Week's news analysis

Pfizer's goals: battling the Covid-19
and adding $15 billion sales

By The Editor - 24 september 2020

While growing anxiety is spreading worldwide with sanitary indicators on the evolution of the Covid-19 pandemic getting worse, impatience for a vaccine to arrive is growing. But the risk for the pharmaceutical industry is to bring to market vaccine candidates too quickly, under pressure of governments. The American administration intends to distribute a vaccine ahead of the presidential election in November. In order to do so, the FDA is willing to fast track a vaccine.

In the case of Pfizer, which develops a vaccine with german partner BioNTech, the company said it would never submit any vaccine for authorisation before it is safe and effective. Pfizer is at the phase III study of BNT162b2, a candidate mRNA-based vaccine, involving 30 000 participants, with a target of eventually enrolling 44 000 people.

According to CEO Albert Bourla, Pfizer should know if its experimental Covid-19 vaccine works by the end of October. He added that if approved, it could be distributed in the US by the end of the year. Mid-September, the companies indicated that "subjects in the phase III study had so far exhibited only mild-to-moderate side effects, with fatigue and headache being the two most common"

The safety of vaccines against Covid-19 has come into focus after AstraZeneca late-stage programme for AZD1222 was briefly stopped in the UK (and is still on hold in the US) before resuming a few days later. Calls for transparency have led companies to release their protocols.

Pfizer said it will have an interim analysis after just 32 people test positive (with six positive in the vaccine group and 26 positive in the placebo). That could happen around September 27. For the final analysis, of 164 cases, it will need to hit 50 % efficacy to be deemed a success by the FDA.

Confirmed Covid-19 will be defined as the presence of at least 1 of the following symptoms and a positive SARS-CoV-2 test (fever, new or increased cough, new or increased shortness of breath, chills, new or increased myalgia, new loss of taste or smell, sore throat, diarrhea or vomiting).

The secondary endpoint will study the vaccine's efficacy in cases of severe Covid-19, which will require a confirmed Covid-19 test, plus at least one of certain criteria including death, evidence of shock and respiratory failure.

Aside its race against Covid-19 the company, which got kicked off the S&P Dow Jones index in August, has tipped its pipeline to deliver more products and add around $15 billion to revenues by 2025.

Three products (JAK1 inhibitor abrocitinib, antisense therapy vupanorsen and a 20-valent pneumococcal conjugate vaccine) can generate peak annual revenues of more than $3 billion each. Pfizer also identified six other potential blockbusters, whereas five pipeline prospects could generate revenues of $500 million to $1 billion. About the same period (in 2026 and 2027), the Big Pharma will face another "patent cliff" with patents on Prevnar 13, Eliquis and Xtandi set to expire. In 2019, these products generated sales of more than $6 billion.

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