Critical care company Ikaria, Inc. and biopharmaceutical company Lee’s Pharmaceutical Holdings Limited (Lee’s Pharm) have just signed signed a new agreement to drive the registration and commercial approval of INOMAX® (nitric oxide), a breakthrough inhaled treatment of hypoxic respiratory failure (HRF), in China, Hong Kong, Macau and Taiwan. The drug will be offered as a Total Care Package, which will include a state of the art drug-delivery system, training, and 24/7 technical assistance and support. The financial stipulations of the contract were not reported.
Hypoxic respiratory failure is a life-threatening cardiopulmonary event caused by pulmonary hypertension in newborn infants older than 34 weeks after birth. PH causes the lung vasculature to constrict, significantly reducing oxygenation of the body’s cells, which is very poorly tolerated by neonates. INOMAX®, currently the only US FDA approved treatment for HRF, is inhaled nitric oxide, which works to relax the blood vessels leading to and in the lungs. When administered in conjunction with ventilatory support, INOMAX can significantly improve oxygenation.
Daniel Tasse, the Chief Executive Officer of Ikaria, said it is the company’s top priority to expand to the Asia-Pacific region, as they see potential for growth over the coming years. Their new collaboration with Lee’s Pharm gives them strategic leverage in terms of preexisting infrastructure, expertise in cardiovascular therapies, and experience with regulatory and commercialization issues. Ikaria is determined to bring INOMAX® Total Care to major Asian markets to ensure this novel treatment grows to be remotely available to world populations most in need. Today, INOMAX® is approved in the US, Europe, several countries in South America, Australia, Canada, Japan, and South Korea.
“We are honored to partner with Ikaria to bring INOMAX® to the Greater China areas. As the only FDA-approved pharmaceutical nitric oxide worldwide, the availability of INOMAX® will address a significant unmet medical need in the territories, given the high number of newborns each year,” said Dr. Li Xiaoyi, Executive Director and Chief Executive Officer of Lee’s Pharm. “This opportunity reaffirms our commitment to the critical care area. We will start the registration process in earnest, as to provide patients access to this life-saving treatment as soon as possible.”