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29.02.2016 08:00:06
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DGAP-News: Formycon AG
DGAP-News: Formycon AG: Formycon discloses details on second pipeline product - FYB203 is a biosimilar for Eylea (aflibercept)
1. With its Eylea* biosimilar Formycon is solidifying its leading position in ophthalmologic follow-on products 2. Global development programs for biosimilars aflibercept (FYB203) and ranibizumab (FYB201) 3. Development pipeline covers the two most important and best-selling medications in the field of ophthalmology
Munich - Formycon AG today has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea (aflibercept). This comprises the common development pipeline with the two most important and best-selling medications in the field of ophthalmology, FYB201 (biosimilar candidate for Lucentis**) and FYB203.
Eylea and Lucentis are used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Lucentis generated revenues of approximately USD 3.5 billion in 2015, while Eylea achieved an estimated market volume of more than USD 4 billion. Together, both products represent almost the entire global market volume for intraocular anti-VEGF treatments, one of the fastest growing therapeutic areas on the pharmaceutical market.
Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.
Dr. Carsten Brockmeyer, CEO of Formycon AG: "The development of biosimilars for Lucentis and Eylea has made us pioneers in the area of opthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage. It is our goal to launch our biosimilars on the market at day one after the patent on the reference product expires."
"The anticipated significant market growth in ophthalmology means that the provision of safe and high quality medications in this area poses a significant challenge for the global health care systems. Through our biosimilars, we are striving to make a considerable contribution to the supply of as many patients as possible worldwide with these important pharmaceutical products", added Dr. Nicolas Combé, CFO of Formycon AG.
* Eylea is a registered trademark of Regeneron Pharmaceuticals Inc. ** Lucentis is a registered trademark of Genentech Inc.
About Formycon: Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon's specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About bioeq: bioeq GmbH was established in March 2014 and is funded by the Strüngmann Group (Santo Holding) and by Polpharma, a leading Polish pharmaceutical company. bioeq is active in the development of biosimilars in compliance with standards required for approval and distribution in the EU, US and other highly regulated markets. Starting from early stage development projects licensed from internationally renowned partners or cell lines stemming from affiliated companies, bioeq conducts development programs up to clinical development and registration. bioeq's pipeline comprises several of the so-called "third wave" biosimilars, for which patent protection is due to expire within the next decade. bioeq's management team combines expert scientists and senior management with a skill set spanning from early stage development through to commercialization of complex molecules and biosimilars.
About biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.
Contact: Thorsten Schüller Corporate Communications and Investor Relations Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg/Germany phone +49 (0) 89 - 86 46 67 150 fax + 49 (0) 89 - 86 46 67 110 Thorsten.schueller@formycon.com // www.formycon.com
Disclaimer: This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety and patent litigation. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
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29.02.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP 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: Formycon AG Fraunhoferstraße 15 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
440819 29.02.2016
DGAP-News: Formycon AG / Key word(s): Research Update/Study
Formycon AG: Formycon discloses details on second pipeline product - FYB203
is a biosimilar for Eylea (aflibercept)
29.02.2016 / 08:00
The issuer is solely responsible for the content of this announcement.
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Press release // February 29, 2016
Formycon discloses details on second pipeline product - FYB203 is a
biosimilar for Eylea (aflibercept)
1. With its Eylea* biosimilar Formycon is solidifying its leading position in ophthalmologic follow-on products 2. Global development programs for biosimilars aflibercept (FYB203) and ranibizumab (FYB201) 3. Development pipeline covers the two most important and best-selling medications in the field of ophthalmology
Munich - Formycon AG today has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea (aflibercept). This comprises the common development pipeline with the two most important and best-selling medications in the field of ophthalmology, FYB201 (biosimilar candidate for Lucentis**) and FYB203.
Eylea and Lucentis are used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Lucentis generated revenues of approximately USD 3.5 billion in 2015, while Eylea achieved an estimated market volume of more than USD 4 billion. Together, both products represent almost the entire global market volume for intraocular anti-VEGF treatments, one of the fastest growing therapeutic areas on the pharmaceutical market.
Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.
Dr. Carsten Brockmeyer, CEO of Formycon AG: "The development of biosimilars for Lucentis and Eylea has made us pioneers in the area of opthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage. It is our goal to launch our biosimilars on the market at day one after the patent on the reference product expires."
"The anticipated significant market growth in ophthalmology means that the provision of safe and high quality medications in this area poses a significant challenge for the global health care systems. Through our biosimilars, we are striving to make a considerable contribution to the supply of as many patients as possible worldwide with these important pharmaceutical products", added Dr. Nicolas Combé, CFO of Formycon AG.
* Eylea is a registered trademark of Regeneron Pharmaceuticals Inc. ** Lucentis is a registered trademark of Genentech Inc.
About Formycon: Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon's specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About bioeq: bioeq GmbH was established in March 2014 and is funded by the Strüngmann Group (Santo Holding) and by Polpharma, a leading Polish pharmaceutical company. bioeq is active in the development of biosimilars in compliance with standards required for approval and distribution in the EU, US and other highly regulated markets. Starting from early stage development projects licensed from internationally renowned partners or cell lines stemming from affiliated companies, bioeq conducts development programs up to clinical development and registration. bioeq's pipeline comprises several of the so-called "third wave" biosimilars, for which patent protection is due to expire within the next decade. bioeq's management team combines expert scientists and senior management with a skill set spanning from early stage development through to commercialization of complex molecules and biosimilars.
About biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.
Contact: Thorsten Schüller Corporate Communications and Investor Relations Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg/Germany phone +49 (0) 89 - 86 46 67 150 fax + 49 (0) 89 - 86 46 67 110 Thorsten.schueller@formycon.com // www.formycon.com
Disclaimer: This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety and patent litigation. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
---------------------------------------------------------------------------
29.02.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP 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: Formycon AG Fraunhoferstraße 15 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
440819 29.02.2016
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