Collaborators and licensors can now access the same market-equivalent devices that are fundamental to the development of our own portfolio of inhaled drug/device combination products for critical care.We enable partners to develop cutting-edge inhaled therapies, and may also consider in-licensing the most promising candidates for further development at our own expense.
The Bill & Melinda Gates Foundation
Aerogen Pharma is working in partnership with The Bill & Melinda Gates Foundation (BMGF) to bring the benefits of life saving surfactant therapy to babies born prematurely in Low and Middle-Income Countries (LMICs).
Striving to develop an EFFICIENT, SAFE, FEASIBLE and COST-EFFECTIVE surfactant treatment option for preterm infants in LMICs.
Every year around the world, an estimated 1.4 million neonates develop Respiratory Distress Syndrome (RDS), with two-thirds occurring in low- and middle-income countries (LMICs) where access to intensive care facilities is limited1,2. RDS is the leading cause of death among preterm infants in LMICs, with fatality rates reported to range from 57% to 89%3. Although pulmonary surfactant was added to the WHO Essential Drug List in 2008, access to this gold standard treatment for RDS is limited in LMICs by high drug costs, lack of personnel trained to administer surfactant, and shortage of the sophisticated medical equipment necessary to enable invasive mechanical ventilation and endotracheal instillation. One bright spot is that non-invasive CPAP ventilation is becoming more available in many LMICs as the primary mode of managing RDS4. It is our belief that a surfactant delivered through CPAP ventilation has an important role to play in expanding the benefits of surfactant replacement therapy to a wider population.
As a natural extension of their drive to make CPAP more readily available in the countries where they operate, BMGF has partnered with Aerogen Pharma to develop Efficient, Safe, Feasible and Cost-Effective surfactant treatment for preterm infants in LMICs. Our shared goal is to see fewer families touched by the tragedy of infant mortality, and more preterm babies survive to enjoy full and productive lives.
Joint Program 1
AeroFact™ Proof-of-Concept Clinical Study in South Africa BMGF is supporting Aerogen Pharma in the conduct of a 232-patient clinical trial of our AeroFact™ inhaled surfactant in South Africa. This study began in April 2023 at three major Neonatal Intensive Care Units in Cape Town & Johannesburg. The enrollment of the first patients took place in May 2023Our goal for this study is to demonstrate the safety and efficacy of aerosolized surfactant in the South African clinical and public health environment, since it is unwise to assume that clinical advances can be shifted from a high income setting to a LMIC setting without thoughtful adaptation. For more information on this trial, please see the study entry into the registry of the South African Health Products Regulatory Agency.
Nuance is a clinical-stage biopharma company with a late-stage clinical pipeline and a portfolio of commercialized assets across respiratory, emergency care, iron deficiency anemia and pain management indications. With the mission to address critical unmet needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a leading innovative pipeline, while maintaining a self-sustainable commercial operation in China and Asia. For more information, please visit https://www.nuancepharma.com.