It was the kind of day that could give any AstraZeneca investor whiplash.
First, on Friday, Nancy Pelosi, Speaker of the U.S. House of Representatives, and one of America’s most powerful Democrats, said that the U.S. should not grant approval for the COVID-19 vaccine being developed by the British-Swedish pharmaceutical giant based solely on clinical trial data from the U.K.
In the process, she faulted the U.K. drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), for being less stringent than the U.S. regulator, the Food and Drug Administration.
“My concern is that the UK’s system for that kind of judgment is not on a par with ours in the United States,” she said, according to The Financial Times.
Oof. But no sooner had AstraZeneca absorbed that low blow from the House Speaker than it got a boost of good news from Washington.
Also on Friday, the company announced that a synthetic antibody (also known as a monoclonal antibody) that it has been developing as a treatment for those already ill with Covid-19, but which it believes will also confer six to twelve months of immunity to the virus, was moving to Phase III clinical trials in the U.S. What’s more, the U.S. government is providing the company with $486 million to help develop the medicine.
Synthetic antibodies are made in labs from modified cell lines genetically engineered to produce a protein that will, much like natural antibodies, bind to a receptor on the surface of a pathogen, preventing it from infecting other cells and replicating.
Pascal Soriot, AstraZeneca’s chief executive officer, said in a statement that the medicine had “the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections.”
The company has agreed to supply the U.S. with up to 100,000 doses of the long-acting antibody (or LAAB) treatment, known as AZD7442, by the end of the year, while a separate agreement gives the U.S. the right to acquire up to one million additional doses in 2021.
And then, came yet another piece of good news: the Australian drug regulator, the Therapeutic Goods Administration (TGA), took the first step toward approving the company’s COVID-19 vaccine. The agency granted the vaccine what’s known as “provisional determination” based on the results of the vaccine’s earlier human safety trials. This designation will allow AstraZeneca to apply to have the vaccine approved for use in Australia, potentially even before all the late stage human trials are concluded.
One of the frontrunners
AstraZeneca is among the frontrunners in the race to develop a coronavirus vaccine. Late stage clinical trials of the vaccine, which it is jointly developing with the University of Oxford, are underway in the U.K. and several other countries around the world.
Those trials were paused for one week last month, however, to investigate whether a serious medical condition one volunteer in the U.K. study developed was related to the vaccine. An independent review board and the British drug regulator concluded the volunteer’s condition was unlikely to have been caused by the inoculation and trials were allowed to resume.
But trials of the vaccine in the U.S. remain suspended because the FDA has asked for more data about safety issues that have arisen in previous trials for vaccines that use the same underlying technology, pioneered by Oxford.
Pelosi said she was concerned that the U.K. MHRA might approve the AstraZeneca vaccine for use and that U.S. President Donald Trump might use the U.K.’s decision as a justification to grant emergency use authorization for the vaccine in the U.S.
The Trump Administration has been desperate to deliver a vaccine in the next several weeks in order to boost Trump’s reelection chances which have been hurt by perceptions that he has mishandled the pandemic. Democrats fear political motivations will lead him to grant approval to a vaccine that might not be safe and they worry that even the perceptions that this might be happening will erode public confidence in any vaccine that is approved.
The U.K. government and the British press, however, did not take kindly to Pelosi’s remarks. “Nancy Pelosi attacks Oxford scientists,” blared The Express. BBC political commentator Andrew Neil said the U.S. politician has “no idea what she is talking about.”
The U.K. Department for Health and Social Care said the UK had “some of the most robust standards for approving new treatments and vaccines in the world,” adding that “any vaccine must go [through] clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency, which has vast experience in ensuring the delivery of a safe and effective vaccines.”
So, on the whole, it looks like two steps forward and one step back for AstraZeneca’s Covid-19-related efforts. And lately it’s been those efforts that have been moving AstraZeneca’s shares. But investors might be wiser to pay attention to what’s happening in the rest of the company’s business—where AstraZeneca’s momentum has been less halting.
Last week, equity research firm Liberum raised its price target for AstraZeneca’s shares to £97.70 (currently they are at £84.60), largely on the strength of a $6 billion deal the company signed in August with Japan’s Daiichi Sankyo to co-develop an antibody and drug combination therapy for certain cancers. The second multi-billion dollar deal AstraZeneca has struck with Daiichi, Liberum said it believed the new drug therapy “will become a blockbuster drug” with peak sales of at least $2.6 billion per year.
