Profarma is currently developing advanced pharmaceutical forms and technologies for the treatment of cystic fibrosis as part of a project supported by European Union funding.
During this project, we plan to create and develop new ivacaftor pharmaceutical forms, including:

• Ivacaftor tablets
• Ivacaftor granules for pediatric use
• Ivacaftor extended-release tablets

These new ivacaftor products will enhance the accessibility and quality of cystic fibrosis treatment for patients in both regulated markets and developing countries.

Project Highlights:

• Project Value: €1,476,686.24
• Funding from the European Regional Development Fund: €833,867.07
• Project Duration: December 2023 – November 2026

Available strengths:

• Oral Granules: 25 mg, 50 mg, 75 mg

• Tablets: 75 mg, 150 mg

• Prolonged-release Tablets: 300 mg (under development)

Ivacaftor is a CFTR modulator indicated for the treatment of cystic fibrosis in patients with specific gating mutations. It enhances the function of the defective CFTR protein, improving chloride transport across cell membranes and supporting better respiratory outcomes.

This product is the generic equivalent to Kalydeco®, the reference product developed by Vertex Pharmaceuticals, which is a cornerstone in the treatment of cystic fibrosis. Kalydeco® is currently priced at approximately $300,000 per patient annually in the U.S.

Profarma’s Ivacaftor has been developed to meet stringent regulatory standards and is manufactured in an EU GMP-certified facility.

Contact us to explore licensing opportunities for your markets.