According to Pulmatrix, a dispute between Pulmatrix and Cipla over funding related to the development of Pulmazole intraconazole DPI (PUR 1900) has been resolved. In May 2021, Pulmatrix announced that Cipla had failed to provide 50% of the development costs for Pulmazole and had therefore breached the terms of their development and commercialization agreement for the DPI, an agreement that had been signed in 2019.
In the May 2021 announcement, Pulmatrix noted that it had completed a Type C meeting with the FDA in February 2020 and said that it intended to initiate a Phase 2b trial of Pulmazone in patients with allergic bronchopulmonary aspergillosis (ABPA) in the first quarter of 2022. A previous Phase 2 trial in patients with ABPA was initiated in July 2019 and was terminated in July 2020 due to the COVID-19 pandemic.
Pulmatrix says that Cipla will now reimburse only 40% of direct costs related to Pulmatrix personnel and will reimburse 50% for third-party costs only at this time. Cipla will reimburse an additional 10% of the direct costs when certain milestones are met, including dosing of a quarter of trial participants in the planned Phase 2b study by June 30, 2023 and delivery of top line results from the trial by June 30, 2024. In the case that Pulmatrix fails to meet those milestones within 9 months of the expected dates, the agreement may be terminated.
Cipla has also agreed to pay 2% royalties on net sales in exchange for the exclusive development and commercialization rights to Pulmazole in India, Nepal, Yemen, Iran, South Africa, Sri Lanka, Myanmar, and Algeria.
Pulmatrix CEO Ted Raad said, “We are pleased to have come to this resolution which will enable the continued development of Pulmazole globally with our valued partners at Cipla. After a successful Type C meeting with the FDA, we are now ready to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA while avoiding the side effects of oral antifungals and prolonged steroid treatment.”
Read the Pulmatrix press release.
