6 May 2021

CSL Closes Commercialisation and License Agreement for Novel Late-Stage Gene Therapy Candidate from uniQure

CSL Limited (ASX:CSL; USOTC:CSLLY) announces the closing of CSL’s global commercialisation and license agreement with uniQure (NASDAQ: QURE) for etranacogene dezaparvovec (AMT-061), a novel gene therapy for the treatment of haemophilia B. Etranacogene dezaparvovec is currently in Phase 3 clinical trials and has been shown to result in near-normal levels of Factor IX (FIX) – the blood clotting protein lacking in people with haemophilia B.

The global licensing agreement was announced on 24 June 2020 and the closing follows the completion of antitrust reviews of the transaction in the US, the UK and Australia. Under the terms of the agreement, uniQure will receive an upfront cash payment of US$450 million by 13 May, 2021, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialised.uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply while CSL Behring will be responsible for regulatory submissions and commercialisation.

“We are continuing to build on our legacy of delivering lifesaving innovations in haematology with today’s news. This agreement enables us to take forward a gene therapy that, if approved, has the potential to transform the lives of haemophilia B patients,” said CSL CEO and Managing Director Paul Perreault. “Etranacogene dezaparvovec has the potential to be the first-ever gene therapy approved for haemophilia B and help CSL Behring deliver on our ongoing commitment to improving the lives of those living with haemophilia B.”

The acquisition complements both CSL Behring’s cell and gene therapy scientific platform and its haematology product portfolio, which include other treatments for haemophilia B as well as therapies for treating haemophilia A, von Willebrand disease, thrombosis, and other life-threatening conditions.

About Etranacogene Dezaparvovec (AMT-061)

Etranacogene dezaparvovec (also known as AMT-061) uses a specific type of AAV, called AAV5, as its delivery vehicle. The AAV5 vector carries the patent-protected Padua gene variant of Factor IX (FIX-Padua), which generates FIX proteins that work 8x harder than normal. Preclinical and clinical data show that AAV5-based gene therapies may be clinically effective in the 95 percent of haemophilia B patients with pre-existing antibodies to AAV vectors, thereby potentially increasing patient eligibility for treatment compared to other AAV gene therapy product candidates.

TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia

21 March 2021

Earlier today, the Therapeutic Goods Administration approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia. This follows on from the 16 February 2021 approval by TGA of the overseas-manufactured AstraZeneca vaccine.

Manufacture of biological medicines such as vaccines is a highly-specialised process and the establishment of Australian manufacture of COVID-19 Vaccine AstraZeneca by CSL - Seqirus has involved extensive work by both industry and the TGA over the last six months. Today's approval is a critical and very exciting milestone in Australia's response to the COVID-19 pandemic.

Specific approval of Australian manufacturing by TGA was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as overseas-manufactured vaccine, was made to the same quality and is free of contaminants.

The vaccine is being manufactured at two sites in suburban Melbourne. CSL-Behring Australia in Broadmeadows are manufacturing the active raw vaccine material, while the final vaccine doses are being manufactured, vials filled and packaged at Seqirus in Parkville (a CSL company). Quality control testing of the raw material and product is also being carried out in these facilities.

The final step for the Australian-manufactured vaccine is TGA batch release, which is required for each and every batch of any vaccine supplied in Australia. This involves a review of documents supplied by the commercial sponsor describing how the vaccine batch was made, tested, shipped and stored as well as TGA's in-house laboratory testing to ensure the vaccine has been manufactured according to the required standards.

Receipt of the final batch release documentation from AstraZeneca is anticipated imminently and it is anticipated that the first batches will be released in the next few days.

The Australian Government has purchased 50 million doses of the AstraZeneca vaccine, to be manufactured on their behalf by CSL, and, subject to individual batches passing TGA batch release requirements, these will form the mainstay of Australia's COVID-19 vaccination program over the coming months, and complement imported vaccine supplies.

