CSL Opens New Manufacturing Facility For Hemophilia Therapies
CSL, which is based out of King of Prussia, Pennsylvania, has announced that the company has opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. This new facility will be located directly adjacent to the company’s plant dedicated to manufacturing plasma products in Melbourne. The new expansion cost the company $250 million and was part of the overall expansion of the company’s Broadmeadows site. The new facility will be used primarily for the late stage development of hemophilia products. The advanced technology at the facility will allow for the large-scale production of therapies for international clinical trials.
Paul Perreault, the CEO of CSL, says, “This world-class facility is key to the ongoing success of our global R&D strategy and reflects our commitment to providing better treatment options for people who are managing certain bleeding disorders and other life-threatening conditions.”
The company has set its sights on further growing its recombinant factor development programs for the treatment of hemophilia A and B. CSL has several drug candidates to treat hemophilia A and B, including rVIII-SingleChain, rVIIa-FP, and rIX-FP. The first therapy to be manufactured at the Broadmeadows facility will be rVIIa-FP.
On May 11th, CSL presented interim pharmacokinetic data gleaned from two Phase III studies and its Phase I and I/II trials for the rIX-FP candidate at the World Federation of Hemophilia 2014 Congress. The results of the trial showed that hemophilia B patients treated with rIX-FP required less frequent dosing—only once every 14 days, while current treatments require a dosage two or three times each week. The trials were open-label, multicenter, safety and efficacy studies of the rIX-FP drug and its effect on patients previously treated for severe hemophilia B. The study’s aim is to alter the frequency of spontaneous bleeding events with different treatment regimens.
Elena Santagostino, the study’s lead researcher, commented on the results. “Our interim PK data from two Phase III studies, combined with the Phase I and I/II results, demonstrate that rIX-FP has the potential to satisfy this unmet need by offering a longer dosing interval and fewer injections,” she said. “Patients with hemophilia B and treating physicians are eager for innovative products that are able to decrease the dosing frequency while being effective and reliable in the prevention or treatment of bleeding episodes.”