Formulation Services

Analytical Services

Company Overview 

News & Media

Join Our Team

3 min read

Alcami Helps Secure FDA Approval for MDGH

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis).

Alcami was honored to have helped MDGH navigate the complex road of bringing an innovative drug to market for the treatment of a neglected disease by utilizing Alcami’s advanced analytical testing services and regulatory compliance expertise to meet critical approval deadlines. This breakthrough program will impact millions worldwide and has the potential to eliminate river blindness.

“FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting,” said MDGH Founder and Managing Director, Mark Sullivan. “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 Organisation Special Programme 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.

ABOUT RIVER BLINDNESS
River blindness is caused by the parasitic worm Onchocerca volvulus, which is transmitted from person to person by black flies that breed in fast flowing rivers in sub-Saharan Africa, Yemen and small foci in South and Central America. The association of rivers and streams, together with the worst manifestation of O. volvulus infection, blindness, led to the adoption of the more commonly known term for the disease, “river blindness.” The millions of larvae (microfilariae) released by the infecting adult parasites invade skin and eyes where they can cause severe manifestations, including permanent blindness, itching and disfiguring skin conditions. Nearly 200 million people are at risk for river blindness, and more than 99 percent of people infected live in sub-Saharan Africa. Chemotherapy with ivermectin (Mectizan®, donated by Merck, known as MSD outside the United States and Canada), previously the only drug approved by the FDA for onchocerciasis, is the current standard approach to onchocerciasis control and elimination. Ivermectin has significantly reduced the disease burden, but new treatment options are needed to accelerate progress toward eliminating parasite transmission.

ABOUT MOXIDECTIN
Moxidectin is a macrocyclic lactone anthelmintic medicine that selectively binds to the parasite's glutamate-gated chloride ion channels. These channels are vital to the function of invertebrate nerve and muscle cells. Moxidectin has activity against O. volvulus microfilariae but does not kill adult O. volvulus parasites.

Please see full Prescribing Information, available at Drugs@FDA.

ABOUT MDGH
Medicines Development for Global Health is a biopharmaceutical company headquartered in Melbourne, Australia. Established in 2005, this unique organization is dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH is a not-for-profit, social enterprise. For more information, please visit medicinesdevelopment.com.

REFERENCES
1. Full Prescribing Information: Drugs@FDA.

CONTACT MDGH
Ranya Alkadamani
Founder and CEO
Impact Group International
+61 434 664 589
ranya@impactgroupinternational.com