Neovacs and Centurion Pharma continue their collaboration in Lupus based on the results of the Phase IIb trial with IFNalpha Kinoid

PRESS RELEASE · PRESS RELEASE · PRESS RELEASE

Neovacs and Centurion Pharma continue their collaboration in Lupus
based on the results of the Phase IIb trial with IFNalpha Kinoid

Paris and Boston, December 11th 2018 – 7:30 am CET – Neovacs (Euronext Growth Paris: ALNEV), leader in the field of active immune therapy for the treatment of autoimmune-diseases, confirms the decision of Centurion Pharma to pursue the partnership on the basis of the licensing agreement signed between both companies in July 2017 for the development of IFNalpha Kinoid in the indication Lupus (SLE). This is the consequence of the analysis and validation by Centurion Pharma of the results of the Phase IIb trial in this indication. Through this contract Centurion Pharma has acquired an exclusive commercial license for Turkey.

“The introduction of IFNalpha Kinoid for the treatment of Lupus in Turkey is part of our corporate strategy to bring innovative treatment in the field of healthcare into our country, which will reach 90 mio inhabitants in a few years” declares Ersin M. Erfa, CEO of Centurion Pharma.

In this context, Centurion Pharma could take specific initiatives towards health authorities in Turkey. According to Turkish regulations an import and marketing authorization on a name patient basis could be obtained, once such marketing authorization is obtained in another country.

A status of ODD (Orphan Drug Designation) is actually being prepared for filing in South Korea. The approval of such a status would allow an accelerated submission for registration.

On a global basis Neovacs is actually preparing the protocol of the Phase III trial and working on the strategies for registration of IFNalpha Kinoid.

The agreement with Centurion Pharma has foreseen a global payment of 6 mio € to Neovacs. A first payment has been made at the signature of this exclusive license agreement with Centurion Pharma in 2017. Further payments are foreseen according to defined clinical and regulatory milestones. Neovacs will also receive royalties based on net sales of IFNalpha Kinoid in Turkey.

About Centurion Pharma

Since 1979, Centurion Pharma has been serving the Turkish market with therapeutic care products for the treatment of specific and rare diseases encountered in Turkey as well as biological, biotechnological and hospital products through collaborations with leading pharmaceutics of the world. Centurion Pharma head office is located in Istanbul and the Company expanded its production activities in Ankara for biosimilars, vaccines, orphan drugs and hospital generics. The R&D activities are located at the Centurion Pharma production area with a main focus on specific therapeutic areas. The company will expand the business for neighborhood countries like Middle East, CIS, Africa and Balkan countries after the start of local production.

http://www.centurion.com.tr/

About Neovacs
Listed on Euronext Growth since 2010, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company’s proprietary technology for inducing a polyclonal immune response (covered by four patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNalpha Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases. www.neovacs.fr

Contacts

NEOVACS – Corporate Communication & Investor Relations
Charlène Masson
+33 1 53 10 93 00
cmasson@neovacs.com

NEWCAP- Media
Annie-Florence Loyer
+33 1 44 71 00 12 / + 33 6 88 20 35 59
afloyer@newcap.fr
Léa Jacquin
+33 1 44 71 20 41 / +33 6 58 14 84 66
ljacquin@newcap.fr

Attachment

Neovacs and Centurion Pharma continue their collaboration in Lupus based on the results of the Phase IIb trial with IFNalpha Kinoid

PRESS RELEASE · PRESS RELEASE · PRESS RELEASE

Neovacs and Centurion Pharma continue their collaboration in Lupus
based on the results of the Phase IIb trial with IFNalpha Kinoid

Paris and Boston, December 11th 2018 – 7:30 am CET – Neovacs (Euronext Growth Paris: ALNEV), leader in the field of active immune therapy for the treatment of autoimmune-diseases, confirms the decision of Centurion Pharma to pursue the partnership on the basis of the licensing agreement signed between both companies in July 2017 for the development of IFNalpha Kinoid in the indication Lupus (SLE). This is the consequence of the analysis and validation by Centurion Pharma of the results of the Phase IIb trial in this indication. Through this contract Centurion Pharma has acquired an exclusive commercial license for Turkey.

“The introduction of IFNalpha Kinoid for the treatment of Lupus in Turkey is part of our corporate strategy to bring innovative treatment in the field of healthcare into our country, which will reach 90 mio inhabitants in a few years” declares Ersin M. Erfa, CEO of Centurion Pharma.

In this context, Centurion Pharma could take specific initiatives towards health authorities in Turkey. According to Turkish regulations an import and marketing authorization on a name patient basis could be obtained, once such marketing authorization is obtained in another country.

A status of ODD (Orphan Drug Designation) is actually being prepared for filing in South Korea. The approval of such a status would allow an accelerated submission for registration.

On a global basis Neovacs is actually preparing the protocol of the Phase III trial and working on the strategies for registration of IFNalpha Kinoid.

The agreement with Centurion Pharma has foreseen a global payment of 6 mio € to Neovacs. A first payment has been made at the signature of this exclusive license agreement with Centurion Pharma in 2017. Further payments are foreseen according to defined clinical and regulatory milestones. Neovacs will also receive royalties based on net sales of IFNalpha Kinoid in Turkey.

About Centurion Pharma

Since 1979, Centurion Pharma has been serving the Turkish market with therapeutic care products for the treatment of specific and rare diseases encountered in Turkey as well as biological, biotechnological and hospital products through collaborations with leading pharmaceutics of the world. Centurion Pharma head office is located in Istanbul and the Company expanded its production activities in Ankara for biosimilars, vaccines, orphan drugs and hospital generics. The R&D activities are located at the Centurion Pharma production area with a main focus on specific therapeutic areas. The company will expand the business for neighborhood countries like Middle East, CIS, Africa and Balkan countries after the start of local production.

http://www.centurion.com.tr/

About Neovacs
Listed on Euronext Growth since 2010, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company’s proprietary technology for inducing a polyclonal immune response (covered by four patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNalpha Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases. www.neovacs.fr

Contacts

NEOVACS – Corporate Communication & Investor Relations
Charlène Masson
+33 1 53 10 93 00
cmasson@neovacs.com

NEWCAP- Media
Annie-Florence Loyer
+33 1 44 71 00 12 / + 33 6 88 20 35 59
afloyer@newcap.fr
Léa Jacquin
+33 1 44 71 20 41 / +33 6 58 14 84 66
ljacquin@newcap.fr

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