Policy & Regulation
Pfizer Updates on Pipeline Advances for COVID-19 Programmes
15 September 2020 - - As part of a two-day virtual Investor Day, US-based biopharmaceutical company Pfizer Inc. (NYSE: PFE) has provided an extensive overview of pipeline advances and shared updates on the company's efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE, the company said.

The pipeline updates contribute to the company's expectation of at least a 6% revenue CAGR over the next five years, as well as delivery of longer-term topline growth beyond that period.

Pfizer's goal of delivering up to 25 breakthroughs to patients by the year 2025 has 38 such opportunities to draw from as of TODAY, including the company's 20-valent pneumococcal conjugate vaccine candidate (20vPnC).

On a non-risk adjusted basis, these opportunities collectively represent more than USD 15bn (excluding 20vPnC) in potential incremental revenue for Pfizer from 2020 to 2025, as well as aggregate peak annual sales potential of USD 35bn to USD 40bn (including 20vPnC).

If successful, the company's COVID-19 programmes would be incremental to these estimates, Pfizer said.

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises.

Pfizer and BioNTech shared several updates from their BNT162 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease, including:

Additional information on the BNT162b2 vaccine candidate, including new stability data that supports the storage of vials at refrigerated (2-8 °C) conditions for up to 5 days at the administration point of use locations.

Phase 1 immunogenicity data for the BNT162b2 candidate at two weeks post second dose (35 days) provide additional data that neutralizing geometric mean titers remain higher than that of a panel of human SARS-CoV-2 convalescent sera, building on data previously shared by the companies.

They also includes limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2.

The company submitted of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allows for the enrollment of new populations.
Enrollment in the trial has been proceeding as planned with current enrollment at more than 29,000. Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814.

Of note, the Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

The start of this clinical study is supported by preclinical data conducted in collaboration with leading academic collaborators and demonstrates the anti-viral activity of this potential first-in-class SARS-CoV-2 therapeutic designed specifically to address COVID-19.

Two manuscripts describing the preliminary preclinical data are currently available on preprint servers at Link and Link; both manuscripts are concurrently undergoing scientific peer review for potential publication.

Pfizer shared significant research advances across its various therapeutic areas including candidates with blockbuster potential expected to launch by 2025.

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.