On November 9, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has completed an amendment to Pulmatrix’s agreement with Cipla Technologies, LLC ("Cipla") for the development and commercialization of Pulmazole (Press release, Pulmatrix, NOV 9, 2021, View Source [SID1234595208]). The completion of the amendment resolves Pulmatrix’s previously disclosed dispute with Cipla regarding the continued funding of the development costs for Pulmazole.
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Pursuant to the 2nd Amendment Cipla will continue to reimburse Pulmatrix for 50% of all third-party costs for the development of Pulmazole, provided Cipla will only be required to reimburse Pulmatrix for 40% of Pulmatrix dedicated personnel and consulting costs ("direct costs"). Upon the timely achievement of certain development milestones, Cipla will reimburse another 10% of Pulmatrix’s "direct costs". The development milestones for Pulmatrix’s planned Phase 2b clinical trial include the dosing of 25% of participants in the clinical trial by June 30, 2023, and the delivery of top-line data results to the joint steering committee for the program by June 30, 2024. If the development milestones are not achieved within 9-months of such dates either party may terminate its obligation to fund its share of development costs. Pulmatrix also granted Cipla exclusive rights to the development and commercialization of Pulmazole in the "Cipla Territory" (India, Nepal, Yemen, Iran, South Africa, Sri Lanka, Myanmar and Algeria) in exchange for, under certain circumstances, 2% royalties on net sales of Pulmazole in the Cipla Territory. For more information about the 2nd Amendment please refer to Pulmatrix’s Current Report on Form 8-K to be filed with U.S. Securities and Exchange Commission on or around the date of this press release.
Pulmatrix successfully completed a Type C Meeting with the U.S. Food and Drug Administration (FDA) in February of 2020 and intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) with registration endpoints in Q1 2023 with topline data expected Q2 2024, which may enable a Phase 3 registration study.
"We are pleased to have come to this resolution which will enable the continued development of Pulmazole globally with our valued partners at Cipla," said Ted Raad, Chief Executive Officer of Pulmatrix. "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."