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Epigenomics AG: FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval

Epigenomics AG / Key word(s): Miscellaneous

02.06.2014 / 21:30


  • Meeting to discuss next steps with FDA scheduled in June
  • FDA decision has no impact on commercialization of Septin9-based tests by LDT partners or existing commercial arrangements for Epi proColon(R) in other regions
  • Company remains committed to offer highly efficient and convenient alternative for CRC screening

Berlin (Germany) and Germantown, MD (U.S.A.), June 2, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, 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.

“We were surprised with FDA’s assessment of our PMA submission. While this is not what we expected, we remain fully committed to offering people who are unwilling or unable to undergo recommended CRC screening a highly efficient and convenient alternative for CRC screening,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We will continue the dialog with the FDA to learn more about the background of the agency’s assessment and will work diligently to amend our PMA application accordingly in order to determine an appropriate path forward towards US market approval.”

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.

Conference call

Epigenomics’ management will host a conference call at 4:30 pm CET/10:30 am EST on Tuesday, June 3rd, 2014.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): + 49 69 247501895

Dial-in number (within the UK): + 44 203 3679216

Dial-in number (within the U.S.): + 1 408 9169838

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

A replay of the conference call will be provided on Epigenomics’ website subsequently: https://www.epigenomics.com/en/news-investors.html

– Ends –

Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For U.S. press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@epigenomics.com

About Epi proColon(R)

The Epi proColon(R) test is a qualitative assay for the detection of methylated Septin9 DNA (SEPT9) in human blood plasma using real-time PCR, a common method being routinely used in most diagnostic laboratories. Analysis of Septin9 DNA-methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC. Septin9 testing is dedicated to serve as an attractive alternative to existing CRC screening methods including fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), and flexible sigmoidoscopy in patient populations where sufficient compliance to CRC screening programs is not achieved.

About Colorectal Cancer (CRC)

Today, CRC is the third most common cancer diagnosed in men and women in the U.S. and the second leading cause of death from cancer among adults. According to the American Cancer Society, it is estimated that there will be around 96,830 new cases of colon cancer and roughly 40,000 new cases of rectal cancer being diagnosed in the U.S. in 2014. In the same period, approximately 50,310 patients will die from this disease. However, routine screening programs could dramatically increase chances of survival.

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. and the Chinese Food and Drug Administration for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in Europe. 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.

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.

End of Corporate News


02.06.2014 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.

DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de



271804  02.06.2014
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Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval

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.

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

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

---------------------------------------------------------------------------
 
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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Epigenomics AG: Veröffentlichung gemäß § 26 Abs. 1 WpHG mit dem Ziel der europaweiten Verbreitung

Epigenomics AG 

20.05.2014 12:25

Veröffentlichung einer Stimmrechtsmitteilung, übermittelt durch die DGAP - ein Unternehmen der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.

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


Veröffentlichung einer Mitteilung nach § 26 Abs. 1 Satz 1 WpHG mit dem Ziel
der europaweiten Verbreitung

Veröffentlichungspflichtiger Emittent: 
Epigenomics AG 
- ISIN DE000A1K0516 - 
Kleine Präsidentenstr. 1 
10178 Berlin 
Deutschland 

Angaben zu veränderten Stimmrechtsanteilen: 

 1. Am 16. Mai 2014 hat die Abingworth Bioventures V GP Ltd., London,
    Vereinigtes Königreich, der Epigenomics AG gemäß § 21 Abs. 1 WpHG
    mitgeteilt, dass der Stimmrechtsanteil der Abingworth Bioventures V GP
    Ltd., London, Vereinigtes Königreich, an der Epigenomics AG am 13. Mai
    2014 den Schwellenwert von 10 % unterschritten hat und zu diesem Tag
    9,93 % beträgt (entspricht 1.342.190 Stimmrechte). Die 9,93 %
    Stimmrechtsanteile (entspricht 1.342.190 Stimmrechte) sind der
    Abingworth Bioventures V GP Ltd., London, Vereinigtes Königreich, gemäß
    § 22 Abs. 1 Satz 1 Nr. 1 WpHG zuzurechnen.

