2021. 12. 24
SK-Novavax amended the Collaboration and License agreement for contract manufacturing of ‘NVX-CoV2373.’
SK will receive a fee from manufacturing drug substance
SK acquired non-exclusive rights of the product in Thailand and Vietnam
SK recognized worldwide for manufacturing and quality control, which leads to a global hub for vaccine manufacturing
SK bioscience has reached to an agreement to extend manufacturing of a COVID-19 vaccine. By having confirmed its elevated status in CMO market through a successful contract, SK bioscience has also provided its goal of becoming a hub for global vaccine manufacturing.
SK bioscience (CEO Jae-Yong Ahn) announced on December 24th that the company has extended both contract manufacturing and license agreements for drug substance production and global distribution of Novavax’ COVID-19 vaccine candidate, ´NVX-CoV2373.’
Under the agreement, three of nine drug substance production facilities will be utilized for manufacturing NVX-CoV2373 at L-House, vaccine plant in Andong, South Korea until the end of 2022.
According to the amended collaboration agreement, SK bioscience will receive a fee incentive for drug product sales and a fee for drug substance production from Novavax, and secure additional revenues from direct sales in Korea, Thailand and Vietnam.
SK bioscience will receive a service fee for the production volume supplied to Novavax. Also, SK bioscience will receive a fee incentive related to sales when Novavax sells drug product incorporating drug substance that is produced from one of L-House’s drug substance manufacturing facilities.
SK bioscience also can promote separate contracts in South Korea, Thailand, and Vietnam by acquiring rights to supply and commercialize NVX-CoV2373 produced in Andong, in these countries.
SK bioscience estimates it will receive additional revenues in sales, including a service fee of about 200 billion KRW based on the expected production volume of the drug substance.
SK bioscience has been manufacturing NVX-CoV2373 including both drug product and drug substance after signing a license agreement in February 2021, following execution of a contract manufacturing agreement in August 2020. SK bioscience has completed all the process for commercial manufacturing of NVX-CoV2373 through technology transfer of the protein-based recombinant nanoparticle manufacturing and production technology.
NVX-CoV2373 was developed using a well-understood adjuvanted recombinant nanoparticle platform. The same platform has been used for development of current influenza (flu), hepatitis B, and cervical cancer vaccines, for example. The vaccine is stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it can be distributed through the current vaccine supply network without thawing at inoculation stage.
NVX-CoV2373 also demonstrated high efficacy in Novavax’ pivotal Phase 3 PREVENT-19 trial.
Novavax announced that NVX-CoV2373 demonstrated 90% efficacy overall in its PREVENT-19 trial, which was conducted in the U.S. and Mexico with nearly 30,000 participants over the age of 18. In terms of safety, most of the adverse reactions that occurred after injection were mild or moderate.
Novavax is conducting an extension of its Phase 3 PREVENT-19 trial for up to 3,000 adolescents between the ages of 12 to 17 in the U.S. to extend the vaccination age. Also, Novavax showed the data that antibody titers with a booster dose of NVX-CoV2373 after 6 months from two initial shots of the same vaccine, were increased by 4.6 times.
In addition, a recent study conducted by Novavax has confirmed the immune response of NVX-CoV2373 to Omicron and other variants. Antibody titers against the Omicron variant was 9.3 times higher and the Delta variant was 11.1 times higher with a booster dose after 6 months from two initial shots of the same vaccine.
Stanley Erck, CEO of Novavax said ”SK bioscience and the Korean government have been significant partners with Novavax to ensure broad access of our COVID-19 vaccine to the citizens of South Korea and beyond. This strategic partnership helps to further expand our global network for commercialization of high-quality product and contributes to our expected 2 billion annual doses in global manufacturing capacity across all partners in 2022.”
Jae-Yong Ahn, CEO of SK bioscience said “This extended contract is another meaningful achievement of SK bioscience as a contract manufacturing company specialized in vaccine. It is a case that SK has proven its global-level vaccine manufacturing capability. We will continue to strive to achieve the common goal of protecting vulnerable populations through equitable supply of vaccines in this pandemic situation while establishing itself as a hub for global vaccine supply in the future.”
In August 2020, SK bioscience made both contract manufacturing and license agreements with Novavax under the capacity reservation contract with CEPI (Coalition for Epidemic Preparedness Innovation). After finishing technology transfer of the protein-based recombinant nanoparticle manufacturing and production technology from Novavax, SK bioscience also obtained the exclusive right to produce, license and supply of the vaccine candidate. The capacity reservation contract between SK bioscience and CEPI is extended until the end of 2022.
SK bioscience also proved the world-class manufacturing technology by obtaining European Good Manufacturing Practice (EU-GMP) for the COVID-19 vaccine manufacturing facility of L-House.
SK bioscience plans to continuously expand its contract manufacturing business as it has one of the world´s leading vaccine manufacturing facilities which can produce large-scale commercial production and supply worldwide. Currently, SK bioscience is investing in the facility and site expansion. The company will expand its business to be positioned as a leader of the domestic vaccine market with larger manufacturing scale and establish itself as a hub for global vaccine production.