As part of Phase 1B of Australia's COVID-19 vaccine program, more than 1,000 general practices will join the COVID-19 vaccination program from tomorrow. These clinics have initially been supplied with imported AstraZeneca vaccine. Clinics will progressively increase in number to more than 4,000 by the end of April, along with over 100 Aboriginal Health Services and 130 Commonwealth operated GP-led Respiratory Clinics. This staged scale up aligns with the supply of the locally-produced AstraZeneca vaccine.

Source:

https://www.tga.gov.au/media-release/tga-approves-csl-seqirus-manufacture-astrazeneca-covid-19-vaccine-australia

" CSL celebrates 10 Decades in 10 Weeks

The final years of our series, 2016-2021, sees CSL’s further expansion in R&D and manufacturing, acquisitions and partnerships and a role in Australia’s COVID-19 pandemic response.

In 2017, CSL acquires both a majority stake in Chinese plasma fractionator, Ruide, as well as biotech company, Calimmune, providing a promising gene therapy platform. In 2018, CSL112, CSL’s cardiovascular disease product, moves into Phase III clinical trials; and an expansion of the Bio21 Institute in Parkville is officially opened.

In 2019, CSL celebrates 25 years as a listed company on the Australian Securities Exchange and announces the development of the new CSL Australian Headquarters in the heart of Melbourne’s Biomedical Precinct. In 2020, CSL fully acquires biotechnology company Vitaeris, specifically its late-stage monoclonal antibody therapy to address long-term rejection in kidney transplants.

With COVID-19 gripping the world, CSL partners with the University of Queensland on the development and manufacture of a novel vaccine; forming and leading an unprecedented global industry alliance to develop a hyperimmune treatment for the most serious cases; and manufacturing the Oxford/AstraZeneca vaccine for the Australian population. "

Source: LinkedIn

2 March 2021

From the Interview with Marcus Bogdan from Blackmore on livewiremarkets.

"CSL was the most intriguing result in the reporting season. It delivered a result that was about 20% above forecast, but they were very, very cautious on their forward outlook, maintaining guidance of 3-8% net profit growth.

We do think that they will ultimately upgrade that guidance, but I thought it'd be interesting to just talk through some of the drivers in CSL, given that it's been a doyen of Australian investors' portfolios for a number of years. And the business is really in two parts.

The largest component is plasma therapies, and that has got long term growth prospects of around 8-10%. The pipeline is very strong, but what's happened in COVID is it's the supply of plasma through collection centres, the largest market being the United States, has been constrained, and that has put pressure on that business, but there's a number of offsets that they're using to support that market. One is that they've got excess inventory. Two, the regulator has allowed a holding period to be reduced, and three, they're also seeing quite significant price rises in that market.

We expect that that market will remain challenged for the next few months, but as the vaccine is further rolled out, particularly in those Northern Hemisphere countries, in particular the US, we will start to see people coming back to collection centers, donating plasma, and helping with supply there. The second part of their business, which has been a huge beneficiary of the pandemic, has been their vaccine business. There has been unprecedented for flu vaccinations, not only in Australia but also in the Northern Hemisphere, in the winter that they've just come through.

But also our channel checks of CSL is that the future demand for the next flu season in the Northern Hemisphere has been unprecedented again. So, we'll start to see both a further uplift in volumes for their flu business, and also the mix of their product range will also see a range of price increases there. So, we remain very constructive of CSL in the portfolio. We've recently added to our position there as the prices have been weaker, and we think it remains a core portfolio stock.

..."

Quick Update:

The Therapeutic Goods Administration has given a second coronavirus vaccine the green light, as Australians anxiously await the rollout of the vaccination program.

The medical regulator announced today it had granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia after approving the Pfizer vaccine in January.

It means the jab is provisionally approved and included in the Australian Register of Therapeutic Goods for the immunisation of individuals 18 years and over, with the vaccination of those aged over 65 should be decided on a case-by-case basis.

The exciting news broke during Victoria’s daily COVID-19 press conference, and chief health officer Brett Sutton said it was “terrific news”.

