- Cycle Pharmaceuticals has entered into a commercial manufacturing agreement with Forma Life Sciences to manufacture CAVHANZA™ (nilotinib) orally disintegrating tablets in Irvine, California.
- The agreement supports Cycle’s preparations to commercialize the FDA-approved treatment for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the United States.
Cycle Pharmaceuticals has entered into a commercial manufacturing agreement with Forma Life Sciences for the production of CAVHANZA™ (nilotinib) orally disintegrating tablets, an FDA-approved treatment for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Under the agreement, Forma will manufacture the product at its facility in Irvine, California, establishing a U.S.-based commercial supply as Cycle prepares to launch the therapy in the United States.
The agreement expands the companies’ collaboration, with Forma continuing to support commercial production following its earlier involvement in the product’s development. The contract manufacturing arrangement will utilize Forma’s ElectroNanoSpray™ particle engineering technology to manufacture the orally disintegrating tablet formulation. Forma also provides formulation development, analytical services, clinical manufacturing, and commercial supply for pharmaceutical and biotechnology companies.
“Establishing U.S. manufacturing for CAVHANZA is an important step in our preparations to bring this differentiated treatment to patients. We are pleased to work with Forma and draw on its experience in complex oral drug product manufacturing as we prepare to introduce CAVHANZA in the United States.”
Catherine Wainwright, Chief Operations & Regulatory Officer at Cycle Pharmaceuticals
According to the companies, CAVHANZA was developed to address administration challenges associated with conventional nilotinib products. The therapy can be administered with proton pump inhibitors and H2 receptor antagonists without timing restrictions, has demonstrated no food effect in clinical studies, and can be taken with or without water as an orally disintegrating tablet.
The agreement supports Cycle’s U.S. commercialization plans for CAVHANZA while expanding Forma’s role as a CDMO providing commercial manufacturing services for complex oral drug products.
