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CSL Limited ADR news reflects developments from a global biopharma company focused on plasma-derived therapies, vaccines and biotechnology medicines. Recurring updates cover CSL Behring, CSL Seqirus and CSL Vifor activities, including hemophilia and immune-deficiency therapies, influenza vaccines, iron-deficiency and nephrology treatments, and hereditary angioedema products.
Company news also includes clinical data and regulatory decisions for products such as HEMGENIX, ANDEMBRY and FILSPARI, manufacturing investments tied to plasma-therapy capacity and advanced production processes, and ADR program administration for the U.S. over-the-counter security.
CSL Seqirus, a global leader in pandemic preparedness, has received a $34 million award from the Biomedical Advanced Research and Development Authority (BARDA) to complete the fill and finish process for additional pre-pandemic vaccines. This marks the sixth avian influenza pandemic preparedness award from BARDA to CSL Seqirus. The company will deliver approximately 3 million finished doses of MF59®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen.
CSL Seqirus' manufacturing facility in Holly Springs, North Carolina, is the largest cell-based influenza vaccine producer in the world. It can deliver 150 million influenza vaccine doses within six months of a pandemic declaration. This project is supported by federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.
CSL Seqirus presented real-world evidence (RWE) studies at OPTIONS XII, showcasing the effectiveness of influenza vaccinations. Key findings include:
1. Cell-based vaccines showed improved relative vaccine effectiveness (rVE) compared to egg-based vaccines across different age groups, including children as young as six months.
2. A 2023/24 season study revealed cell-based vaccine effectiveness was highest in children 6 months to 3 years at 88% against laboratory-confirmed influenza.
3. MF59® adjuvanted quadrivalent vaccine showed comparability to high-dose quadrivalent vaccine in preventing flu-related ER visits and hospitalizations for adults 65+.
These studies highlight CSL Seqirus' commitment to evaluating vaccine effectiveness through RWE, complementing randomized controlled trials and providing ongoing insights into real-world outcomes.
CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.
Key findings include:
- ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
- Similar advantages were observed against Omicron BA.4-5 and other variants
- A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®
The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.
CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:
1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.
2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).
3. Superior durability of immune response in both younger and older adults.
Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.
CSL Seqirus, a business of CSL (ASX: CSL), has received a $121.4 million multi-year award from the Biomedical Advanced Research and Development Authority (BARDA) to expand its Vendor Managed Inventory (VMI) program for MF59® adjuvant. This marks the fifth avian influenza pandemic preparedness award for CSL Seqirus. The expanded program will increase the inventory to 40 million equivalent doses, enhancing the U.S. government's pandemic preparedness efforts.
MF59® adjuvant, manufactured at CSL Seqirus' Holly Springs, North Carolina facility, is important for pandemic preparedness as it reduces the antigen required to produce an immune response, thereby increasing vaccine doses. This expansion comes in response to sustained highly pathogenic avian influenza (HPAI) activity, which the CDC reports is widespread in wild birds and causing outbreaks in poultry and U.S. dairy cows.
CSL Vifor announced that Japan's Ministry of Health and Labor Welfare (MHLW) has approved Veltassa® (patiromer) for treating hyperkalemia in adult patients. This approval, granted to CSL Vifor's partner Zeria Pharmaceutical Co., , marks Veltassa®'s 41st country authorization worldwide.
Veltassa® offers effective long-term potassium control for patients with chronic kidney disease and chronic heart failure. The approval is based on positive clinical data from the Japanese development program of ZG-801 (Veltassa®).
This milestone addresses the needs of over 300,000 hyperkalemia patients in Japan. Zeria, which obtained exclusive rights to develop and market Veltassa® in Japan in 2018, plans to launch the product following National Health Insurance price listing.
CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.
KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.
CSL Seqirus, a CSL business, has commenced shipping its influenza vaccines for the 2024/25 flu season. The company is the only manufacturer in the U.S. to offer a differentiated range of influenza vaccines for individuals aged six months and older. This year, the vaccines are available in trivalent formulations following FDA guidelines. The portfolio includes FLUCELVAX®, a cell-based vaccine; FLUAD®, an adjuvanted vaccine for seniors; and AFLURIA®, an egg-based vaccine. CSL Seqirus aims to address the declining flu vaccination rates, which have dropped significantly in recent years, posing a public health risk. The CDC recommends annual flu vaccinations, especially for high-risk groups such as the elderly, pregnant individuals, and young children. The company is focused on reversing this trend and supporting healthcare providers in increasing vaccination rates.
CSL Seqirus has been awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to produce 4.8 million doses of pre-pandemic H5N1 vaccine for the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This is the fourth such award for CSL Seqirus, reinforcing its role in pandemic preparedness. The company's Holly Springs, NC facility, built through a public-private partnership with BARDA, can produce up to 150 million doses within six months of a pandemic declaration. The facility is the largest cell-based influenza vaccine producer globally.