SK Bioscience and Sanofi reinforce vaccine R&D partnership

Over tenfold rise in agreement worth than what had been signed in the previous agreement

Signed a KRW 75.5 billion pneumococcal vaccine co-development agreement with Sanofi, totaling at KRW 528.7 billion

The new agreement expands the scope of the agreement the companies had signed for the joint development of GBP410, and will co-invest in Sanofi's production facility expansion

Exported technology for influenza vaccine production platform in 2018...received KRW 165.5 billion in payment

SK Bioscience has expanded the scope of its vaccine development partnership with global pharmaceutical giant Sanofi.

 

The goal is to develop a next-generation vaccine that is more advanced than the existing jointly developed pneumococcal protein-conjugate vaccine.

 

The expanded agreement is more than 10 times larger in total value than the original agreement signed by the two companies a decade ago.

 

When including the technology export agreement that SK Bioscience signed with Sanofi in 2018, SK Bioscience will receive more than KRW 160 billion from Sanofi.

 

On the 23rd, SK Bioscience and Sanofi announced that they have entered into an agreement to jointly develop a next-generation pneumococcal protein-conjugate vaccine for infants, children, and adults that will provide broader protection than commercially available products.

 

The agreement expands the scope of the companies' existing collaboration to develop and commercialize GBP410, a 21-valent pneumococcal protein conjugate vaccine candidate.

 

In 2014, SK Bioscience signed an agreement with Sanofi to co-develop and commercialize a next-generation pneumococcal vaccine.

 

Under the expanded agreement, the two companies plan to develop an innovative next-generation pneumococcal vaccine that is more advanced than the 21-valent vaccine.

 

Under the new project, SK Bioscience will receive an upfront payment of EUR 50 million from Sanofi.

 

Additional milestone payments will be made upon achievement of milestones until development is completed.

 

The total value of the agreement is EUR 350 million (approximately USD 528.7 billion).

 

R&D costs for the vaccine will be shared equally by the two companies.

 

All costs related to commercialization will be borne by Sanofi.

 

Upon commercialization, SK Bioscience will be responsible for sales of the vaccine in Korea, and Sanofi will be responsible for global sales.

 

Revenue will be shared in a defined ratio based on product sales.

 

Previously, SK Bioscience and Sanofi signed an agreement in 2014 to co-develop and market a next-generation pneumococcal vaccine with an upfront payment of USD 23 million (approximately KRW 25.6 billion).

 

The total worth of the agreement, including upfront technology fees and milestones, was $45 million.

 

The worth of the expanded agreement is more than 10 times larger in total value than the previous agreement signed by the two companies 10 years ago.

 

In terms of down payment, this agreement is approximately 3 times larger than the previous agreement.

 

This is the 10th year of R&D collaboration between the 2 companies and further strengthens their partnership.

 

SK Bioscience-Sanofi R&D agreement (Source: FSS, SK Bioscience)

In 2018, SK Bioscience also exported its cell culture-based high-efficiency influenza (flu) vaccine production platform to Sanofi.

 

The contract is worth USD 155 million, including a USD 15 million upfront payment and a USD 20 million milestone payment upon completion of the technology transfer.

 

The flu vaccine production platform agreement was terminated at the end of 2021 with Sanofi returning the rights.

 

However, SK Bioscience has no obligation to return the upfront payment of USD 35 million (approximately KRW 40 billion).

 

SK Bioscience had received all the payments for the GBP410 agreement signed in 2014.

 

Including the payments from the Sanofi technology export agreement and this expansion agreement, SK Bioscience's total payments from Sanofi amount to KRW 165.5 billion.

 

Last year, SK Bioscience and Sanofi also jointly invested in the expansion of manufacturing facilities for the commercialization of GBP410.

 

In October 2023, SK Bioscience decided to invest KRW 81.5 billion to expand its vaccine production facility in Korea, the Andong L House.

 

The investment amount, which will be decided by SK Bioscience's board of directors, will be combined with Sanofi's co-investment to build a new production facility of approximately 4,200㎡(1,300 pyung) at Andong L House.

 

The expanded production facility will be utilized for the production of GBP410, which is being co-developed by the two companies.

 

The facility is expected to be completed by May next year.

 

SK바이오사이언스 안동L하우스 전경.

 

(자료: SK바이오사이언스

GBP410 is currently in a Phase III clinical trial.

 

GBP410 entered a multi-country Phase III clinical trial last week and started administration first subject.

 

The GBP410 multinational Phase III study will compare the immunogenicity and safety of GBP410 to licensed pneumococcal vaccines after up to 4 doses in more than 7,700 infants, children, and adolescents aged 6 weeks to 17 years.

 

SK Bioscience and Sanofi confirmed the efficacy and safety of GBP410 in a Phase II clinical trial in June last year.

 

The study, which included an initial and booster dose of GBP410 and a control vaccine (Prevenar 13) in 140 children aged 12 to 15 months and 712 infants and toddlers aged 42 to 89 days, confirmed that the immunogenicity of GBP410 and the control vaccine was equivalent.

 

In terms of safety, no serious vaccine-related adverse events were reported in the GBP410 arm.

 

Equivalent immunogenicity and safety to the control vaccine were also demonstrated when coadministered with other recommended vaccines for infants and children, including tetanus, diphtheria, pertussis, polio, and Haemophilus influenza type B vaccines.

 

GBP410 is the first vaccine candidate to enter Phase III clinical trials in infants and children to include more than 20 serotypes.

 

With this, SK Bioscience believes GBP410 will contribute significantly to reducing the frequency of invasive pneumococcal disease (IPD) in infants and young children.

 

 “The agreement expansion between SK and Sanofi is based on the high success potential of the 21-valent vaccine, positive market outlook, and mutual trust,” said Jae-Yong Ahn, President and CEO of SK Bioscience.

 

”As a Korean vaccine and bio leader, we will do our best to secure vaccine sovereignty and the successful launch of a blockbuster vaccine.