'Green' Medical Propellant Receives FDA Approval to Proceed to Clinical Trials

BOSTON, Feb. 4, 2020 /PRNewswire/ -- Koura (previously known as Mexichem Fluor), a pioneer in the development of next generation propellants, today announced FDA approval to proceed to clinical trials with Zephex® 152a. This new medical propellant has been under development for several years for use in metered-dose inhalers (MDIs) for treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). Zephex® 152a reduces the carbon footprint of an MDI, helping to safeguard an invaluable therapeutic option for patients.

"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," said Sameer Bharadwaj, president of Koura. "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."

Global Warming Potential (GWP) is a measure of the atmospheric warming potential of a propellant upon release into the atmosphere. Pressurized metered-dose-inhalers using Zephex® 152a will bring about a greater than 90 percent reduction in GWP compared to some current MDI propellants². As a result, the use of Zephex® 152a will result in an environmental impact comparable to other 'green' technologies, including dry powder inhalers, when accounting for manufacturing, use and disposal. Utilization of the 152a molecule as a lower GWP inhaler propellant addresses concerns of both patients and pharmaceutical companies. ¹

Clinical trials with Zephex® 152a will take place in the United States and are expected to begin in February 2020 and conclude within Q1. Recognizing the value of Zephex® 152a, the Italy-based Chiesi Farmaceutici announced its intentions to develop Zephex® 152a-based inhalation products for launch in 2025. Koura has also committed to a multimillion-pound investment into a new laboratory facility in the UK; the first in the world to offer dedicated pharmaceutical-grade laboratories specializing in the commercial development of 152a-based inhaled medicines.

For more information, please visit http://kouraglobal.com.

Media Contact
Andrea McLoughlin, KWT Global
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About Koura
Koura (formerly Mexichem Fluor) is a global leader in the development, manufacture and supply of fluoroproducts that play a fundamental role in enhancing everyday lives. Koura is part of the Orbia community of companies, working together to tackle some of the world's most complex challenges. Koura's products are used in a vast range of applications including the construction of towns and cities, keeping homes cool, food fresh and even in the treatment of respiratory conditions, providing the medical propellant used in 80% of the world's metered dose inhalers (MDIs). Headquartered in Boston, Koura has commercial activities across the globe, with operations in the UK, Mexico, USA, Canada, India and Japan.

About Orbia
Orbia (BMV: ORBIA) is a community of companies bound together by a shared purpose: to advance life around the world. Orbia's business groups have a collective focus on insuring food security, reducing water scarcity, reinventing the future of cities and homes, connecting communities to data infrastructure, and expanding access to health and wellness with advanced materials. The business groups include Precision Agriculture, Building and Infrastructure, Fluor, Polymer Solutions, and Data Communications, which collectively pursue human centric solutions to global challenges. A global leader in specialty products and innovative solutions across multiple sectors of industry and commerce, from agriculture and infrastructure to telecommunications, healthcare and more, Orbia has commercial activities in more than 100 countries and operations in 41, with global headquarters in Mexico City, Boston, Amsterdam, and Tel Aviv.

^{1 https://www.epa.gov/sites/production/files/2016-12/documents/transitioning_to_low-gwp_alternatives_in_aerosols.pdf
2 https://www.zephex.co.uk/wp-content/uploads/2019/05/inh_20171201_0036.pdf}

SOURCE Koura