Der Abingworth Bioventures V GP Ltd. zugerechnete Stimmrechte werden dabei
über folgende von der Abingworth Bioventures V GP Ltd. kontrollierte
Unternehmen, deren Stimmrechtsanteil an der Epigenomics AG jeweils 3 % oder
mehr beträgt, gehalten:

  - Abingworth Bioventures V GP LP
  - Abingworth Bioventures V LP
  - Abingworth Bioventures V Co-Invest Growth Equity Fund LP

 2. Ferner hat die Abingworth Bioventures V GP Ltd. der Epigenomics AG am
    16. Mai 2014 gemäß §§ 21, 24 Abs. 1 WpHG mitgeteilt, dass der
    Stimmrechtsanteil der Abingworth Bioventures V GP LP., London,
    Vereinigtes Königreich, an der Epigenomics AG am 13. Mai 2014 den
    Schwellenwert von 10 % unterschritten hat und zu diesem Tag 9,93 %
    beträgt (entspricht 1.342.190 Stimmrechte). Die 9,93 %
    Stimmrechtsanteile (entspricht 1.342.190 Stimmrechte) sind der
    Abingworth Bioventures V GP LP gemäß § 22 Abs. 1 Satz 1 Nr. 1 WpHG
    zuzurechnen.

Der Abingworth Bioventures V GP LP zugerechnete Stimmrechte werden dabei
über folgende von der Abingworth Bioventures V GP LP kontrollierte
Unternehmen, deren Stimmrechtsanteil an der Epigenomics AG jeweils 3 % oder
mehr beträgt, gehalten:

  - Abingworth Bioventures V LP
  - Abingworth Bioventures V Co-Invest Growth Equity Fund LP

Datum dieser Veröffentlichung: 20. Mai 2014 

Epigenomics AG 
Der Vorstand 

Kontakt: 
Epigenomics AG 
Antje Zeise
Manager Investor Relations
Tel.: +49 (0)30 24345 386 
Fax: +49 (0)30 24345 555 
Email: antje.zeise@epigenomics.com



20.05.2014 Die DGAP Distributionsservices umfassen gesetzliche 
Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen. 
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de

---------------------------------------------------------------------------
 
Sprache:      Deutsch
Unternehmen:  Epigenomics AG
              Kleine Präsidentenstraße 1
              10178 Berlin
              Deutschland
Internet:     www.epigenomics.com
 
Ende der Mitteilung                             DGAP News-Service
 
---------------------------------------------------------------------------

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Epigenomics AG: Epigenomics AG Announces Q1 2014 Financial Results and Reports on Operational Highlights

Epigenomics AG / Key word(s): Quarter Results

13.05.2014 / 08:30


Berlin (Germany) and Germantown, MD (U.S.A.), May 13, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced its financial results for the first quarter ending March 31, 2014.

  • Q1 2014 revenue increased by 14% compared to Q1 2013 to EUR 407 thousand driven by increased product sales
  • Liquid assets at period-end increased to EUR 8.4 million due to proceeds from conversion of convertible notes
  • FDA Advisory Committee provides recommendations for Epi proColon(R) in the U.S.
  • Chinese partner BioChain completed major clinical validation study and submitted an application to the CFDA for the approval of Epi proColon(R) in China

“Over the last weeks, additional progress was made in the regulatory process for our blood-based screening assay for the early detection of colorectal cancer (CRC) Epi proColon(R), since the FDA Medical Devices Advisory Committee voted positively that the test’s benefits outweigh its risks for use in patients who meet the criteria. Subsequently, we met again with the agency to discuss topics raised in the Advisory Committee meeting, including the design of the proposed post-approval study”, said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “Another important step towards commercialization of our key value driver was taken by our Chinese partner BioChain with the earlier than expected completion of a major clinical validation study with Epi proColon(R) and the official start of the market approval process with the Chinese Food and Drug Administration (CFDA) in China. We are expecting the test could enter the Chinese market in 2015. Overall, we are very pleased with the excellent progress we made with our test in many regions of the world and strongly believe that the launches of Epi proColon(R) will help to increase the number of people being tested early for CRC.”

Q1 2014 Financial Results

  • Q1 2014 revenue increased by 14% to EUR 407 thousand (Q1 2013: EUR 355 thousand); thereof, product revenue in Q1 2014 increased by more than 30% year-on-year (from EUR 163 thousand to EUR 215 thousand).
  • Q1 2014 operating costs increased to EUR 2.5 million, up 14% from EUR 2.2 million in Q1 2013. This increase was primarily attributable to higher R&D cost of EUR 1.3 million (Q1 2013: EUR 1.1 million) due to higher costs for international patent protection. SG&A costs of EUR 1.0 million remained almost at last year’s level.
  • EBIT for Q1 2014 amounted to EUR -2.0 million (Q1 2013: EUR -1.7 million) and net loss to EUR 2.2 million (Q1 2013: EUR 1.7 million), including interest expenses in the amount of EUR 0.2 million (Q1 2013: EUR 0) incurred in connection with the issued convertible notes. Due to the increased number of shares outstanding at the end of Q1 2014, net loss per share increased only slightly from EUR 0.16 to EUR 0.17 compared to Q1 2013.
  • Net cash flow in Q1 2014 was EUR 0.4 million. Cash inflow from financing activities amounted to EUR 1.9 million and was mainly attributable to the issuance of 428,000 new shares in context with the conversion of convertible notes. Cash outflow from operating activities was EUR 1.5 million – a decrease of EUR 0.3 million compared to Q1 2013 (EUR 1.8 million) – mainly attributable to changes in current and non-current liabilities from operations.
  • Liquid assets at the end of the period amounted to EUR 8.4 million (December 31, 2013: EUR 8.0 million). Four of the 25 convertible bonds issued in December 2013 have been converted and EUR 2.1 million was raised this way during Q1 2014. These conversions have not only given more financial leeway but as well reduced the redemption amount in a non-conversion scenario.

