengthens an important part of our
supply chain."
The ELISA format of the AppyScore Test is currently in clinical trials for
clearance by the FDA and is designed to aid in the evaluation of patients
suspected of having acute appendicitis. In addition to the ELISA format,
the company has been developing a cassette and instrument format of the
test, which will also require separate regulatory clearance prior to
commercialization. Under the terms of the agreement, LRE will be the
exclusive manufacturer of the instrument and will be responsible for
providing the required manufacturing capacity and quality standards
necessary to meet global market demands.
About AspenBio Pharma, Inc.
AspenBio Pharma is an emerging bio-science company dedicated to the
discovery, development and commercialization of novel products that address
unmet diagnostic and therapeutic needs in both human and animal health. The
Company's AppyScore blood-based test addresses the difficult challenge of
diagnosing human appendicitis in the hospital emergency department. The
Company is also advancing unique therapeutic proteins designed to improve
reproduction in non-companion animals of economic importance. For more
information, go to www.aspenbiopharma.com.
Forward-Looking Statements
This news release includes "forward-looking statements" of AspenBio Pharma,
Inc. ("APPY") as defined by the Securities and Exchange Commission ("SEC").
All statements, other than statements of historical fact, included in the
press release that address activities, events or developments that APPY
believes or anticipates will or may occur in the future are forward-looking
statements. These statements are based on certain assumptions made based
on experience, expected future developments and other factors APPY believes
are appropriate in the circumstances. Such statements are subject to a
number of assumptions, risks and uncertainties, many of which are beyond
the control of APPY. Investors are cautioned that any such statements are
not guarantees of future performance. Actual results or developments may
differ materially from those projected in the forward-looking statements as
a result of many factors, including statements regarding the ability to
successfully complete the clinical trial data assessments required for FDA
submission, obtain FDA clearance for, cost effectively manufacture and
generate revenues from the appendicitis test as well as the animal products
and other new products, execute agreements required to successfully advance
the Company's objectives, retain the scientific management team to advance
the products, overcome adverse changes in market conditions and the
regulatory environment, fluctuations in sales volumes, obtain and enforce
intellectual property rights, and realization of intangible assets.
Furthermore, APPY does not intend (and is not obligated) to update publicly
any forward-looking statements. The contents of this news release should
be considered in conjunction with the warnings and cautionary statements
contained in APPY's recent filings with the SEC.