Mabion has confirmed its ability to act quickly and effectively in the implementation of new products and, as announced, it will be able to produce an antigen for the COVID-19 vaccine in the Omicron variant, commissioned by Novavax. The process will include production, analytical testing of product samples, stability testing, sourcing of raw materials for production, quality management and supervision, and support for Novavax in meeting registration requirements. The full range of manufacturing and analytical activities related to the production of the antigen of the COVID-19 vaccine in the Omicron variant will be carried out in accordance with the GMP (Good Manufacturing Practice) standard.
“The annex regarding the possibility of ordering another product by Novavax, which is the antigen of the COVID-19 vaccine in the Omicron variant, is the implementation of the activities announced by us in September 2022. We are pleased not only with the rapid pace of Mabion’s readiness to handle orders for a new product, but also with the uninterrupted trust that our American partner has in us. (…)” – comments Adam Pietruszkiewicz, Member of the Management Board of Mabion S.A. for sales.
“The processes and activities on the part of Mabion, related to the production of the antigen for the COVID-19 vaccine in the Omicron variant on behalf of Novavax, meet the expectations and needs of many global biopharmaceutical companies. (…)” – says Sławomir Jaros, Member of the Management Board of Mabion S.A. for Operations and Science.
“According to the agreement, the number of Omicron product series ordered for production will be agreed by the parties on an ongoing basis and will fall within the Mabion production capacity guaranteed to Novavax in the form of payment for the series produced or for the readiness to manufacture the product. (…)” – adds Grzegorz Grabowicz, Member of the Management Board for Finance of Mabion S.A.
Until 2021, the Company focused on developing the portfolio of its own biological products. The agreement concluded in October 2021 with the American entity Novavax meant that Mabion successfully began to commercialize the built competences and initiated the transformation into a fully integrated GLP and GMP certified biopharmaceutical company along with CDMO services, among others, in the form of analytics and contract manufacturing. The effective performance of the USD 372 million contract with Novavax was extended to the end of 2026 as a result of the annexes concluded in September 2022, with guaranteed revenues at least until the second quarter of 2024. The annexes also extended the rules of Mabion’s remuneration with another component – on their basis, the Company will receive remuneration for manufactured series of the product or remuneration for readiness to manufacture the product (reservation of production capacity).