Koura (formerly Mexichem Fluor) announced that the FDA has cleared the company’s IND for Zephex HFA 152a MDI propellant, and the company plans to initiate clinical trials of the propellant this month. In December 2019, Chiesi announced that it intended to bring a Zephex 152a inhaler to market by the end of 2025.
At DDL 2016, Koura presented data suggesting the possible use of HFA 152a as an MDI propellant, citing its reduced global warming potential (GWP) and potential for enhancing the stability of some APIs. The GWP of HFA 152a is 90% less than that of HFA 134a. By DDL 2019, the possibility of a switch from HFA 134a to HFA 152a had become a major topic of discussion.
Koura President Sameer Bharadwaj commented, “Koura has a proud history of innovation, and these forthcoming clinical trials in the United States mark an important milestone in delivering a solution that balances product efficacy and environmental stewardship. Supplying this critical technology to the many millions of patients who suffer from asthma moves the needle on sustainable care and conscientious development throughout our industry.”
The company has announced a “multimillion-pound investment” into a new laboratory facility, which it says is “the first in the world to offer dedicated pharmaceutical-grade laboratories specializing in the commercial development of 152a-based inhaled medicines.”
Read the Koura press release.
