CSL LTD SP/ADR - CSLLY STOCK NEWS

Seqirus, a global influenza vaccine leader under CSL Limited, has completed a $156 million expansion of its manufacturing facility in Holly Springs, N.C. The new line for pre-filled syringes has received FDA approval and will enhance the production of FLUCELVAX® QUADRIVALENT, the only cell-based quadrivalent influenza vaccine in the U.S. The expansion supports over 80 skilled jobs and increases capacity for seasonal vaccines and pandemic readiness. Seqirus aims to respond better to the growing demand for differentiated influenza vaccines.

Seqirus has successfully achieved recognition from the U.S. government for its manufacturing facility in Holly Springs, North Carolina, confirming its capability to produce innovative cell-based seasonal and pandemic influenza vaccines. This facility can deliver 150 million doses within six months of a pandemic declaration. Seqirus previously developed the first adjuvanted, cell-based influenza A(H5N1) vaccine. The Holly Springs site is the largest of its kind globally and is integral to the U.S. pandemic preparedness strategy. Ongoing investments aim to enhance manufacturing capacity and production speed.

The FDA has accepted CSL Behring's Biologics License Application for priority review of etranacogene dezaparvovec, a gene therapy for adults with hemophilia B. This therapy targets the genetic cause of hemophilia B, potentially allowing for near-normal blood clotting. Clinical trials showed a 64% reduction in annual bleeding rates after treatment. Approval could mark the first gene therapy for hemophilia B, enhancing CSL Behring's commitment to innovative treatments for rare diseases. The review process is expected to take six months.

CSL Limited (ASX: CSL; USOTC: CSLLY) announced an update on its acquisition of Vifor Pharma AG, originally expected to close by June 2022. While some antitrust approvals have been received, others are still pending. CSL reassured shareholders that such delays are common and that they are collaborating with remaining authorities for timely resolution. A precise closing date will be communicated once all regulatory approvals are confirmed, and CSL remains confident in finalizing the acquisition.

Walter Charles has been appointed as Senior Vice President and General Manager of CSL Plasma, effective May 1, 2022. He will lead the organization in expanding its plasma collection operations, crucial for producing life-saving therapies. CSL Plasma manages over 300 collection centers globally and employs more than 13,000 staff. Charles previously served as the global Chief Procurement Officer for CSL. His appointment is expected to enhance donor engagement and operational excellence across the company's extensive plasma network.

CSL Behring announced a significant donation of 500 million international units (IUs) of coagulation factor therapy to the World Federation of Hemophilia (WFH). This initiative aims to improve access to treatment for individuals with bleeding disorders in over 60 developing countries. The therapy is specifically manufactured for donation, ensuring a three-year shelf life. Alongside this donation, CSL Behring also commits to provide an additional 50 million IUs over the next three years. This collaboration supports WFH's efforts to enhance diagnosis and treatment of these conditions globally.

CSL Behring's Marketing Authorization Application (MAA) for etranacogene dezaparvovec has been accepted for accelerated assessment by the EMA, potentially making it the first gene therapy for hemophilia B. Supported by the phase 3 HOPE-B study, which showed a 64% reduction in annual bleeds after a single infusion, this breakthrough therapy aims to significantly improve patients' lives. Etranacogene dezaparvovec addresses the underlying genetic cause of hemophilia B, offering hope for a transformative treatment option in the EU and EEA.

CSL Behring AG, a subsidiary of CSL Limited (ASX: CSL; USOTC: CSLLY), announced the end result of its public tender offer to acquire Vifor Pharma Ltd. for USD 179.25 per share. As of March 22, 2022, CSL's stake in Vifor Pharma reached 93.9%, subject to certain conditions. CSL intends to facilitate Vifor Pharma's de-listing and a squeeze-out of remaining shareholders. The offer's settlement is expected around mid-2022, pending regulatory approvals. Further details can be found at csltransaction.com.

CSL Behring AG, a subsidiary of CSL Limited (ASX: CSL; USOTC: CSLLY), announced a provisional result regarding its public tender offer for Vifor Pharma Ltd. The offer of USD 179.25 per share resulted in CSL acquiring 94% of Vifor Pharma shares as of March 22, 2022. The definitive result will be published on March 28, 2022, confirming the fulfillment of offer conditions. CSL has waived the 80% acceptance rate requirement, declaring the tender offer successful. Vifor Pharma specializes in treatment solutions for iron deficiency and nephrology.