(Alliance News) - AstraZeneca PLC will part with GBP15 million upfront as part of an 18-month supply agreement with Oxford Biomedica, the cell gene therapy firm said on Tuesday.
AstraZeneca shares were 1.0% higher at 8,424.00 pence each in London on Tuesday morning. Oxford Biomedica shares climbed 2.6% to 866.20p.
The deal is part of a three-year master supply and development for Astra's Covid-19 vaccine candidate AZD1222, which the drugmaker is developing alongside Oxford University.
The deal covers the large-scale commercial manufacture of AZD1222, Oxford Biomedica said, and the two may extend the supply period by a further 18 months into 2022 and 2023 should they agree to.
Under the terms of the deal, AstraZeneca will pay Oxford Biomedica GBP15 million upfront as a capacity reservation fee. Subject to the scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of GBP35 million plus costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.
Oxford Biomedica will reserve capacity for AstraZeneca in up to three manufacturing suites in its commercial manufacturing centre, Oxbox, for an initial 18-month period.
In the US, the development of the vaccine has moved to its later stages, Astra on Monday said, with trial centres recruiting up to 30,000 adults from a variety of ethnic groups. Recruitment will also include those with underlying medical conditions which leave them more exposed to the SARS-CoV-2 virus.
In July, AstraZeneca posted encouraging interim results from a trial of the vaccine, being developed alongside Oxford University.
The much-anticipated findings showed that a single dose of AZD1222 resulted in a four-fold increase in antibodies fighting SARS-CoV-2, the virus strain which causes Covid-19.
Also on Monday, Astra outlined its "commitment to the highest safety standards and to broad and equitable access around the world" for its Covid-19 vaccine.
"At the heart of AstraZeneca's core values is to 'follow the science' and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance. The company's submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world," the company said.
The statement came after reports on Sunday raised the possibility that a future vaccine against the coronavirus might be given emergency approval in the US before the end of trials designed to ensure its safety and effectiveness.
A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn - the head of the US Food & Drug Administration - told the Financial Times.
"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination."
But Hahn insisted he was not acting under pressure from US President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.
Elsewhere, Astra secured EU approval for its Imfinzi small cell lung cancer treatment.
"The approval by the European Commission was based on positive results from the Phase III CASPIAN trial showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit for the 1st-line treatment of patients with extensive stage-small cell lung cancer," Astra said.
By Eric Cunha; ericcunha@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
Astrazeneca (AZN)
Oxford Biomedica (OXB)
