SOFIE, a Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, has signed a commercial supply agreement with Lantheus Holdings, Inc. (the parent company of Progenics Pharmaceuticals, Inc. [Progenics]) to manufacture and distribute Lantheus' lead investigational prostate cancer imaging agent, PyL™ (18F-DCFPYL).
Following U.S. Food and Drug Administration ("FDA") approval, Lantheus will have a critical need for dependable and scalable manufacturing and distribution partners to support PyL™. Under the commercial supply agreement, SOFIE will roll out PyL™ via its national network, which has manufactured PyL™ for Progenics during the clinical trials. SOFIE's network will help meet the expected commercial demand for PyL™ by leveraging its expertise, experience, and distribution capabilities to achieve widespread availability and market coverage.
SOFIE's CEO, Patrick Phelps stated, "Our relationship with Progenics, and now Lantheus, as well as our network capabilities have been greatly refined over the years we've worked on PyL™. With over 500 doses previously manufactured for Progenics' clinical trials, SOFIE is committed to delivering the doses needed, for widespread use post-FDA approval." SOFIE's Chief Technical Officer, Dr. Melissa Moore, added, "Solidifying our relationship with Lantheus via this commercial agreement is the next step in the evolution of our Radiopharmaceutical Contract Manufacturing Organization. SOFIE believes that PyL™ will be an important next generation prostate cancer diagnostic tool and will offer new opportunities to those suffering from this common form of cancer."
Paul Blanchfield, Lantheus Chief Commercial Officer commented, "We are delighted to partner with SOFIE as we work toward FDA approval to bring PyL™ to the U.S. prostate cancer community. Consistent, reliable, and on-time delivery of diagnostic PET imaging agents is critical to meeting our supply demands and we look forward to our continued partnership with SOFIE to help patients gain access to PyL™."Back To Top
SOFIE to Manufacture, Distribute Lantheus' Prostate Cancer Imaging Agent PyL. Appl Radiol.