U.S. manufacturing agreement advances Cycle’s preparations to introduce CAVHANZA to patients with Philadelphia chromosome-positive chronic myeloid leukemia

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.¹ Additionally, 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.

About Forma Life Sciences

Forma Life Sciences is a U.S. contract development and manufacturing organization specializing in formulation development, analytical services and commercial manufacturing of oral solid dosage products. The company supports pharmaceutical and biotechnology companies from development through commercial supply, with expertise in spray drying, hot melt extrusion, particle engineering technologies and complex oral solid dosage manufacturing.

For more information, visit www.formalifesciences.com.

About Cycle Pharmaceuticals

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Detroit, Michigan.

For more information, please visit www.cyclepharma.com and follow on X, LinkedIn and Facebook.

About CAVHANZA

CAVHANZA™ is an FDA-approved nilotinib orally disintegrating tablet for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia. CAVHANZA provides greater administration flexibility, including use with proton pump inhibitors or H₂ receptor antagonists without timing restrictions, and can be taken without regard to meals. CAVHANZA will be commercialized in the United States by Cycle Pharmaceuticals.

Warning: QT Prolongation and Sudden Deaths

Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments.

Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome.

Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors.

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.

Contraindications

CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Important Safety Information

Warnings and Precautions:

• Substitution between nilotinib products requires dose conversion to avoid medication errors.
• Monitor for myelosuppression; manage with dose adjustments or interruptions.
• Cardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk.
• Pancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations.
• Hepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly.
• Correct and monitor electrolyte abnormalities throughout treatment.
• Tumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment.
• Serious hemorrhage may occur; advise patients to report signs and symptoms of bleeding.
• Monitor for fluid retention and manage accordingly.
• Growth retardation has been reported in pediatric patients. Monitor growth and development.
• Can cause fetal harm; advise use of effective contraception during and 14 days after treatment.
• Monitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately.

Adverse Reactions:

Common non-hematologic adverse reactions include rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea and vomiting. Hematologic adverse reactions include thrombocytopenia, neutropenia, and anemia. Serious adverse reactions include QT prolongation, sudden deaths, febrile neutropenia, and intracranial hemorrhage. Postmarketing reports include thrombotic microangiopathy, facial paralysis, and osteonecrosis.

Drug Interactions:

Avoid concomitant use with strong CYP3A inhibitors or inducers. Dose reduction is recommended if strong CYP3A inhibitors cannot be avoided. Avoid drugs that prolong the QT interval, including anti-arrhythmics.

Use in Specific Populations:

Pregnancy: CAVHANZA can cause fetal harm when administered to a pregnant woman.

Lactation: Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose.

Pediatric use: CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used.

Due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Geriatric use: No major differences for safety were observed in patients ≥65 years taking CAVHANZA.

For more detailed information, please refer to the full Prescribing Information at https://cyclepharma.com/nilotinib-pi/

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

References:

1. CAVHANZA™ (nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma.
2. Larfors, G. et al. (2023). Despite warnings, co-medication with proton pump inhibitors and dasatinib is common in chronic myeloid leukemia, but XS004, a novel oral dasatinib formulation, provides reduced pH-dependence, minimizing undesirable drug-drug interactions. European journal of haematology, [online]. doi: https://doi.org/10.1111/ejh.14059.​

CAVHANZA™ and ElectroNanoSpray™ are trademarks of Flex Pharma, LLC.

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