Covid-19 roundup: AstraZeneca launches new virus R&D division; US buys more of Merck's antiviral pill
AstraZeneca is launching a new division to encompass its vaccine and antibodies businesses.
The subunit will focus on its Covid-19 vaccine and long-acting antibody combination, a company spokesperson told Endpoints News in an email, as AstraZeneca looks to move past its early pandemic stumbles. Iskra Reić, who currently serves as executive VP for Europe and Canada, will lead the division.
“In order to optimise the management of our existing portfolio of vaccines and antibodies for viral respiratory infections, we are creating a dedicated Vaccines and Immune Therapies Unit that brings together R&D, manufacturing, commercial and medical teams,” the spokesperson wrote. “The team will be dedicated to our COVID-19 vaccine, our long-acting antibody combination and our developmental vaccine addressing multiple variants of concern, as well as to our existing portfolio for respiratory viral disease.”
The Financial Times first reported the news Tuesday morning. There likely won’t be any significant investment to go along with the reorganization, FT reported, with another AstraZeneca official claiming CEO Pascal Soriot will be able to hone in more on other businesses like oncology.
AstraZeneca started off the Covid-19 vaccine race as one of the industry’s leaders, partnering with Oxford University on a shot based on adenovirus technology. The company started its large-scale Phase III around the same time as Pfizer/BioNTech and Moderna, enrolling thousands of participants in summer 2020.
But around Labor Day of that year, AstraZeneca halted that Phase III study globally after a participant developed symptoms thought to resemble a neurological condition. The trial soon resumed outside the US, but didn’t get the FDA go-ahead for about another month after the initial pause.
Then, in March 2021, AstraZeneca drew fire from scientists after revealing interim results from the Phase III, with NIAID director Anthony Fauci criticizing the company for posting “outdated information.” At the time, the latest data reported by AstraZeneca included results only through Feb. 17, 2021, more than a month before sending out its press release.
When the company scrambled to announce the newest data, though, hours later, the efficacy was virtually the same.
Around the same time, several European countries — where the shot had already been authorized — were halting use of the vaccine over fears of blood clots. Some countries also threatened to sue AstraZeneca over vaccine shipment delays.
The vaccine has nevertheless served as the primary Covid-19 shot for large swaths of the globe, including for many places unable to acquire mRNA shots. AstraZeneca and its partner the Serum Serum have shipped over 1.3 billion doses.
It’s been a long, bumpy road for AstraZeneca’s Covid-19 R&D, but Tuesday’s report is ostensibly an attempt to move past the missteps. AstraZeneca’s vaccine is still not authorized in the US, however, and it’s unclear if the new division will also take on the company’s attempts to persuade the FDA. — Max Gelman
US opts into buying more Merck antiviral pills
As the race for Covid-19 antiviral pill treatments heats up between Merck and Pfizer, the former is trying to ensure it can capture as much of the market as possible before a potential authorization.
Merck announced Tuesday that the US government had purchased another 1.4 million courses of molnupiravir, the investigational pill the company said can cut hospitalization and death from Covid-19 by 50%. In exchange for the pills, Merck will net roughly $1 billion should the EUA come through in the next few weeks.
Molnupiravir is slated for an adcomm on Nov. 30 after Merck and its partner Ridgeback Biotherapeutics submitted their pitch last month.
“In light of the continued impact of the pandemic on hundreds of thousands of people every day, all of us at Merck are moving with urgency and rigor to bring molnupiravir, with its compelling data showing a significant reduction in death and hospitalizations, to patients as quickly as we can,” Merck president of human health Frank Clyburn said in a statement.
With Tuesday’s new options exercised, the US has now purchased more than 3 million courses of the Covid-19 antiviral, to be acquired from authorization through early 2022, Merck said. The contracts have earned Merck a cool $2.2 billion so far, and there are two million courses available through further options.
Merck and Ridgeback first announced their pill could reduce the chance that a newly diagnosed Covid-19 patient would be hospitalized or die at the beginning of October, claiming a potential pandemic breakthrough. Should it be authorized, the pill would give doctors and hospitals a new tool — on top of monoclonal antibodies — to keep at-risk individuals out of intensive care.
Though the antibody treatments have proved potent, they require IV infusions or injections and can prove relatively inaccessible in areas with limited resources.
But soon after Merck’s revelation, Pfizer sauntered in with a pill it claims can reduce hospitalizations and deaths in new Covid-19 patients by 89%. Pfizer, which announced the news last Friday, added that it hasn’t agreed to any US deal just yet, though it has signed advance agreements with several other countries.
All eyes will likely be on the upcoming arms race for a potentially multibillion dollar market, and it’s one where Merck may face some added pressure. Pfizer’s Covid-19 vaccine was the first approved and has made the company billions, while Merck — the world’s leading vaccine maker prior to the pandemic — struck out in its early vaccine attempts. — Max Gelman
Inovio gets FDA permission to start PhIII vax trial
Small biotech Inovio has been facing several roadblocks in the US with its Covid-19 vaccine candidate.
The company’s planned Phase II/III trial got put on hold last September. After the FDA signed off on the Phase II segment of the trial more than a month later, it left the Phase III portion in limbo. Then, the DoD scuttled its funding for the PhIII portion earlier this year.
Now, the biotech finally gets to start the next phase of the trial in the US.
Inovio said via a press release this morning that the FDA granted authorization to the biotech to start the Phase III segment of a clinical trial for the investigational INO-4800 in the US, by lifting the partial clinical hold put on the study nearly 14 months ago.
This comes three months after Brazil OK’d the Phase III segment of the trial.
“Today’s U.S. announcement builds on our intensive global efforts in India, Brazil, Philippines, Mexico, Colombia, and Thailand where we have received authorizations to date,” said CEO Joseph Kim in a statement.
Inovio is partnering with Advaccine Biopharmaceuticals, based in Suzhou, China, to conduct the Phase III segment of the trial in multiple countries in the Americas, Asia, and Africa, which will evaluate the efficacy of the vaccine in two doses, given one month apart. — Paul Schloesser
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