Mabion received an order from Novavax, under the existing framework contract regarding the COVID-19 vaccine, for the implementation of the raw material order – Mabion said in a release.
The order was placed in connection with the ongoing negotiations on a potential production agreement under which the company could produce for Novavax the active substance of a vaccine candidate for COVID-19 with the working name NVX-CoV2373 on a commercial scale.
“In order to improve the future production process in the company, Novavax and the company signed SOW # 2 (Statement of Work # 2) under the existing framework agreement, which allows the company to order key raw materials for production in advance under an agreed and financed by Novavax of the budget. SOW # 2 concerns the procurement of raw material volumes allowing for the future conduct of the commercial production of the active substance involving the full production capacity of Mabion by the end of the first half of 2022 (according to the company’s estimates) “- Mabion said in a statement
As stated, the company will receive full prepayment from Novavax for the execution of the raw material order.
“The contracting of raw materials for production at the present stage of cooperation, i.e. in advance, will allow for faster commencement of commercial production services in the event of concluding a production contract. After signing the production contract, the intention of the parties will be to regularly submit similar orders for raw materials (according to separately agreed budgets and schedules) in subsequent periods “- it was written.
Mabion also informed that the conclusion of the production contract still requires the parties to clarify the arrangements regarding technical, financial, quality and schedule issues, and depends primarily on the successful completion of the first technical order. The company points out that the order does not determine whether the production contract will be finally concluded.
“In the event of failure to conclude a production contract, the ordered raw materials for production will be transferred to Novavax or settled with Novavax in cash” – it was written.
“The production line is almost complete.” The company’s priority is to find a strategic investor“
As for the strategic investor, the priority is to ensure a stable long-term source of financing for the further development of Mabion – this is the main goal “- said Adam Pietruszkiewicz, board member.
As he informed, the process of finding an investor is at an early stage.
Currently, Mabion is implementing the first stage of the contract with Novavax for the production of a vaccine component against COVID-19. carrying out the process on a laboratory scale, and a second stage – commercial production – is agreed.
“We are currently working. They are proceeding as planned. We have already obtained the vaccine antigen in the laboratories” – said Sławomir Jaros, board member.
He informed that the production line owned by the company is sufficient for the production of the vaccine antigen and is almost fully ready to produce a vaccine – Mabion waits only for single devices for commercial production.
“The devices I mentioned do not limit our ability to scale up the process in the first stage of cooperation and test series execution” – added the board member.
Pietruszkiewicz said that Novavax would like to use the full production scale offered by Mabion.
He added that despite the fact that Mabion is still at the first stage of the contract, it wants to continue working with Novavax, which is to be confirmed by Wednesday’s announcement about the order.
At the beginning of March, Mabion concluded a framework agreement with Novavax for technology transfer and technical tests of the production of the COVID-19 vaccine on a commercial scale. The company has also concluded an agreement with the Polish Development Fund regarding PFR investments up to the amount of PLN 40 million for the purpose of increasing the company’s production capacity, in particular for the purposes of potential wider cooperation with Novavax.
Pietruszkiewicz said that the details of the contract with Novavax are confidential, but when it comes to the ordered raw materials, they should be sufficient for serial production more or less until the middle of next year, so – in the opinion of the management board – this is a significant scale.
“It is certainly a big step in our cooperation with Novavaks. Such an order confirms that it sees us as a long-term partner” – added the board member.
According to Pietruszkiewicz, in addition to the process of acquiring a strategic investor, the company is working on a partnering contract for Mabion CD20 for Europe and the United States.
When asked where the registration of Mabion CD20 is expected in the first place, Jaros replied that the company assumed that it would be Europe.
As the management board informed, in the field of Mabion CD20, the company has completed the full-scale process validation, clarifies the regulatory strategy, is conducting a bridge clinical trial and is waiting for regulatory approval to start the second phase of the clinical trial in which it will treat patients. (PAP Biznes)
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