Source : 'Scrip Intelligence'
AstraZeneca PLC has said it should have Phase III data for its COVID-19 vaccine AZD1222 later in 2020 that might be sufficient for regulatory approval but stressed that the vaccine won't be a revenue driver if successful, as the group is focused on distributing it at a non-profit level.
The company updated markets on its COVID-19 response as it released another healthy set of quarterly financial results at this year’s half-way point that again highlighted its strong mid- and late-stage pipeline, which analysts said positions the British pharma for solid, deep-rooted long-term growth potential going forward. ("AZ Q2 Preview Pipeline COVID19 and MA Key Focus" "Scrip" )
AstraZeneca has taken a multi-pronged approach to helping fight the COVID-19 global pandemic over the past few months which has been driven by its monoclonal antibody (mAb) expertise.
Its programs include a collaboration with the University of Oxford for the global development and distribution of the University’s potential recombinant adenovirus vaccine, AZD1222, aimed at preventing COVID-19 infection from SARS-CoV-2. Data published data in the Lancet showed that AZD1222 was tolerated and generated a robust immune response in terms of both neutralizing antibodies and T cells. ("Solid Phase I Results For AstraZeneca COVID19 Vaccine But Two Doses Needed To Hit Efficacy Goal" "Scrip" )
AstraZeneca has also quickly moved to test new and existing medicines from multiple therapy areas to treat the infection. ("AstraZeneca Will Test More Assets Against COVID19" "Scrip" )
But its CEO, French-born Pascal Soriot, repeated the pledge that it will not profit from AZD1222 during the current pandemic.
“The challenge we’ve taken on board is to supply the world at no profit, and scale up, to allow us to vaccinate as many people as possible on a fair and equitable basis, and these are not just words – we are executing on this, and the execution is incredibly challenging. We’re getting there and making good progress … It is our total focus today,” he said when addressing AstraZeneca’s 30 July second quarter update to investors.
The company said that, after licensing coronavirus-neutralising antibodies from Vanderbilt University in the US, it has identified two mAbs that are to enter clinical development as a potential combination therapy for the prevention and treatment of COVID-19. Called AZD7442, the combo will target the SARS-CoV-2 spike protein.
It is hoped that an antibody-based treatment could neutralize the SARS-CoV-2 virus and thus, in theory, be given as a preventative option for those exposed to the virus, as well as to treat and prevent disease progression in patients already infected. It also has the potential to provide immediate effect in the patient.
AstraZeneca said it had evaluated the ability of more than 1,500 mAbs to bind to the SARS-CoV-2 virus and inhibit its capacity to infect healthy cells in a laboratory setting.
Based on those pre-clinical results, the group signed an exclusive license to six candidate antibodies currently in Vanderbilt’s portfolio that target the SARS-CoV-2 virus. In June, the company chose two monoclonal antibodies from those six to progress and will now starting clinical evaluation of the pair as a combination approach.
A possible future antibody-based treatment could potentially be used as a preventative approach for COVID-19 and could be complementary to vaccines, such as for people who may not be able to have a vaccination or to provide added protection for high-risk populations, Mene Pangalos, AstraZeneca's head of biopharmaceuticals R&D said on the Q2 analyst call.
AstraZeneca also plans to evaluate the investigational mAb combination as a potential treatment for patients with COVID-19, Pangalos added.
Asked about the chances current trials with AZD1222 could lead to a viable regulatory pathway, Pangalos replied that “the studies that we have running in the UK, Brazil, South Africa and soon to start in the US will all be two-dose studies and the data readouts from either the UK study, the Brazilian study or the South African study or a combination of those could be sufficient for regulatory approvals around the world,” he said.
CEO Soriot said it was too early to say whether AstraZeneca’s deep dive into the race to find a viable CODID-19 jab would result in the company becoming a vaccine-oriented company as well.
He noted that the company’s board of directors reviews the group’s long-term strategy every year. “Those are the kinds of discussions we're going to have over the next few months … We'll see where it takes us. But we’ll also need to have frank discussions – such as about capital allocation. It really starts with, do we have anything? Do we have an opportunity? Do we have science that we can follow? So, lots of questions. We don't have the answer. And we will look at this over the next few months,” the CEO said.
He was speaking after unveiling a robust second quarter performance in which total sales increased 11% to what? when measured at constant exchange rates, led by new oncology drugs that offset declines by mature drugs. Revenues generated by recently launched cancer drugs Tagrisso (osimertinib) and Imfinzi (durvalumab) rose 35% and 48%, respectively from a year earlier while and Lynparza (olaparib) advanced 52%. Please add sales figures for these three
Oncology medicines now represent 42% of the company's total revenue, up from 37% a year ago. But the group’s two other therapeutic pillars – BioPharmaceuticals and Respiratory & Immunology – also did well in the latest three months.
Soriot predicted that trend will continue.
“We are going through a transition period, pruning, simplifying our portfolio, reinvesting in our pipeline, and transitioning across to a different type of business,” Soriot said.
By Sten Stovall