Ireland is set to play a key role in delivering Pfizer's new $1 billion Covid-19 tablet, with the company's Ringaskiddy plant in Cork manufacturing the entire global supply of the drug.
The US pharma giant has stopped a trial of its experimental antiviral pill to tackle the virus early after the drug was shown to cut by 89 per cent the chances of hospitalisation or death for adults at risk of developing severe disease.
It said on Friday that it now plans to submit interim trial results for the pill, which is given in combination with an older antiviral called ritonavir, to the US Food and Drug Administration.
That filing is expected to be submitted before Thanksgiving, November 25th, Pfizer chief executive Albert Bourla said. A European filing will follow, possibly before the end of the year. Both US and European authorities have had the Pfizer tablet under rolling review, which could shorten the process of securing initial conditional approval.
Industry sources said the tablets might be available as early as the new year if the whole process goes smoothly.
Pfizer's plant in Ringaskiddy will be pivotal to the manufacture of the new drug which will then go to other plants in Europe for finishing as a tablet, assuming it wins regulatory approval. The company's Newbridge, Co Kildare plant will be one of those used as a finishing plant.
The Ringaskiddy plant has already begun to make the drug so that supplies will be available if and when approval is granted.
Pfizer has entered into advance purchase agreements with multiple countries and is in negotiations with several others. However, the European Union has yet to engage on a supply arrangement.
The EU only moves to agree central purchasing of drugs if sufficient member states press the case. The lack of such an approach means EU states may look to agree terms individually. It is not clear whether Ireland, which is currently experiencing a surge in Covid-19 cases, has sought an EU-wide deal. Smaller states tend to fare less well in individual negotiations.
With the virus still circulating widely and current therapeutic options requiring access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed, Cantor Fitzgerald analyst, Louise Chen, said.
The planned analysis of 1,219 patients in Pfizer’s study looked at hospitalisations or deaths among people diagnosed with mild to moderate Covid-19 with at least one risk factor for developing severe disease, such as obesity or older age.
It found that 0.8 per cent of those given Pfizer’s drug within three days of symptom onset were hospitalised and none had died by 28 days after treatment. That compared with a hospitalization rate of 7 per cent for placebo patients. There were also seven deaths in the placebo group. Rates were similar for patients treated within five days of symptoms.
Mr Bourla said the drug could eliminate nine out of 10 hospitalisations.– Additional reporting: Reuters