CSL LTD SP/ADR - CSLLY STOCK NEWS

Seqirus, a leader in influenza prevention and part of CSL Limited (ASX:CSL), announced the launch of a dedicated self-amplifying messenger RNA (sa-mRNA) vaccine program. This initiative aims to advance the development of influenza vaccines, with clinical trials for seasonal and pandemic vaccine candidates expected to begin in the latter half of 2022. The company has appointed Roberta Duncan as Vice President, mRNA Program Lead, to oversee this initiative. Sa-mRNA technology is projected to improve vaccine effectiveness and reduce dosage requirements, enhancing public health responses to influenza.

CSL Behring announced an update from the EAN and PNS Task Force on CIDP treatment guidelines, recommending subcutaneous immunoglobulin (SCIg) for maintenance therapy. This marks the first inclusion of SCIg in the guidelines since 2010, reflecting its evidence-based efficacy. The guideline specifies that SCIg dosage should be individualized and advises against its use for induction treatment. Hizentra, CSL Behring's SCIg product, remains the most prescribed treatment for CIDP. This update is expected to empower physicians in managing CIDP, enhancing patient convenience and potentially reducing treatment side effects.

CSL Behring has received FDA approval for a supplemental request to co-package a convenience administration kit with its product, BERINERT, for treating hereditary angioedema (HAE) attacks. This packaging will enhance patient experience by simplifying access to necessary infusion supplies, reducing distribution complexities for pharmacies. BERINERT, the only approved C1 esterase inhibitor for acute HAE attacks, will now include a 10 mL silicone-free syringe, IV set, and butterfly needle, expected to be available in the third quarter of 2021.

Seqirus, a CSL Limited business, presented an observational study at the IDSOG Meeting on July 30, 2021, revealing no unexpected adverse pregnancy outcomes among those vaccinated with the QIVc influenza vaccine during pregnancy. The study, involving 665 pregnant participants, showed no adverse fetal outcomes, supporting the vaccine's safety. QIVc, which uses a cell-based manufacturing process, is under FDA review for expanded age indications. Seqirus aims to enhance vaccine production capabilities with state-of-the-art facilities in the U.S. and plans for a new plant in Australia.

Seqirus has begun shipping its innovative seasonal influenza vaccines across the U.S. for the 2021/22 influenza season, aiming to meet record demand from the previous year. The company plans to supply approximately 60 million doses of vaccines, including FLUCELVAX^® QUADRIVALENT and FLUAD^® QUADRIVALENT, which cater to different age groups. The CDC recommends annual vaccination for those six months and older, emphasizing the importance of flu vaccinations amidst the ongoing COVID-19 pandemic.

Seqirus, a division of CSL Limited (ASX: CSL), co-authored a landmark study demonstrating the safety and efficacy of co-administering its seasonal influenza vaccine with Novavax's COVID-19 vaccine (NVX-CoV2373). Conducted in the UK, the Phase 3 trial involved 431 participants and found no additional safety concerns with the combination, suggesting potential for improved vaccine uptake. Despite promising results, limitations include a small sample size and lack of formal statistical assessments. The study aims to inform future vaccine guidelines as the influenza season approaches.

CSL Behring announced the approval of Hizentra for Medicare Part B coverage for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) effective July 18, 2021. This new coverage will reduce out-of-pocket expenses for patients, including costs for self-infusion pumps, supplies, and training. Previously covered under Medicare Part D, patients faced higher costs. The decision simplifies access for physicians as no prior authorization is needed, enhancing patient access to treatment options and aligning with CSL's commitment to improving patient care.

CSL Behring announced findings from a meta-analysis of seven Phase 3 trials involving over 82,000 patients with recent acute coronary syndrome (ACS). The analysis revealed that 49% of recurrent major adverse cardiovascular events (MACE) occurred within the first 90 days after an ACS event. The results highlight the criticality of this early period for high-risk patients. CSL Behring is advancing its Phase 3 AEGIS-II study to assess the efficacy of CSL112 in reducing MACE risk following heart attacks, aiming to enhance patient protection during this vulnerable timeframe.