Epigenomics AG / Key word(s): Agreement
27.10.2013 19:50
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Berlin, Germany, October 27, 2013 - Epigenomics AG (ISIN: DE000A1K0516)
announces that it has signed an agreement with BioChain regarding a broad
strategic collaboration of both companies. BioChain is a leading clinical
diagnostics company in cancer and genetic tests in China and the US.
As part of the agreed collaboration, which significantly expands the
license agreement for a laboratory developed test announced earlier this
year, BioChain will acquire an exclusive license to develop and
commercialize Septin9 in vitro diagnostic (IVD) tests for colorectal cancer
(CRC) screening in the Chinese market. Under the terms of the agreement,
Epigenomics will receive undisclosed upfront and minimum annual payments as
well as mid single-digit royalty payments once the product is approved by
the Chinese Food and Drug Administration (CFDA). Until then, Epigenomics
will continue selling laboratory developed test (LDT) components to
BioChain.
At its own expense, BioChain will initiate a major clinical trial to
validate the Septin9 CRC screening assay with the goal to gain market
approval for the blood-based test by the CFDA. In order to execute the
clinical trial, BioChain has placed an order for 5,000 Epi proColon(R)
tests with Epigenomics. The trial will start in Q4 2013 and is expected to
be completed in the second half of 2014.
This is the first clinical study to demonstrate the clinical utility of the
Septin9 assay in China, where, in accordance with internationally accepted
guidelines, nearly 290 million people are currently eligible for CRC
screening. In China CRC is a rapidly growing medical problem demanding for
better, simple to use and affordable screening methods.
The parties also agreed to work together on the validation of other
methylation biomarkers in the cancer field. Epigenomics owns intellectual
property around a variety of cancer diagnostic markers for lung, prostate
and bladder cancer as well as for other solid tumors and markets a
CE-marked product for lung cancer diagnosis based on its proprietary SHOX2
biomarker. BioChain's advanced sample preparation technology is a valuable
asset for the clinical validation of Epigenomics' other DNA-methylation
cancer markers. Should the companies develop any future products, BioChain
shall have the option to acquire commercialization rights for the Chinese
market, while Epigenomics will retain rights for the rest of the World.
- End of Ad hoc -
Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
Epigenomics' legal disclaimers. This communication expressly or implicitly
contains certain forward-looking statements concerning Epigenomics AG and
its business. Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Epigenomics AG to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Epigenomics AG is
providing this communication as of this date and does not undertake to
update any forward-looking statements contained herein as a result of new
information, future events or otherwise.
The information contained in this communication does not constitute nor
imply an offer to sell or transfer any product, and no product based on
this technology is currently available for sale by Epigenomics in the
United States or Canada. The analytical and clinical performance
characteristics of any Epigenomics product based on this technology which
may be sold at some future time in the U.S. have not been established.
27.10.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of Announcement DGAP News-Service
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27. October 2013 - 0:00 (CEST)