Operational highlights

  • Final Phase of U.S. Market Approval Process, Expert Panel Recommends Epi proColon(R): On March 26, the meeting of the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee (“Advisory Committee”) was held in conjunction with the premarket approval (PMA) for Epigenomics’ blood-based CRC screening test Epi proColon(R) in the U.S.A. The Advisory Committee reviewed the Company’s clinical data and the performance of Epi proColon(R), discussed data and questions presented by the FDA as well as testimonies shared during the open public hearing. After deliberations, the Advisory Committee members in their majority voted positively that the benefits of Epi proColon(R) outweigh the risks for use in patients who meet the criteria. Epigenomics is diligently preparing itself, together with its U.S. commercial partner Polymedco, for the planned U.S. commercialization in order to ensure the optimum market introduction and roll-out of Epi proColon(R) in North America.
  • Major Progress with Epi proColon(R) in China (after the End of the Reporting Period), Commercialization Expected for 2015: In April, Epigenomics announced that its Chinese partner BioChain has completed a major clinical study to validate Epi proColon(R) for the early detection of CRC with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to the CFDA in April for such approval. The commercialization of Epi proColon(R) in China is expected to start in 2015.
  • Argentina Becomes First Country outside of Europe to Launch Epi proColon(R): In March, Epigenomics’ local partner in Buenos Aires, VSA Alta Complejidad S.A. (“VSA”), received approval to market the Epi proColon(R) kit for the blood-based detection of CRC in Argentina, a country where CRC mortality rates are still among the highest for males and females. The test was made available by VSA in the same month on the occasion of the international “Colon Cancer Awareness Month” campaign.
  • Clinical Study with Epi proColon(R) Completed with Excellent Results in the Czech Republic: A study conducted by MU Dr. Zdenek Beneš, CSc., Head, Medical Department of Thomayer Hospital, Prague, confirmed that blood-based Septin9 testing could be an attractive screening alternative to established methods for a population that would otherwise be non-compliant to CRC screening. In this case control study comprising 57 patients, Epi proColon(R) 2.0 CE showed a sensitivity of 92% and a specificity of 97%.
  • Intellectual Property Coverage for Epi proColon(R) Strengthened in the U.S. and in China: The Company was granted patent protection for the method used in Epi proColon(R) to analyze Septin9 DNA methylation by the United States Patent and Trademark Office (USPTO). In addition, Epigenomics received a “Notice of Allowance” from the Chinese Patent and Trademark Office for a patent covering Epigenomics’ Septin9 DNA methylation biomarker (mSEPT9) for use in the diagnosis of CRC.

Outlook

  • The most significant milestone for Epigenomics over the next weeks remains the approval decision for Epi proColon(R) by the FDA.
  • With regard to the earnings prognosis for the current business year, there are no significant changes compared to our statements in the consolidated management report for 2013. However, Epigenomics might adjust its product revenue prognosis upwards for 2014, if market approval for Epi proColon(R) in the U.S.A. would be granted in due course. According to the 2013 management report, Epigenomics expects revenue in 2014 to slightly increase from 2013 levels. Net loss for 2014 is expected to be in the range of EUR 7.5 to 8.5 million. In line with the expected net loss range, cash consumption for fiscal 2014 is projected at a slightly increased level compared to 2013 in the range of EUR 7.0 to 8.0 million.
  • The financial prognosis might be adjusted upon further conversions of issued convertible notes. However, the Company will continue to diligently explore and potentially execute all strategic options available to further strengthen its liquidity position. These options explicitly include further capital market transactions.

Further Information

Conference call for press and analysts

The full Q1 2014 Financial Report can be obtained from Epigenomics’ website at:
https://www.epigenomics.com/en/news-investors/investors/financial-reports/2014.html

– Ends –

Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For U.S. press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@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. and the Chinese Food and Drug Administration for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in Europe. 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.

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.A. have not been established.

End of Corporate News


13.05.2014 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.

DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de



267949  13.05.2014
Read more

Epigenomics AG: Epigenomics Updates on Regulatory Status for Epi proColon(R) in the U.S.A.

