DGAP-News: WILEX AG: WILEX Inc. and GeneDiagnostics Inc. enter into partnership for the IVD approval and distribution of the serum HER-2/neu test in China
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Alliance
WILEX AG: WILEX Inc. and GeneDiagnostics Inc. enter into partnership
for the IVD approval and distribution of the serum HER-2/neu test in
China
23.01.2013 / 08:02
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PRESS RELEASE
WILEX Inc. and GeneDiagnostics Inc. enter into partnership for the IVD
approval and distribution of the serum HER-2/neu test in China
Munich, Germany / Hangzhou, China, 22 January 2013. WILEX AG (ISIN
DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that its US
subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive
distribution agreement with GeneDiagnostics Inc. for the commercialization
of the serum HER-2/neu ELISA test in China. This biomarker test is FDA
cleared in the USA, carries the CE mark for the European market, and is
currently for Research Use Only in the Chinese market. GeneDiagnostics
plans to conduct clinical studies in leading hospitals in China for the IVD
clearance through the State Food and Drug Administration in China (SFDA) as
part of the terms. GeneDiagnostics is a clinical research and service
provider based in Hangzhou, China, and has well-established business
relationships with major hospitals. Financial terms of the agreement were
not disclosed.
Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, comments: 'The
Chinese market is expected to be one of the fastest growing pharma markets
in the world. Therefore, we are pleased to have in GeneDiagnostics a
competent partner to pursue an IVD approval for our serum HER-2/neu test as
well as to distribute the test in this key market.'
'According to the latest statistics from the Chinese Ministry of Health
126,000 new cases of breast cancer were reported each year. This
corresponds to roughly one-tenth of the world's total and is expected to
increase by at least 4 percent annually. We look forward to introducing
this HER-2/neu ELISA test into the Chinese market as we believe that it can
help physicians administer targeted treatments to carefully diagnosed
patients with metastatic breast cancer', said Dr Mark Han, President and
Chief Scientist of GeneDiagnostics Inc.
About HER-2/neu ELISA
The serum HER-2/neu test measures the serum HER-2/neu level for the
management and monitoring of patients with metastatic breast cancer (MBC).
HER-2 (Human Epidermal Growth Factor Receptor 2) is a protein found on some
types of cancer cells, especially breast cancer cells. MBC patients who
overexpress the HER-2/neu protein tend to have a worse prognosis and a more
aggressive disease. The test measures changes in the HER-2 status with
increasing serum levels of HER-2/neu being reflective of cancer progression
while decreasing serum levels being reflective of therapy response. As the
HER-2 tumour status may change between primary and metastatic breast cancer
tumours, the serum HER-2/neu ELISA test can help monitor these changes in
HER-2/neu levels and aid doctors in managing new treatment options. This
test offers laboratories an efficient, reliable and cost-transparent
possibility for the measurement of HER-2/neu in serum with no need of
further equipment.
About GeneDiagnostics Inc.
GeneDiagnostics Inc., China, is engaged in the collaboration of R&D,
distribution and provision of diagnostic products and services used for
cancer screening, monitoring and diagnosis together with partners in China
as well as worldwide. The company has been working with leading
universities and hospitals extensively in China in introducing and
promoting new and innovative diagnostic tools and services to benefit the
patients.
About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany and
manufactures, markets and sells serum based oncoprotein diagnostics and
various biomarker tests under the brand name Oncogene Science. The product
portfolio includes Enzyme-linked ImmunoSorbent Assays (ELISA) and
immunohistochemical (IHC) assays. With the aim of supporting treatment
regimens for cancer patients worldwide WILEX Inc. offers biomarker tests
for measuring oncogenes, growth factor receptors (HER-2/neu, EGFr),
proteases and protease inhibitors (uPA, PAI-1, TIMP-1), as well as markers
of hypoxia (CA IX). In addition to the new CA IX IHC which is a class 1 IVD
test, WILEX Inc. provides the only FDA-cleared IVD ELISA that measures the
serum HER-2/neu level for the management and monitoring of patient care for
women with metastatic breast cancer. WILEX Inc. is based in Cambridge, MA,
USA and also provides GMP and ISO certified manufacturing services. More
information is available on www.oncogene.com.
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company develops diagnostic and therapeutic product
candidates for the specific detection and targeted treatment of various
types of cancer based on antibodies and small molecules. Beside the
manufacturing and marketing of the biomarker tests from WILEX Inc. the
subsidiary Heidelberg Pharma GmbH offers preclinical contract research
services and an antibody drug conjugate (ADC) technology platform. The
business model comprises research and product development as well as the
commercialisation of its activities. Our customers and partners include
leading international pharmaceutical companies. WILEX AG is listed at the
Frankfurt Stock Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More
information is available on www.wilex.com.
Contact
WILEX AG GeneDiagnostics Inc.This communication contains certain forward-looking statements relating to
Corporate Communications Mr.Chaoyang Wang
Katja Arnold (CIRO) Vice President Business Development
Grillparzerstr. 10 #2201 Snowpeak Tower
81675 Munich, Germany No.1075 Danfeng Road
Tel.: +49 (0)89-41 31 38-126 Hangzhou, 310051
Fax: +49 (0)89-41 31 38-99 Zhejiang China
Email: investors(at)wilex.com Email: wcy(at)genediagnostic.com
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
End of Corporate News
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23.01.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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199612 23.01.2013
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Datum: 23.01.2013 - 08:02 Uhr
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