Morrisville, NC (March 31, 2025): Aerogen Pharma, an emerging leader in the development of novel aerosol therapies to treat life threatening respiratory disease in preterm babies worldwide, announces the cornerstone laying ceremony for the new GenMar Pharma GmbH lung surfactant manufacturing facility in Buchloe , Germany which took place on March 26, 2025. This new facility will manufacture SFRI1 drug substance for Alveofact®, a surfactant marketed by Lyomark GmbH outside the United States, and the surfactant for Aerogen Pharma’s new drug/device combination product which is currently in development. Construction on the new manufacturing facility is due to be completed in December 2025.
Brian Noga, CEO of Aerogen Pharma, expressed his appreciation for the partnerships with GenMar GmbH, Lyomark GmbH, and Vion Foods. “GenMar GmbH and Lyomark GmbH have been strong partners in our quest to develop a superior surfactant treatment solution for preterm infants. We also appreciate and recognize Vion Foods for their strong collaboration as a raw material drug substance provider. Working together, we aim to improve the treatment of respiratory distress syndrome in preterm infants worldwide.”
About Respiratory Distress Syndrome (RDS)
Respiratory distress syndrome (RDS) is a serious breathing disorder affecting 1.4 million infants annually worldwide. RDS is caused by a lack of pulmonary surfactant that helps keep the lungs inflated. The standard treatments for RDS include continuous positive airway pressure (CPAP) to help inflate the lungs, surfactant replacement, and (in the most severe cases) mechanical ventilation where a machine (ventilator) controls the baby's breathing. Typically, surfactant replacement involves placing a tube through the baby's mouth, past the vocal cords, and into the trachea (windpipe), then pouring liquid surfactant into the lungs through this tube. The procedure is technically challenging, is associated with some risks including trauma to the fragile upper airway tissues and decreased oxygenation, and is extremely uncomfortable for the baby unless done under anesthesia.
For more than 20 years, intubation for surfactant replacement therapy has been the standard RDS treatment.
Aerogen Pharma is developing a non-invasive technology that may significantly reduce the need for intubation and associated risks and complications. Aerogen’s investigational product will deliver an aerosolized surfactant mist that newborns can breathe in through their nose while remaining with their parents in the NICU. Aerogen Pharma’s parent company is Aerogen, a leader in acute care aerosol drug delivery.
For more information about Lyomark Pharma GmbH, visit their website at www.Lyomark.com.
About Aerogen Pharma
Headquartered in Galway, Ireland with US development subsidiaries in Morrisville, NC and San Mateo, CA , Aerogen Pharma develops aerosol therapies for life-threatening respiratory diseases in preterm babies worldwide. Aerogen Pharma has extensive experience in respiratory drug development, new drug commercialization, and neonatology. Aerogen Pharma is a business unit of Aerogen Ltd.
About Aerogen
Headquartered in Galway, Aerogen is the world leader in acute care aerosol drug delivery. With a global team of over 600 employees, the company has offices in the US, China, Germany, UAE, and India. Since opening a regional office in Chicago in 2015, Aerogen has expanded its North America team significantly. With over 25 years of experience, 300 international patents, and 200+ peer-reviewed clinical papers and publications related to Aerogen technology, Aerogen technology has been used to treat 25 million patients in 75 countries. Based on a pioneering vibrating mesh technology, the Aerogen Solo has become the gold standard for respiratory patient care across hospitals from the emergency department to intensive care.
To know more about Aerogen, please visit: https://www.aerogen.com/
