DGAP-News

Epigenomics AG: Epigenomics and BioChain enter into broad strategic collaboration in China and investment into Epigenomics

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

---------------------------------------------------------------------


- 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