Epigenomics AG / Key word(s): Miscellaneous

29.04.2014 / 09:00


Berlin (Germany), Germantown, MD (U.S.A.), April 29, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today provides an update on the status of its discussions with the Food and Drug Administration (FDA) regarding Epi proColon(R), the Company’s blood-based colorectal cancer (CRC) screening test, following a recent meeting with the premarket approval (PMA) review team at the FDA. The meeting focused on detailed discussions regarding submitted data, product labeling, design of the proposed post-approval study as well as on topics raised at the recent Medical Devices Advisory Committee (“Advisory Committee”) meeting and progress was made in addressing open issues. The post-approval study proposed by Epigenomics is intended to investigate the test’s longitudinal performance in a programmatic setting to assess the long-term benefits of CRC screening using Epi proColon(R).

Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: “We look forward to continuing to diligently collaborate with FDA over the weeks to come on the topics discussed. While FDA regulations do not allow Epigenomics to anticipate a decision or decision date, we remain confident that the data submitted supports our PMA application for Epi proColon(R).”

The Company initially completed the PMA filing for Epi proColon(R) for FDA approval in early 2013. As part of the PMA review process, an Advisory Committee was convened by the FDA on March 26, 2014 to discuss and evaluate the effectiveness, safety and the benefit-risk profile of Epi proColon(R). Members of the Advisory Committee voted positively that the benefits of Epi proColon(R) outweigh the risks of the test for use in patients who meet its application criteria.

– Ends –

Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For U.S. press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@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. and the Chinese Food and Drug Administration for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in Europe. 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.

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.A. have not been established.

 

End of Corporate News


29.04.2014 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.

DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de



265237  29.04.2014
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Epigenomics AG: Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China

Epigenomics AG / Key word(s): Study/Miscellaneous

24.04.2014 / 12:10


  • 74.8% sensitivity and 97.4% specificity demonstrated in cohort of 1,074 patients; results in line with those achieved in the European CE marking study reported in 2011
  • BioChain filed for regulatory approval of Epi proColon(R) with the CFDA, expecting commercialization of the test to start in 2015

Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China), April 24, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, and BioChain Institute Inc. (BioChain), a leading clinical diagnostics company in cancer and genetic tests in China and the U.S.A., today announced that BioChain has completed its major clinical validation study to validate Epigenomics’ blood-based Septin9 screening assay Epi proColon(R) for the early detection of colorectal cancer (CRC) with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to China Food and Drug Administration (CFDA) in April for the approval of Epi proColon(R). Both companies expect commercialization of the test in China to start in 2015.

The clinical validation study was designed to evaluate the clinical performance of Epi proColon(R) for the detection of CRC and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top ranking hospitals in China were tested by using Epigenomics’ Epi proColon(R) 2.0 CE assay. Epi proColon(R) detected 74.8% of the cancer cases (sensitivity) and correctly identified 97.4% of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive.

The results were in line with those achieved in Epigenomics’ European CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity).

Grace Tian, CEO of BioChain, commented: “We are excited about the excellent performance of Epi proColon(R) in this clinical trial. These results and the filing for regulatory approval of Epi proColon(R) with the CFDA are significant milestones towards commercialization of this sophisticated cancer screening test in the Chinese market. We strongly believe that the convenience and the simplicity of the blood-based Epi proColon(R) test will pave the way to significantly improve CRC screening in China.”

Dr. Thomas Taapken, CEO/CFO of Epigenomics, added: “We are thrilled that BioChain completed this clinical study sooner than anticipated, which expresses their strong commitment and enthusiasm to bring our test into the Chinese market. CRC has a very good prognosis if detected at an early stage. Regular screening for cancer, therefore, is highly desirable. We are proud to contribute to implement CRC screening based on a convenient blood-based test to reduce incidence and mortality of the disease in China.”

This was the first clinical study to demonstrate the clinical utility of the Septin9 assay in China. In accordance with internationally accepted guidelines, nearly 290 million people are currently eligible for CRC screening in China and effective testing methods that are accepted by patients are needed. CRC is a rapidly growing medical problem. In a report published in December 2013, the independent market research firm Decision Resources estimates that the number of incident cases of CRC in urban areas of China will almost double between 2012 and 2022. As this is demanding for better, simple to use and affordable screening methods, the Chinese government has elected CRC screening as one of its key focus areas in cancer prevention.

A successful cooperation
In March 2013, BioChain licensed Epigenomics’ methylated Septin9 marker for the blood-based detection of colorectal cancer (CRC). The collaboration was significantly expanded in October 2013 when BioChain acquired an exclusive license to develop and commercialize Septin9 IVD for CRC screening in the Chinese market and took a stake in the company.

Both companies are also working 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 Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@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. and the CFDA for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in Europe. 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.

 

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264498  24.04.2014
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