- First submission for product from the new Biotest Next Level production facility
- Approval expected in 4th quarter
- Signature of first licensing agreement
DREIEICH, Germany I April 07, 2022 IBiotest AG announced today that the marketing authorisation application for the Biotest development product IgG Next Generation in the so-called decentralised procedure (DCP) was submitted in Germany and Austria by 31 March 2022. IgG Next Generation is the first product to be produced in Biotest’s new manufacturing facility Biotest Next Level (BNL).
The marketing authorisation application covers the biochemical-pharmaceutical-technical part, as well as the preclinical and clinical studies in the indications Primary Immunodeficiency Diseases (PID) and chronic Primary Immune Thrombocytopenia (ITP).
“We are very proud that we have managed the balancing act between commissioning a new production facility and dossier preparation for our development product IgG Next Generation so well. Thanks to the tireless efforts and great team spirit of the employees in almost all departments of the company, we managed to realise the submission on schedule at the end of the quarter,” said Christine Piasek, responsible Head of Regulatory Affairs / Development Products.
The dossier is now undergoing an assessment process by the authorities. In case of a positive assessment by the authorities, Biotest expects approval in the 4th quarter.
IgG Next Generation is manufactured in an innovative production process and is the main product of the new production facility “Biotest Next Level”, which was successfully accepted by the Darmstadt Regional Council in July 2021. This new production facility, which uses state-of-the-art technologies, represents Biotest’s increased commitment to the global immunoglobulin market.
Because of the submission, Biotest was able to announce the signature of a licensing agreement for its novel immunoglobulin (IgG Next Generation) with the Saudi Arabian company Pharma Pharmaceutical Industries (PPI).
Based on this agreement and with help of Biotest’s immunoglobulin expertise and technology, PPI will be able to introduce in Saudi Arabia the first local polyvalent intravenous immunoglobulin. The agreement is based on an upfront payment for the license, consists of three milestones starting from the contract signature and a 10 years contract manufacturing and supply agreement. Biotest will produce the bulk product in the new BNL fractionation plant. The launch in the Kingdom of Saudi Arabia is expected in 2023.
“This is a historical moment for Biotest as we have signed a contract that is giving immediately the first revenue for our new product coming from our new plant. Moreover, this is the recognition of the quality of our manufacturing process and scientific know-how as well as the confirmation of the importance to expand our product portfolio, our capacity and our commercial network in the immunoglobulin market,” said Enrico D’Aiuto, Senior Vice President of Biotest Global Sales & Marketing. “With the signature of this long-term collaboration, we confirm Biotest’s historical commercial presence and heritage in the Middle East region and in Saudi Arabia, where Biotest products have been available for years to help the local patient population.” “Thanks to PPI’s management long-term view, starting from 2023 there will be another therapeutic option available: the first local immunoglobulin, in a period in which we have to face a critical shortage for plasma proteins all over the world due to the impact of COVID-19 on plasma collection” concluded Niklas Rorarius, Regional Director Middle East and Gulf.
About IgG Next Generation
IgG Next Generation is a newly developed polyvalent immunoglobulin preparation for intravenous administration from human blood plasma. It will be the first marketed product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources.
The results of the successfully completed clinical trials (PID, ITP) were submitted together to the regulatory authorities in Germany and Austria. After the positive evaluation of the authorities and the approval, IgG Next Generation can be marketed for additional indications. This applies in particular to the treatment of patients due to secondary immune defects, for example due to chronic lymphocytic leukemia, multiple myeloma, after hemotopetic stem cell transplantation, and as immunomodulatory therapy in Guillain-Barree syndrome (GBS), Kawasaki-Syndrom, multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP).
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,000 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
SOURCE: Biotest
Post Views: 226
- First submission for product from the new Biotest Next Level production facility
- Approval expected in 4th quarter
- Signature of first licensing agreement
DREIEICH, Germany I April 07, 2022 IBiotest AG announced today that the marketing authorisation application for the Biotest development product IgG Next Generation in the so-called decentralised procedure (DCP) was submitted in Germany and Austria by 31 March 2022. IgG Next Generation is the first product to be produced in Biotest’s new manufacturing facility Biotest Next Level (BNL).
The marketing authorisation application covers the biochemical-pharmaceutical-technical part, as well as the preclinical and clinical studies in the indications Primary Immunodeficiency Diseases (PID) and chronic Primary Immune Thrombocytopenia (ITP).
“We are very proud that we have managed the balancing act between commissioning a new production facility and dossier preparation for our development product IgG Next Generation so well. Thanks to the tireless efforts and great team spirit of the employees in almost all departments of the company, we managed to realise the submission on schedule at the end of the quarter,” said Christine Piasek, responsible Head of Regulatory Affairs / Development Products.
The dossier is now undergoing an assessment process by the authorities. In case of a positive assessment by the authorities, Biotest expects approval in the 4th quarter.
IgG Next Generation is manufactured in an innovative production process and is the main product of the new production facility “Biotest Next Level”, which was successfully accepted by the Darmstadt Regional Council in July 2021. This new production facility, which uses state-of-the-art technologies, represents Biotest’s increased commitment to the global immunoglobulin market.
Because of the submission, Biotest was able to announce the signature of a licensing agreement for its novel immunoglobulin (IgG Next Generation) with the Saudi Arabian company Pharma Pharmaceutical Industries (PPI).
Based on this agreement and with help of Biotest’s immunoglobulin expertise and technology, PPI will be able to introduce in Saudi Arabia the first local polyvalent intravenous immunoglobulin. The agreement is based on an upfront payment for the license, consists of three milestones starting from the contract signature and a 10 years contract manufacturing and supply agreement. Biotest will produce the bulk product in the new BNL fractionation plant. The launch in the Kingdom of Saudi Arabia is expected in 2023.
“This is a historical moment for Biotest as we have signed a contract that is giving immediately the first revenue for our new product coming from our new plant. Moreover, this is the recognition of the quality of our manufacturing process and scientific know-how as well as the confirmation of the importance to expand our product portfolio, our capacity and our commercial network in the immunoglobulin market,” said Enrico D’Aiuto, Senior Vice President of Biotest Global Sales & Marketing. “With the signature of this long-term collaboration, we confirm Biotest’s historical commercial presence and heritage in the Middle East region and in Saudi Arabia, where Biotest products have been available for years to help the local patient population.” “Thanks to PPI’s management long-term view, starting from 2023 there will be another therapeutic option available: the first local immunoglobulin, in a period in which we have to face a critical shortage for plasma proteins all over the world due to the impact of COVID-19 on plasma collection” concluded Niklas Rorarius, Regional Director Middle East and Gulf.
About IgG Next Generation
IgG Next Generation is a newly developed polyvalent immunoglobulin preparation for intravenous administration from human blood plasma. It will be the first marketed product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources.
The results of the successfully completed clinical trials (PID, ITP) were submitted together to the regulatory authorities in Germany and Austria. After the positive evaluation of the authorities and the approval, IgG Next Generation can be marketed for additional indications. This applies in particular to the treatment of patients due to secondary immune defects, for example due to chronic lymphocytic leukemia, multiple myeloma, after hemotopetic stem cell transplantation, and as immunomodulatory therapy in Guillain-Barree syndrome (GBS), Kawasaki-Syndrom, multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP).
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,000 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
SOURCE: Biotest
Post Views: 226
