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Stablepharma and BB-NCIPD Ltd (Bul Bio) sign exclusive supply agreement to produce the world’s first fridge-free Tetanus diphtheria vaccine
Stablepharma Ltd, the Fridge-free Vaccine Company and BB-NCIPD Ltd (Bul Bio) European vaccine manufacturer, are delighted to announce that we have signed a definitive agreement for the exclusive bulk supply and commercialisation of the Tetanus diphtheria vaccine, on September 20th, 2022.
This agreement follows the head of terms signed in 2022 and consolidates the relationship between Stablepharma Ltd and the Bul Bio team. This agreement, in effect means that Stablepharma can progress and lead full development and registration of dry, thermostable versions* of the Tetadif vaccine, a WHO pre-approved vaccine for global distribution.
Roumen Kofinov, MD, General Manager of BB-NCIPD Ltd (Bul Bio) said, “I believe that this agreement is a milestone for all of us, paving the way forward for both companies and fulfilling the guidelines of WHO to bring to mankind thermostable /fridge-free vaccines”.
With this agreement, Bul Bio will exclusively supply the bulk Tetadif vaccine to Stablepharma as well as sharing the necessary regulatory dossiers and files for R&D and regulatory purposes. Stablepharma will have exclusive rights to manufacture and distribute StablevaX™-Td globally. In addition, Stablepharma will own the global marketing authorisation and will be responsible for registration and sales of the fridge-free vaccine. As part of this agreement, Bul Bio will have first right of refusal for certain territories, including the Balkans and NGOs.
Stablepharma Ltd. and BB-NCIPD Ltd (Bul Bio) formed a strategic partnership in 2021 to produce the world’s first fridge-free Tetanus diphtheria (Td) vaccine, StablevaXTM-Td. Most recently, Stablepharma and Bul Bio concluded in-vivo animal challenge studies (i.e. potency tests in animals) for the Tetanus component of the fridge-free Td vaccine, StablevaXTM-Td. The animal potency challenge test results demonstrated that the tetanus component of the StablevaXTM-Td vaccine remains thermostable and as potent as the reference vaccine, after exposure to +45°C for 12 months.
There are currently no fridge-free vaccine solutions on the marketplace. “This is a landmark opportunity for Stablepharma and Bul Bio, as we progress the development and manufacture of the first fridge-free vaccine StablevaX™-Td”, said Özgür Tuncer, CEO & Executive Director of Stablepharma. “By eliminating the need for the cold-chain, fridge-free vaccines could result in substantial health economic savings and expand vaccine access in low-income countries – this in itself is a huge incentive for us to progress our technology and product development with our partners”.
Nick Child, VP and Co-Founder of Stablepharma, stated that the two companies have now consummated a milestone and far-reaching agreement that will enhance the science of vaccines and be a significant benefit to all: “We are all delighted with the outcome of our continued co-operation”.
Stablepharma will work with partners Boyds Consultants https://boydconsultants.com/ to pursue the regulatory requirements for the reformulated Tetanus diphtheria vaccine. “This is another milestone towards achieving our vision of making fridge-free vaccines a reality and, making vaccines accessible to everyone, everywhere”, added Özgür. “In just a short period, we have progressed from a technology company to a product development Biotech, and with our strategic partnerships, we have an exciting future!”
*Several product presentations including vials and pre-filled syringes.
About Stablepharma Ltd :
Stablepharma Ltd is an innovative biotech company developing a range of next generation fridge-free vaccine products. Stablepharma was founded with a simple purpose; to use its novel technology to dramatically improve health outcomes for those adults and children most at risk of death and disability caused by vaccine preventable diseases. StablevaX-M is an adaptable fridge-free technology which offers an extended shelf-life, reduces vaccine wastage and the CO2 footprint of the cold-chain. Stablepharma R&D team have identified up 60 vaccines candidates that could be suitable for StablevaX™ technology to dramatically enhance the performance of existing and new vaccines. www.stablepharma.com.
About Bul Bio
BB-NCIPD Ltd. is a vaccine manufacturer, owned by Ministry of Health of Bulgaria, with over 130 years of history in the manufacture of biopreparations.
