Cycle Pharmaceuticals (“Cycle”), a global pharmaceutical company focused on rare diseases, and Forma Life Sciences, Inc. (“Forma”), a U.S. contract development and manufacturing organization, today announced a commercial manufacturing agreement for CAVHANZA™ (nilotinib) orally disintegrating tablets.

CAVHANZA is an FDA-approved treatment for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Under the agreement, Forma will manufacture CAVHANZA at its facilities in Irvine, California, establishing a U.S. commercial supply as Cycle prepares to introduce the product to the U.S. market.

“Establishing U.S. manufacturing for CAVHANZA is an important step in our preparations to bring this differentiated treatment to patients,” said Catherine Wainwright, Chief Operations & Regulatory Officer at Cycle Pharmaceuticals. “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.”

CAVHANZA was developed to address important administration challenges associated with conventional nilotinib products. CAVHANZA can be administered with proton pump inhibitors and H₂ receptor antagonists without timing restrictions.¹ This addresses a known treatment challenge in Ph+ CML, where 47% of patients are prescribed PPIs at some point after diagnosis, potentially affecting treatment bioavailability.²

Clinical studies also demonstrated no food effect, allowing CAVHANZA to be taken without regard to mealtimes.¹Additionally, as an orally disintegrating tablet, CAVHANZA can be taken with or without water – potentially providing an option to patients who have difficulty swallowing tablets.¹

Forma will manufacture CAVHANZA using ElectroNanoSpray™, a proprietary, non-thermal particle engineering technology developed by Flex Pharma, LLC and designed to produce highly uniform amorphous drug particles. Forma has supported the product through its progression toward commercial manufacturing and will provide ongoing manufacturing services under the new agreement with Cycle.

“We are proud to support Cycle as it prepares to introduce CAVHANZA in the United States,” said Armand Amin, President of Forma Life Sciences. “Our team is excited to bring its experience in complex oral drug products and commercial manufacturing to this important launch.”

The agreement builds on Cycle’s preparations for the U.S. commercialization of CAVHANZA and Forma’s continued investment in domestic development and commercial manufacturing capabilities. Forma supports pharmaceutical and biotechnology companies across formulation development, analytical services, clinical manufacturing and commercial supply, including programs using 505(b)(2) regulatory pathways.