3rd Sep 2021 09:54
(Alliance News) - AstraZeneca PLC on Friday said it has reached an agreement with the European Commission that will end legal proceedings over a fraught Covid-19 vaccine supply deal.
As AstraZeneca's vaccine delivery disappointed at the start of the year, the EU took the company to court, arguing that the Anglo-Swedish pharmaceutical firm failed in its contractual duty. AstraZeneca's defence was that the contract only stipulated it make "best reasonable efforts" and that production was hit by unavoidable delays.
However, the two have now reached a deal which puts an end to the litigation.
As per the pact, AstraZeneca has committed to delivering 60 million doses of the vaccine by the end of the third quarter of this year, 75 million by the end of the fourth quarter and 65 million by the end of the first quarter of next year.
There will be "regular delivery schedules" for member states, the company said, and capped rebates will apply in the event of any delays.
"I'm very pleased that we have been able to reach a common understanding which allows us to move forward and work in collaboration with the European Commission to help overcome the pandemic," said Ruud Dobber, Vice President of AstraZeneca's BioPharmaceuticals Business Unit.
"We are fully committed to manufacture Vaxzevria for Europe following the release for supply of more than 140 million doses to date at no profit."
Earlier on Friday, AstraZeneca said the EU approved its severe blood disorder drug for use in children.
The coronavirus jab maker developed drug Ultomiris to treat paroxysmal nocturnal haemoglobinuria, a severe blood disorder that destroys red blood cells, leading to blood clots, organ damage and sometimes premature death.
The recent EU approval means the drug can be used to treat children with a body weight of 10 kilogrammes or above and adolescents.
The European Commission based the approval on positive interim results from AstraZeneca's Phase III clinical trial in children and adolescents with paroxysmal nocturnal haemoglobinuria.
"Ultomiris had no reported treatment-related severe adverse events, and no patients discontinued treatment during the primary evaluation period," the biopharmaceutical firm said.
Phase III results showed the drug was "effective in achieving complete C5 complement inhibition through 26 weeks for the treatment of patients up to 18 years of age" who have the ultra-rare blood disorder.
Ultomiris was recommended for child approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency back in July.
"Ultomiris provides an advancement for paediatric patients in the EU with an established safety and efficacy profile," commented King's College Hospital blood doctor Austin Kulasekararaj.
"By requiring fewer infusions each year than Soliris, Ultomiris may reduce the need for these young patients to miss school to receive treatment."
Shares in AstraZeneca were up 0.4% at 8,652.00 pence in London on Friday morning.
By Josie O'Brien; [email protected]
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