The production nomenclature covers more than 600 medicines, divided in two main groups: human medicines and in-vitro diagnostic medicine products.
Bul Bio’s production facilities, vaccines and other drugs comply with the WHO and European Pharmacopoeia requirements. https://bulbio.com/en.html
This agreement follows the head of terms signed in 2022 and consolidates the relationship between Stablepharma Ltd and the Bul Bio team. This agreement, in effect means that Stablepharma can progress and lead full development and registration of dry, thermostable versions* of the Tetadif vaccine, a WHO pre-approved vaccine for global distribution.
Roumen Kofinov, MD, General Manager of BB-NCIPD Ltd (Bul Bio) said, “I believe that this agreement is a milestone for all of us, paving the way forward for both companies and fulfilling the guidelines of WHO to bring to mankind thermostable /fridge-free vaccines”.
With this agreement, Bul Bio will exclusively supply the bulk Tetadif vaccine to Stablepharma as well as sharing the necessary regulatory dossiers and files for R&D and regulatory purposes. Stablepharma will have exclusive rights to manufacture and distribute StablevaX™-Td globally. In addition, Stablepharma will own the global marketing authorisation and will be responsible for registration and sales of the fridge-free vaccine. As part of this agreement, Bul Bio will have first right of refusal for certain territories, including the Balkans and NGOs.
Stablepharma Ltd. and BB-NCIPD Ltd (Bul Bio) formed a strategic partnership in 2021 to produce the world’s first fridge-free Tetanus diphtheria (Td) vaccine, StablevaXTM-Td. Most recently, Stablepharma and Bul Bio concluded in-vivo animal challenge studies (i.e. potency tests in animals) for the Tetanus component of the fridge-free Td vaccine, StablevaXTM-Td. The animal potency challenge test results demonstrated that the tetanus component of the StablevaXTM-Td vaccine remains thermostable and as potent as the reference vaccine, after exposure to +45°C for 12 months.
There are currently no fridge-free vaccine solutions on the marketplace. “This is a landmark opportunity for Stablepharma and Bul Bio, as we progress the development and manufacture of the first fridge-free vaccine StablevaX™-Td”, said Özgür Tuncer, CEO & Executive Director of Stablepharma. “By eliminating the need for the cold-chain, fridge-free vaccines could result in substantial health economic savings and expand vaccine access in low-income countries – this in itself is a huge incentive for us to progress our technology and product development with our partners”.
Nick Child, VP and Co-Founder of Stablepharma, stated that the two companies have now consummated a milestone and far-reaching agreement that will enhance the science of vaccines and be a significant benefit to all: “We are all delighted with the outcome of our continued co-operation”.
Stablepharma will work with partners Boyds Consultants https://boydconsultants.com/ to pursue the regulatory requirements for the reformulated Tetanus diphtheria vaccine. “This is another milestone towards achieving our vision of making fridge-free vaccines a reality and, making vaccines accessible to everyone, everywhere”, added Özgür. “In just a short period, we have progressed from a technology company to a product development Biotech, and with our strategic partnerships, we have an exciting future!”
*Several product presentations including vials and pre-filled syringes.
About Stablepharma Ltd :
Stablepharma Ltd is an innovative biotech company developing a range of next generation fridge-free vaccine products. Stablepharma was founded with a simple purpose; to use its novel technology to dramatically improve health outcomes for those adults and children most at risk of death and disability caused by vaccine preventable diseases. StablevaX-M is an adaptable fridge-free technology which offers an extended shelf-life, reduces vaccine wastage and the CO2 footprint of the cold-chain. Stablepharma R&D team have identified up 60 vaccines candidates that could be suitable for StablevaX™ technology to dramatically enhance the performance of existing and new vaccines. www.stablepharma.com.
About Bul Bio
BB-NCIPD Ltd. is a vaccine manufacturer, owned by Ministry of Health of Bulgaria, with over 130 years of history in the manufacture of biopreparations.
The production nomenclature covers more than 600 medicines, divided in two main groups: human medicines and in-vitro diagnostic medicine products.
Bul Bio’s production facilities, vaccines and other drugs comply with the WHO and European Pharmacopoeia requirements. https://bulbio.com/en.html