The CSL Limited (ASX: CSL) share price is pushing higher today after the release of an announcement.
At the time of writing the biotherapeutics company’s shares are up over 1% to $295.62.
What did CSL announce?
This morning CSL announced that its Seqirus vaccines business has signed a final agreement with the Commonwealth of Australia.
This agreement is for the supply of 51 million doses of the University of Queensland-CSL COVID-19 vaccine candidate (V451), should clinical trials be successful.
According to the release, it also includes an up-front financial commitment from the Government to support the clinical and technical development activities that CSL will need to assume in order to progress V451.
Furthermore, if clinical trials are successful, the agreement secures access to onshore production and supply of the vaccine for Australia.
What is V451?
The company advised that it has been working hard to respond to the current COVID-19 pandemic and has invested significant resources in the rapid development and large-scale manufacture of V451, along with a number of other therapeutic programs.
Pleasingly, the large-scale Phase 2b/3 clinical study for V451 is almost ready. Management notes that it will be a randomised, observer-blinded, placebo-controlled study across numerous countries and upwards of 100 sites.
The study will evaluate efficacy, immunogenicity, and safety in adults aged 18 years and above.
Subject to progress in the current Phase 1 study, the first subject for the Phase 2b/3 would be enrolled in December 2020, with the goal of completing recruitment by March 2021.
Management commented: “We are committed to demonstrating the vaccine is safe and effective prior to availability in the market. Discussions have already commenced with the Australian Therapeutic Goods Administration (TGA) to ensure this goal is met, while also making the vaccine available to the Australian population in the shortest possible time.”
In addition, CSL advised that it is working to engage partner organisations to assist with production of further doses with the goal of providing broader access to the vaccine, should clinical trials be successful.
This is on top of the agreement the company has signed with the Government to manufacture the Oxford University/AstraZeneca vaccine candidate (AZD1222) if successful.
Though, given the risk, effort, cost and uncertainty associated with the development of these novel vaccines, management warned that it is too early to calculate the financial impact of these activities.