Cipla Limited said that its fully-owned step-down subsidiary — Cipla Technologies (CipTec) has completed an amendment to a previously signed agreement with US-based Pulmatrix for the development and commercialization of Pulmazole.
Pulmatrix is a clinical stage biopharma company focused on developing inhaled therapies for addressing serious pulmonary and non-pulmonary diseases with its iSPERSE technology.
As per the second amendment made by the parties, CipTec will continue to compensate 50% of all third-party costs to Pulmatrix for the development of Pulmazole. This includes 40% of Pulmatrix dedicated personnel and consulting costs and another 10% of Pulmatrix’s direct costs after the timely achievement of certain development milestones.
According to Cipla Limited, the development milestones for the planned phase 2b clinical trial of Pulmatrix include the dosing of a quarter of participants in the clinical trial by 30 June 2023, and the release of top-line data results to the joint steering committee for the program by 30 June 2024.
Cipla Limited said that if the development milestones are not met within nine months of such dates, then either of the parties can end its obligation to fund its share of development costs.
Pulmatrix has also given exclusive rights to CipTec for the development and commercialization of Pulmazole in the “Cipla Territory”, which includes India, Nepal, Iran, Yemen, South Africa, Myanmar, Sri Lanka, and Algeria in exchange for, under certain circumstances, royalties of 2% on net sales of Pulmazole in the countries.
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