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
---------------------------------------------------------------------------
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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Archives
27. October 2013
Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics and BioChain sign agreement for broad strategic collaboration in China
02. October 2013
Epigenomics AG: Epigenomics signs joint commercialization agreement for Epi proColon(R) in North America with Polymedco
|
Epigenomics AG / Key word(s): Agreement 02.10.2013 / 08:00 – Companies to join efforts in commercialization of Epi proColon(R) – Epigenomics to provide manufacturing, medical, regulatory and strategic marketing – Polymedco, the US leader in CRC screening products, to contribute logistics, sales, marketing and customer support Berlin, Germany, and U.S.A., October 2, 2013– Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, announced today that it has entered into a joint commercialization agreement with Polymedco Inc., a leading provider of colorectal cancer tests in North America. Both companies will jointly commercialize Epi proColon(R), Epigenomics’ blood-based test for colorectal cancer (CRC) screening, in North America. Under the terms of the agreement, Polymedco will deploy its CRC dedicated sales force and technical support staff, administration, logistics and other support functions to ensure the optimum market introduction and roll-out of Epi proColon(R) once the test is potentially approved by the US Food and Drug Administration. Both parties will work jointly on the marketing, launch and development strategies and with key payers to obtain favorable reimbursement coverage. Epigenomics will retain the responsibility to manufacture the product and to support it from the medical and regulatory point of view, including activities necessary to achieve inclusion in major cancer screening guidelines post approval. A working group comprised of representatives of both companies will oversee the launch and commercial roll-out and engage in activities necessary to ensure the commercial success of the product once it becomes available to the market. The companies agreed to a combined transfer price and profit sharing agreement subject to minimum annual sales of test kits from Epigenomics to Polymedco. Thomas Taapken, CEO and CFO of Epigenomics, commented: ‘We are excited to enter into this joint commercialization agreement with Polymedco. The significant know-how and commitment of Polymedco to the CRC screening space will accelerate our commercial roll-out in North America. Being able to leverage the existing and well-functioning infrastructure of Polymedco will mean a significant time and resource advantage for Epigenomics between now and market launch of Epi proColon(R).’ Noel Doheny, CEO of Epigenomics’ US subsidiary, commented: ‘Polymedco’s commitment to the CRC screening space will accelerate our commercial roll-out in North America and will mean a significant time and resource advantage for Epigenomics in the launch of Epi proColon(R). Being able to work with the market leader in CRC screening products in the US will enable us to efficiently target the right customers in order to increase screening compliance among those 35 million people in the US who today are not compliant to CRC screening.’ Polymedco is the largest provider of CRC screening tests in North America, with more than USD50m in annual sales for its cancer diagnostics products. The company’s product range includes multiple platforms for automated and manual Fecal Immunochemical Test (FIT) solutions for CRC testing. It has an established customer base of more than 1500 laboratories, of which 100 are major medical centers. Polymedco’s staff devoted to the joint collaboration is comprised of more than 50 specialized sales and support experts, which target exclusively laboratories and medical centers engaged in cancer screening and diagnostics. Drew Cervasio, President and CEO of Polymedco, commented: ‘We are very pleased to partner with Epigenomics on the commercialization of Epi proColon(R) and thereby to expand our dominant position in the colon cancer screening market. We believe that the two complementary tests, Epi proColon(R) and FIT testing solutions, will drive the highest patient compliance for CRC screening. Our joint mission is to screen the entire population over 50 years old on a regular basis and offering these two different solutions will help to achieve this. This process will lead to early detection, better patient care and saving our healthcare system billions of dollars with the reduction of late-stage treatment’ – Ends – Contact Epigenomics AG Antje Zeise, Manager IR | PR For US press inquiries: Epigenomics, Inc. 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 in development 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 Polymedco Polymedco Inc. is a leading manufacturer, marketer, and distributer in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits and devices that are specialized in hematology and cancer. We are a world leader in non-invasive colorectal cancer screening technology, providing the new standard of care with the OC-Auto(R) and OC-Light(R) product line. 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 02.10.2013 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. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| 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 News | DGAP News-Service |
|
|
| 233011 02.10.2013 |
01. October 2013
Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics signs joint commercialization agreement for Epi proColon(R) in North America with Polymedco
Epigenomics AG / Key word(s): Agreement
02.10.2013 00:28
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, October 01, 2013 - Epigenomics AG (ISIN: DE000A1K0516)
announces that it has entered into a joint commercialization agreement with
Polymedco Inc. Both companies will jointly commercialize Epi proColon(R),
Epigenomics' blood-based test for colorectal cancer (CRC) screening, in
North America.
Under the terms of the agreement, Polymedco will deploy its CRC dedicated
sales force and technical support staff, administration, logistics and
other support functions to ensure the optimum market introduction and
roll-out of Epi proColon(R) once the test is potentially approved by the US
Food and Drug Administration. Both parties will work jointly on the
marketing, launch and development strategies and with key payers to obtain
favorable reimbursement coverage. Epigenomics will retain the
responsibility to manufacture the product and to support it from the
medical and regulatory point of view, including activities necessary to
achieve inclusion in major cancer screening guidelines post approval. A
working group comprised of representatives of both companies will oversee
the launch and commercial roll-out and engage in activities necessary to
ensure the commercial success of the product once it becomes available to
the market. The companies agreed to a combined transfer price and profit
sharing agreement subject to minimum annual sales of test kits from
Epigenomics to Polymedco.
