IRVINE, Calif. — Cycle Pharmaceuticals and Forma Life Sciences, Inc. have entered into a commercial manufacturing agreement to establish U.S. production of CAVHANZA™ (nilotinib) orally disintegrating tablets.
CAVHANZA is approved by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML.
Under the agreement, Forma will manufacture CAVHANZA at its facilities in Irvine, California, as Cycle prepares to introduce the treatment in 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 administration challenges associated with conventional nilotinib products. According to Cycle, the drug can be administered with proton pump inhibitors and H2 receptor antagonists without timing restrictions.
The company said this could address a treatment challenge for patients with Ph+ CML who also use proton pump inhibitors, which can affect the bioavailability of some treatments.
Clinical studies also showed no food effect, allowing CAVHANZA to be taken without regard to mealtimes. Because it is an orally disintegrating tablet, the drug can also be taken with or without water, potentially offering another option for patients who have difficulty swallowing tablets.
Forma will manufacture CAVHANZA using ElectroNanoSpray™, a proprietary non-thermal particle engineering technology developed by Flex Pharma, LLC that is designed to produce uniform amorphous drug particles.
Forma has supported development of the product as it progressed toward commercial manufacturing and will continue providing manufacturing services under the new agreement.
“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.”
Forma provides formulation development, analytical services, clinical manufacturing and commercial supply services to pharmaceutical and biotechnology companies, including programs using the 505(b)(2) regulatory pathway.
