"Our colleagues at Medicines Development for Global Health have reached a significant milestone," said Syed T. Husain, chief commercial officer, Alcami. "We are very pleased to have helped MDGH navigate the complex road of bringing an innovative drug to market for treatment of a neglected disease. This breakthrough program will impact millions worldwide, and has the potential to eliminate river blindness."
MDGH founder and managing director, Mark Sullivan, said, "FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting. It takes a broad community to develop a new medicine. FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders, and study participants. We operate as a virtual development team, so without the support of our dedicated collaborators such as Alcami, such incredible achievements would not be possible."
Moxidectin is a macrocyclic lactone anthelmintic medicine that selectively binds to a disease-causing parasite's glutamate-gated chloride ion channels, vital to the function of its nerve and muscle cells. The drug has the potential to treat nearly 200 million people at risk of river blindness, 99 percent of whom live in sub-Saharan Africa.
On Wednesday, June 13, 2018, MDGH and its collaborator, the World Health Organization Special Program for Research and Training in Tropical Diseases (TDR), jointly announced moxidectin's FDA approval, and receipt of a priority review voucher (PRV). The PRV entitles MDGH either to faster review of new drug applications (NDA), or it may be sold to further fund research and development.
Alcami and MDGH began their relationship in September 2016, developing and validating a discriminating dissolution method. The project evolved to incorporate analytical support for drug product process improvement, additional analytical support including inductively coupled plasma mass spectrometry (ICP-MS) testing, and a solubility study-all at an accelerated pace-to meet MDGH's NDA filing timelines. The two companies are exploring future opportunities to work together across Alcami's broad service offerings and MDGH's focused efforts to eliminate neglected tropical diseases, which affect over 1 billion of the world's most disadvantaged people.