VarmX has established a partnership with CSL for the development of VMX-C001, designed to aid in restoring blood coagulation in those who need urgent surgery or are facing severe bleeding while they are on factor Xa direct oral anticoagulants (FXa DOACs).
Additionally, CSL has secured an exclusive option to purchase all the issued and outstanding shares of VarmX.
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As part of the collaboration, CSL will fully finance the worldwide Phase III EquilibriX-S study, which will test the therapy in those on FXa DOACs who need urgent surgical procedures.
VarmX noted that CSL will cover the costs of late-stage product development, manufacturing, and pre-launch commercial and medical affairs activities.
An upfront payment of $117m will be made to VarmX shareholders by CSL upon the transaction closure, granting the latter the exclusive option to acquire the company.
CSL CEO Dr Paul McKenzie said: “We are excited to partner with VarmX to develop a novel treatment and address a significant unmet need, aligning strongly with our strategic ambition to deliver enduring patient impact.
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By GlobalData“It also aligns with our portfolio of medicines designed to minimise bleeding, preserve a patient’s own blood supply, improve surgical and medical outcomes and support global public health approaches to patient blood management.”
CSL will be eligible to exercise this option based on the data from the Phase III study.
If certain milestones are met, and following customary regulatory approvals, shareholders of VarmX could get an additional $388m in acquisition payments, as well as up to $1.7bn in sales-based success milestones after the commercial launch of the therapy.
UBS is serving as VarmX’s exclusive financial adviser, with NautaDutilh providing legal counsel.
The US Food and Drug Administration (FDA) has awarded VMX-C001 fast track status, acknowledging its potential to meet an unmet medical need for those on FXa DOACs needing urgent surgery.
The anticipated launch of the treatment commercially is set for 2029.