Polymedco is the largest provider of CRC screening tests in North America,
with more than USD 50m in annual sales for its cancer diagnostics products
and an established customer base of more than 1500 laboratories. The
significant know-how and commitment of Polymedco to the CRC screening space
will accelerate the commercial roll-out of Epi proColon(R) in North America
and mean a significant time and resource advantage for Epigenomics between
now and market launch of the product.
- 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.
02.10.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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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30. September 2013
Epigenomics AG: Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG mit dem Ziel der europaweiten Verbreitung
Epigenomics AG / Veröffentlichung der Gesamtzahl der Stimmrechte
30.09.2013 10:30
Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG, übermittelt durch die DGAP - ein Unternehmen der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
---------------------------------------------------------------------------
Hiermit teilt die Epigenomics AG mit, dass die Gesamtzahl der Stimmrechte
am Ende des Monats September 2013 insgesamt 12011814 Stimmrechte beträgt.
30.09.2013 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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30. August 2013
Epigenomics AG: Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics AG issues EUR 500,000 in convertible bonds to YA Global Master SPV Ltd.
Epigenomics AG / Key word(s): Corporate Action
30.08.2013 15:40
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, August 30, 2013 - Epigenomics AG (ISIN: DE000A1K0516)
announces that upon registration of the conditional capital of the Company
today successfully completed the issuance of convertible bonds with a
nominal amount of EUR 500,000. These convertible bonds constitute the first
tranche of a total issuance of up to EUR 5m guaranteed by an agreement
between YA Global Master SPV Ltd. ('YA Global') and the Company. Following
successful conversion or repayment of already issued tranches, the
issuance of possible further tranches will be subject to future
discretionary decisions by the Executive Board of the Company.
Excluding pre-emptive rights to existing shareholders, the convertible
bonds will be issued to YA Global exclusively at a subscription price of
95% of the nominal amount. The bonds carry no interest, have a term until
May 29, 2014 and are convertible into shares of Epigenomics immediately
upon their issuance at the full discretion of the bearer of the bonds. The
conversion price equals the average trading price of Epigenomics shares
during a 5 day period prior to the time of conversion less a 5% discount,
but cannot be lower than EUR 2.10.
Further details regarding the terms and conditions in connection with the
issuance of convertible bonds according to the agreement with YA Global
were announced by the ad hoc notification dated August 18, 2013.
- 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.
30.08.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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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19. August 2013
Epigenomics AG: Epigenomics AG secures financing of up to EUR 5m
|
Epigenomics AG / Key word(s): Corporate Action 19.08.2013 / 08:30 Berlin, Germany, and U.S.A., August 19, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, announced that it has entered into an agreement with YA Global Master SPV Ltd. (‘Yorkville’) through which it secured a convertible bond financing for up to EUR 5m. Under the terms of the agreement, YA Global Master SPV Ltd., over a period of up to two years, is obliged to purchase convertible notes with a total nominal amount of EUR 5m at a purchase price of 95% of the nominal amount. Epigenomics may issue the convertible notes in tranches of EUR 500,000 each at its sole discretion. A tranche comprises 500 convertible notes in the form of bearer bonds each with a nominal value of EUR 1,000 and transferrable only upon approval of Epigenomics. The convertible notes will only be issued and may only be traded in lots with a total nominal value of EUR 125,000.
The bonds carry no interest, have a term of nine months and are convertible into shares of Epigenomics immediately upon issuance at the discretion of the bearer of the bonds. The conversion price equals the average trading price of Epigenomics shares during a 5 day period prior to the time of conversion less a 5% discount, but cannot be lower than 80% of the prevailing share price at the time of the issuance of the convertible bonds. To the extent permitted by the existing authorization of Epigenomics’ General Shareholders’ Meeting, the bonds will be issued without pre-emptive rights to existing shareholders. Currently Epigenomics has the authorization to issue convertible bonds that may be converted into up to 1,196,783 shares without offering those pre-emptive rights. Further convertible bonds resulting in the issuance of up to an additional 3,933,217 shares may be issued with pre-emptive rights to existing shareholders. Epigenomics expects that the proceeds from the issuance of these bonds will help to fund the business operations up to and possibly beyond the FDA approval of its lead product Epi proColon(R), a blood-based test for the detection of colorectal cancer. Dr. Thomas Taapken, CEO/CFO of Epigenomics commented: ‘This positive agreement with Yorkville provides us with a flexible financing tool that will help to improve the financial situation of the company ahead of the FDA approval decision for our lead product Epi proColon(R), which we still await in 2013. We will consider alternative financing options in parallel.’ Saad Gilani, Head-Healthcare Group at Yorkville Advisors, commented: ‘We are very excited to be investing in Epigenomics and working with its accomplished management team in its quest to develop and market easy to administer blood-based diagnostic tests for early detection of cancer.’ – Ends – Contact Epigenomics AG Antje Zeise, Manager IR | PR For US press inquiries: Epigenomics, Inc. 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 in development 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. 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 19.08.2013 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. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| 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 News | DGAP News-Service |
|
|
| 226388 19.08.2013 |