CSL starts work on the next epidemic

Australia’s biggest health company CSL is working with the US government to protect the world’s biggest economy from another health shock.

Dr Andrew Nash is the Chief Scientific Officer for CSL, working on a potential COVID-19 vaccine. Photograph by Paul Jeffers The Australian 02 Oct 2020

Australia’s biggest health company CSL is preparing for another pandemic, working on a project with the US government to protect the world’s biggest economy from another health shock.

The preparation comes as the world is yet to contain and develop an effective treatment for COVID-19, with health companies and governments working on developing more than 190 vac­cines, with the first doses not expected until early next year — and that’s only if crucial phase three trials are successful.

But CSL executive vice president, head of research and development and chief medical officer Bill Mezzanotte said preparation was vital in defending the world against future health crises.

The project involves the manufacture and stockpiling of AUDENZ, the first adjuvanted, cell-based influenza vaccine designed to protect against A(H5N1), commonly known as bird flu.

CSL’s influenza vaccine business Seqirus — pronounced ‘‘secure us’’ — developed AUDENZ, which the US Food and Drug Administration (FDA) has approved and the US government will begin stockpiling to protect first responders in the event of a pandemic.

The vaccine was developed and will be manufactured at Seqirus’s factory in Holly Springs, North Carolina.

“Pandemic preparedness is part of business in Seqirus, and I’d like to say ‘you don’t make a lot of money in responding to a pandemic, you do it in preparing for a pandemic’,” Mr Mezzanotte told The Australian following CSL’s annual R&D day.

“What we are doing is trying to be prepared and in this case working with the US government, because it is at Holly Springs where it is being done right now. We have taken that strain (of bird flu) and preparing a vaccine for that strain, with the use of our adjuvant, so we have lots of doses available in the future when and if another pandemic in the bird flu would come.

“It’s our hope that in the future we will be able to do that in other places in the world but it depends on manufacturing capability.”

The Hope Springs facility was built and supported through a multi-year public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA director Rick Bright said.

“With this licensure — the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic.”

The bird flu vaccine came as COVID-19 had hit more than 70 per cent of CSL’s $1bn research and development portfolio, leading to trials being halted as the company’s research partners had become overwhelmed, Mr Mezzanotte said.

“We did have a few disappointments this year. We elected to stop the CSL 324, our anti-G CSFR antibody program for acute lung injury, due to COVID-19.

“While we were very excited about this, this was stopped due to a high level of competition at clinical trial sites for studying new modalities for COVID-19, and our own competing anti-COVID-19 programs, and the important fact that we still require proper dose exploration of this program to avoid any untoward results.”

But Mr Mezzanotte said COVID-19 had delayed CSL’s R&D program by about four months but it had since been able to make up about half of that time.

“While some of our programs have had lingering slowdowns, most have rebounded nicely and are recruiting again. This has been due to the remarkable focus in communication of our teams, with staff all over the world, and excellent planning for re-initiation when regions and hospitals allowed.”

Australia’s biggest health company CSL is preparing for another pandemic

CSL’s spend on R&D rose to $US922m last financial year from $US832m, equating to about 10-11 per cent of the company’s annual revenue.

Mr Mezzanotte said the company wasn’t expecting a significant increase in R&D spending this year, citing the company’s COVID-19 program as well as maintaining financial discipline.

“I don’t think it will rise substantially this year, some of it because of cumulative cost, some of it to be conservative and some of it because we’ve put so much effort into COVID — and those expenditures, in how we track it and the relations, are somewhat different.

“For instance the (COVID-19) hyper-immune trial is done through the NIH (US National Institutes of Health) so we are putting a lot of effort there … but the clinical trial is actually being sponsored and run by the NIH so we don’t accumulate that cost, so that’s an example of what’s different.”

CSL focuses its R&D on six therapeutic areas, including immunology, hematology, respiratory, cardiovascular and metabolic, transplant and influenza vaccines.

It has been developing a COVID-19 vaccine with the University of Queensland and a hyper-immune therapy to treat patients with complications.