New York-based Progenics last year picked up an FDA approval for its orphan radiotherapeutic. Now it has picked up a manufacturing facility to produce it in.
The company on Monday announced it had acquired the Somerset, New Jersey, manufacturing facility for Azedra (iobenguane I 131) for $8 million in cash. It also nailed down a long-term supply of iodine needed for the production of both Azedra and 1095, another radiopharmaceutical under development.
The FDA in July approved the treatment as the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, two ultra-rare cancers.
The production of Azedra uses a proprietary process that the company says concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic “cold” MIBG molecules. The treatment pairs a small-molecule treatment with an imaging isotope, used in small doses to spotlight tumors and then dialed up to attack them. The FDA last year delayed the PDUFA date of Azedra by three months so that it could more thoroughly understand the chemistry, manufacturing and controls processes behind it.
“This strategic transaction extends our leadership position in radiopharmaceuticals, establishing the infrastructure and manufacturing capabilities to label multiple types of isotopes, including iodine-131,” Mark Baker, CEO of Progenics said in a statement. “With this transaction, we are building the capabilities to ensure the supply of Azedra.”
Progenics is initially targeting the 20 to 25 treatments where the drug was given in clinical trials, so are familiar with this type of therapy. Its label requires patients to have a tumor-locating scan.
Progenics also is looking toward future indications for the product. The company believes it can take the drug into areas where “MIBG scans are going to be positive for patients, which will include many other tumor types,” Baker has said.
Feb 12, 2019