DGAP-News: Epigenomics AG: Epigenomics and BioChain enter into broad strategic collaboration in China and investment into Epigenomics
(firmenpresse) - DGAP-News: Epigenomics AG / Key word(s): Agreement/Capital Increase
Epigenomics AG: Epigenomics and BioChain enter into broad strategic
collaboration in China and investment into Epigenomics
28.10.2013 / 08:00
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- BioChain to acquire exclusive development and commercial Septin9
license for China
- BioChain to invest US$ 1.3 m in Epigenomics
- Initiation of large clinical study with the goal of gaining China Food
and Drug Administration (CFDA) approval
- 5,000 Epi proColon(R) tests ordered for Q4 delivery
- Establishment of a broad research collaboration
Berlin (Germany) and Newark (California, U.S.A); Beijing (China), October
28, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the
German-American cancer molecular diagnostics company, and BioChain, a
leading clinical diagnostics company in cancer and genetic tests in China
and the US, today announced that the companies have signed an agreement
regarding a broad strategic collaboration of both companies. In addition,
BioChain will acquire 217,935 newly issued shares of the company which
corresponds to an investment of US$ 1.3m (EUR 0.94m) into Epigenomics.
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 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 ChinaCRC is a rapidly growing medical problem demanding for
better, simple to use and affordable screening methods.
Grace Tian, CEO of BioChain, commented: 'Based on our assessment of
Epigenomics' test and its significant market potential, we decided to
broaden our existing collaboration. We are pleased to introduce this
advanced cancer screening test to China and are convinced that the success
of this method in the planned clinical trial combined with the simplicity
of the Epi proColon(R) test will pave the way to high participation levels
in CRC screening in the Chinese population.'
Dr. Thomas Taapken, CEO/CFO of Epigenomics, stated: 'We are excited about
BioChain's commitment and vigorous approach to accelerate the development
of the Chinese CRC screening market with our biomarker. This agreement
reached today is the key initial step in translating our blood-based
screening assay into a major tool for colorectal cancer management in this
important region. We look forward to collaborating closely with our partner
BioChain.'
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.
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse1
10178 Berlin
Tel +49 (0) 30 24345 386
ir(at)epigenomics.com
www.epigenomics.com
For US press inquiries:
Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr(at)epigenomics.com
About Epigenomics
Epigenomics (www.epigenomics.com) is a molecular diagnostics company
developing and commercializing a pipeline of proprietary products for
cancer. The Company's products enable doctors to diagnose cancer earlier
and more accurately, leading to improved outcomes for patients.
Epigenomics' lead product, Epi proColon(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is under regulatory review by the FDA for the U.S.A. The Company's
technology and products have been validated through multiple partnerships
with leading global diagnostic companies and testing laboratories.
Epigenomics is an international company with operations in Europe and the
U.S.A.
About BioChain
BioChain (www.biochain.com, www.biochainbj.com) is a manufacturer of Life
Sciences tools and the pioneer of molecular genetics diagnostics in the US
and China. It is also the owner and operator of an independent reference
laboratory, equivalent of a CLIA lab, in China - Beijing BioChain Medical
Laboratory (BBML). BBML is unique in that it focuses on the application of
molecular diagnostics technologies and products. BBML is located in the
economic development zone of Beijing, China. Through BBML, BioChain is
committed to the application of the cutting edge 'omics' technologies in
the areas of reproductive health and cancer diagnosis.
BBML offers comprehensive services to its customers in China with a list of
cellular and molecular test menus based on diverse technologies appropriate
to each stage and type of disease. Technology platforms employed by
BioChain include karyotyping analysis of cytogenetics, fluorescent in-situ
hybridization (FISH), array comparative genomic hybridization (aCGH),
quantitative PCR (qPCR), Sanger sequencing, next generation sequencing
(NGS), multiplex ligation-dependent probe amplification (MLPA), and genetic
linkage analysis. BioChain has a strong bioinformatics team and established
the first Chromosomal Health Database for the Chinese population
(www.szjkzd.org:8080/app/auth).
Epigenomics legal disclaimer
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.
End of Corporate News
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28.10.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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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(at)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 News DGAP News-Service
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236372 28.10.2013
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