Pfizer to provide New Zealand its investigational oral antiviral for COVID-19

Pharma News: Pfizer New Zealand announced an agreement with the New Zealand Government to supply 60,000 treatment courses of its investigational COVID-19 oral antiviral candidate, PF-07321332; ritonavir, subject to regulatory approval from Medsafe.

If approved or authorised, PF-07321332; ritonavir would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. A rolling regulatory submission has commenced in New Zealand for provisional approval by  Medsafe.

Under the terms of the agreement, the New Zealand Government will acquire an initial quantity of 60,000 treatment courses, subject to approval by Medsafe, to be delivered to New Zealand over the course of 2022. Pricing for PF-07321332; ritonavir, is based on the principles of advance commitment, volume, equity and affordability.

“We are honoured to work with the New Zealand Government toward achieving our shared goal of addressing this public health crisis,” said Anne Harris, Pfizer New Zealand Managing Director. “If approved , oral protease inhibitor antiviral therapies may help to reduce the severity or onset of illness in adults who contract, or have been exposed to, COVID-19. An oral treatment option may thus be an important potential tool to help address the ongoing global impact of the COVID-19 pandemic,” Ms. Harris said.

“We were very encouraged by the recent results of our Phase 2/3 interim analysis, which showed overwhelming efficacy of PF-07321332; ritonavir in reducing the risk of hospitalisation compared to placebo among high-risk patients adults treated within three days of symptom onset by almost 90% and with no deaths, with similar results seen with those treated within five days, and are pleased that the New Zealand Government recognises this potential.

“It is promising to see a growing understanding of the valuable role that oral investigational therapies may play in combatting COVID-19, and we look forward to continuing our discussions with the New Zealand Government to help ensure broad access for New Zealanders”, Ms Harris said.

Pfizer is also working towards equitable access to ritonavir globally. The company will continue to invest up to approximately US$1 billion to support the manufacturing and distribution of this investigational treatment candidate, including exploring potential contract manufacturing options. It has entered into agreements with several countries and has initiated bilateral outreach to approximately 100 countries around the world. Additionally, Pfizer has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending regulatory authorisation or approval, in 95 low-and middle-income countries that account for approximately 53% of the world’s population.