First Shipment Of PAXLOVID, Pfizer’s Novel COVID-19 Oral Treatment Arrives In New Zealand

• PAXLOVIDTM (nirmatrelvir [PF-07321332] is the first oral treatment of its kind; it includes nirmatrelvir, a 3CL (or main) protease inhibitor specifically designed to combat SARS-CoV-2.

tablets and ritonavir tablets)

• Medsafe gave provisional consent for PAXLOVID for supply to New Zealand in early March 2022.

• Data demonstrated an 89% and 88% reduction in risk of COVID-19-related hospitalisation or death from any cause in adults treated with PAXLOVID within three and five days of symptom onset, respectively, compared to placebo.

AUCKLAND, NEW ZEALAND, 31 March 2022 – Pfizer announced today that New Zealand has received its first delivery of PAXLOVIDTM [PF-07321332]

This follows Medsafe’s provisional consent for the supply and use of PAXLOVID PAXLOVID has provisional consent for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of

age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.

PAXLOVID is an oral treatment and should be taken within the first five days of symptomatic infection. Data demonstrated an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause in adults treated with PAXLOVID compared to placebo in those treated within three days of symptom onset, with no deaths in the treatment group.

PAXLOVID is the first oral treatment of its kind; it includes nirmatrelvir, a 3CL protease (also known as Main protease or Mpro) inhibitor that was specifically developed in Pfizer's laboratories to combat SARS-CoV-2.

“This milestone in New Zealand is an important moment in our continued fight against COVID-
19, paving the way for use of PAXLOVID as cases continue to rise and we address the threat of the current variant of concern, Omicron,” said Anne Harris, Pfizer New Zealand Managing Director.

“Whilst vaccination remains the most effective way to help prevent COVID-19, this oral treatment provides us with another important line of defence - to reduce hospitalisations and save lives. PAXLOVID has the potential to transform COVID-19 treatment and help lessen the devastating impact of the virus that has now claimed nearly six million lives globally”, Ms Harris said.

providing an important oral treatment for adults with COVID-19.

(nirmatrelvir

tablets and ritonavir tablets),

in New Zealand in early March 2022.

In December 2021, Pfizer announced an agreement with Pharmac to supply 60,000 treatment courses of PAXLOVID to New Zealand over 2022.

Medsafe based its decision on positive results from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis, which enrolled non-hospitalised adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data showed that PAXLOVID reduced the risk of hospitalisation or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, with no deaths observed in the treatment group. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. These data were recently published in the New England Journal of Medicine. Additional Phase 2/3 clinical trials are ongoing in adults at standard risk (i.e., low risk of hospitalisation or death) of progressing to severe illness, and in those who have been exposed to the virus through household contacts.

(nirmatrelvir tablets and ritonavir tablets)

PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorisation, at first awareness of an exposure – potentially helping patients

About PAXLOVIDTM

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avoid severe illness (which can lead to hospitalisation and death) or avoid disease development following contact with a household member who contracts COVID-19. Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against earlier and current variants of concern (i.e., Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron).

PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Our Commitment to Equitable Access

Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price. During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorisation or approval, based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries. Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options. As a result of these efforts, Pfizer has raised its production projections, with the ability to produce up to 120 million courses of treatment by the end of 2022, pending global demand.

The company has initiated bilateral outreach to more than 100 countries around the world and has entered into agreements with multiple countries. Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorisation or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

About the EPIC Development Program

The EPIC (Evaluation of Protease Inhibition for COVID-19) Phase 2/3 development program for PAXLOVID consists of four clinical trials spanning a broad spectrum of participants, including adults who have been exposed to the virus through household contacts, adults at both standard risk and high risk of progressing to severe illness, and children under the age of 18 at risk of progressing to severe disease.

In July 2021, Pfizer initiated the first of these trials, known as EPIC-HR (Evaluation
of Protease Inhibition for COVID-19 in High-Risk Patients), a randomised, double-blind study of non- hospitalised adults with COVID-19, who are at high risk of progressing to severe illness. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. FDA, Pfizer ceased further enrollment into the study in early November 2021 due to the overwhelming efficacy demonstrated in these results. Findings from the EPIC-HR final analysis were published online in The New England Journal of Medicine on February 16, 2022.

In August 2021, Pfizer began the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study to evaluate efficacy and safety in adults with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., low risk of hospitalisation or death). Interim data from this study have been reported. Pfizer is currently expanding the population of the ongoing EPIC- SR study by approximately 800 participants and expects to share results later this year.

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In September 2021, Pfizer initiated the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition
for COVID-19 in Post-Exposure Prophylaxis) study to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member. This trial is also ongoing, and Pfizer expects to share results later this year.

For more information on the EPIC Phase 2/3 clinical trials for PAXLOVID, visit clinicaltrials.gov.

About the EPIC-HR Final Results

In the final analysis of the primary endpoint from all patients enrolled in EPIC-HR, an 89% reduction in COVID-19-related hospitalisation or death from any cause compared to placebo in patients treated within three days of symptom onset was observed, consistent with the interim analysis. In addition, a consistent safety profile was observed.

0.7% of patients who received PAXLOVID were hospitalised through Day 28 following randomisation (5/697 hospitalised with no deaths), compared to 6.5% of patients who received placebo and were hospitalised or died (44/682 hospitalised with 9 subsequent deaths). The statistical significance of these results was high (p<0.0001). In a secondary endpoint, PAXLOVID reduced the risk of hospitalisation or death from any cause by 88% compared to placebo in patients treated within five days of symptom onset; 0.8% of patients who received PAXLOVID were hospitalised or died through Day 28 following randomisation (8/1039 hospitalised with no deaths), compared to 6.3% of patients who received placebo (66/1046 hospitalised with 12 subsequent deaths), with high statistical significance (p<0.0001). In the overall study population through Day 34, no deaths were reported in patients who received PAXLOVID as compared to 13 deaths in patients who received placebo.

In the EPIC-HR trial, in a secondary endpoint, SARS-CoV-2 viral load at baseline and Day 5 have been evaluated for 1574 patients. After accounting for baseline viral load, geographic region, and serology status, PAXLOVID reduced viral load by approximately 10-fold relative to placebo when treatment was initiated within three days of symptom onset, indicating robust activity against SARS- CoV-2 and representing the strongest viral load reduction reported to date for an oral COVID-19 agent.

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Fewer serious adverse events (1.6% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.2%) were observed in patients dosed with PAXLOVID, compared to placebo, respectively.

All other secondary endpoints for this study, which are available on clinicaltrials.gov (NCT04960202) and EudraCT (2021-002895-38), were not yet available for this review.

About Pfizer: Breakthroughs That Change Patients’ LivesTM

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

www.pfizer.co.nz

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