(https://www.news.com.au/world/coronavirus/health/astrazeneca-coronavirus-vaccine-provisionally-approved-by-tga/news-story/6189ce007611de11779b198b4253505a)

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According to my research:

Pfiser/Moderna vaccines are $30/2 jabs; AstroZeneca is $5/2 jabs

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Yesterday, CSL has announced the final stages of manufacturing of the AstraZeneca COVID-19 vaccine for Australia will commence from today. The first doses of the vaccine are on track for release towards the end of March, subject to approval by the Therapeutic Goods Administration (TGA).

(Source: Linkedin)

Earlier last week, the vaccine was approved by the Office of the Gene Technology Regulator. It's currently under review at the Therapeutics Good Administration.

"The AstraZeneca vaccine is what's known as a biological. It needs the help of living organisms to be produced.

Loads of pharmaceuticals are produced this way, including vaccines. The HPV vaccine, for instance, which protects against cervical cancer, is one.

The AstraZeneca COVID-19 vaccine relies on a type of cell called HEK 293. These cells were originally taken from a human embryo kidney — hence HEK — back in the 1970s. They grow well in labs and are a commonly used component in drug manufacturing.

HEK cells don't actually end up in the vaccine. Instead, they cultivate the crucial part of the vaccine — the adenovirus, which carries the spike protein DNA blueprint.

So the first step in making the AstraZeneca vaccine is to grow an army of HEK cells.

Just as you might get sourdough starter from a friend, AstraZeneca, in November, supplied CSL with tiny frozen tubes, each holding a mere millilitre of HEK cells.

CSL's job was to take these smidgens and get them multiplying to fill the equivalent of a small water tank."

(Source: https://www.abc.net.au/news/science/2021-02-12/covid-19-vaccine-oxford-astrazeneca-adenovirus-csl-manufacturing/13140104?utm_medium=content_shared&utm_source=abc_news_amp&utm_campaign=abc_news_amp&utm_content=mail)

Disclaimer: I hold CSL shares

An interesting article in today's The Age:

" Biotechnology giant CSL says it may review its capacity to make an alternative coronavirus vaccine made by US firm Novavax in Australia but has emphasised all of its resources are currently tied up in making the AstraZeneca product.

...

The focus on new supply deals prompted reports including in The Daily Telegraph that Melbourne-based CSL might be able to locally manufacture the protein vaccine designed by US biotechnology company Novavax.

The $123 billion blood plasma products maker has said at this stage it has focused all of its resources on making the AstraZeneca vaccine onshore, though it would re-evaluate its manufacturing capabilities if the government requested this once the production of the 50 million AstraZeneca vaccine doses was complete. Given current timelines, this might not be until the end of 2021."

CSL Delivers a Full Year Net Profit of over $1.9 Billion

A strong year for CSL with reported net profit after tax of $1,919 million, up 17% at CC and revenue up 11% at CC, reflecting;

•      Continued strong growth in immunoglobulin and albumin therapies
•      High patient demand for specialty products Haegarda & Kcentra
•      Successful evolution of the haemophilia therapies portfolio
•      Seqirus delivering on strategy, with strong profit growth  

    
Earnings per share $4.236, up 16% at CC

Final dividend of US$1.00 per share (approximately A$1.48)

•     Total full year dividend increased to US$1.85 per share, up 8%     
•     Converted to Australian currency, the total full year dividend is approximately A$2.68 per share, up 18%

FY20 net profit after tax anticipated to be in the range of approximately $2,050 million to $2,110 million at CC representing a growth over FY19 of approximately 7-10%. This growth takes into account the one-off financial headwind of transitioning to a new model of direct distribution in China.

There is an interesting article at livewiremarkets.com that CSL is likely to perform well in 2020 FY.

CSL influenza vaccine business Seqirus has moved from an EBITDA loss of c.USD$245m in FY16 to an expected EBITDA profit of US$200m in FY20.

The full article can be found here:

https://www.livewiremarkets.com/wires/csl-delivers-an-extraordinary-transformation?utm_medium=email&utm_campaign=Trending%20on%20Livewire%20-%20Friday%2026th%20July%202019&utm_content=Trending%20on%20Livewire%20-%20Friday%2026th%20July%202019+CID_d956008ed7d572688f900e44e5cf1781&utm_source=Campaign%20Monitor&utm_term=READ%20MORE