Epigenomics AG / Key word(s): Miscellaneous
02.06.2014 21:30
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) and Germantown, MD (U.S.A.), June 2, 2014 - Epigenomics AG
(ISIN: DE000A1K0516, OTCQX: EPGNY) today announced that it has received a
response letter from the U.S. Food and Drug Administration (FDA) in
relation to its premarket approval (PMA) application for the Company's
blood-based colorectal cancer (CRC) screening test Epi proColon(R).
In its letter, the FDA determined that while the studies performed so far
have established the clinical performance characteristics of the test, the
PMA application does not yet contain sufficient evidence to warrant an
approval for Epi proColon(R). However, the FDA provided helpful guidance on
how to amend the PMA to make it approvable. The main item stressed in their
response letter revolves around the need for additional data demonstrating
that the blood-based Epi proColon(R) test will increase compliance to CRC
screening in the intended use population, i.e. in those patients who today
do not undergo CRC screening by guideline recommended methods such as
colonoscopy or FIT. Since Epigenomics' originally conducted clinical
studies were performed in patients who had agreed to a routine screening
colonoscopy, the FDA is requesting Epigenomics to demonstrate whether
patients in the targeted population can be turned compliant to CRC
screening by Epi proColon(R).
Epigenomics has scheduled a meeting with the FDA at the end of June in
order to discuss next steps and how to best address the outstanding
questions. It is expected that an additional study to demonstrate increased
compliance and adherence of patients to blood-based CRC testing will be
needed to address FDA's outstanding requests. Details around this study
will be determined in dialog with the FDA.
Formally, a "Not Approvable Letter" is issued when the FDA determines that
a PMA submission lacks significant information for approval at the time of
review. FDA will identify what is necessary to make the PMA approvable.
Epigenomics has 180 days to respond and amend the PMA, or request an
extension of time with an estimate when the requested information will be
submitted.
Epi proColon(R) is approved for marketing in Europe since 2012. The Septin9
marker has been incorporated into laboratory developed tests (LDTs) in the
United States. In addition, Epigenomics' strategic partner BioChain has
officially submitted an application to the China Food and Drug
Administration (CFDA) in April for the approval of Epi proColon(R) in the
Chinese market. Both companies expect commercialization of the test in
China to start in 2015. The FDA decision will have no impact on the
commercialization of Septin9 assays by LDT partners and on the existing
commercial arrangements for Epi proColon(R) in other regions.
- 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.
02.06.2014 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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02. June 2014 - 0:00 (CEST)