Immune Therapeutics Clears Critical Regulatory Hurdle for Lodonal in Kenya
Immune Therapeutics a clinical-stage biopharmaceutical company developing therapies for a range of conditions using Lodonal, its proprietary formulation of lower-dose naltrexone, announced that the Dominican Republic Ministry of Public Health has granted Immune’s request to export Lodonal to Kenya.
Immune Therapeutics formulates and manufactures Lodonal in the Dominican Republic. Local laws require a Certificate of Pharmaceutical Product (“COPP”) to export Lodonal to Kenya.
“The granting of our export license by the Ministry represents the next critical step in our strategy to initiate future commercialization of Lodonal in Kenya,” stated Noreen Griffin, Immune Therapeutics, Chairman and CEO. “A New Drug application cannot be filed without a valid Certificate of Pharmaceutical Product.”
The Ministry’s approval for Lodonal was granted and registered for the period of five (5) years, under No. 2017-0068, in accordance with Regulation No. 246-06 dated 22 June 2006. Separately, the Ministry of Public Health and Social Assistance Vice-Ministry of Quality Assurance General Directorate of Medicines, Foods and Health Products issued a Certificate of Pharmaceutical Products for Lodonal for export to Kenya.
“With our COPP in place, our next step is to submit a New Drug Application (NDA) to Kenyan regulators along with data from our Lodonal preclinical and clinical study program,” noted Griffin. “Once our application is accepted, we will receive a registration number (marketing authorization). From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. If we are granted fast track status, the approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recent announcement that company has signed a MOU with a local distributor. The Company hopes to reach commercialization for Lodonal in Kenya in 2017.
On March 7, 2017, Immune announced that it has signed a Memorandum of Understanding (“MOU”) for distribution of its patented Lodonal in Kenya. The MOU is a three-way distribution agreement between the Company, its local partner Nairobi, Kenya-based Omaera Pharmaceuticals, Ltd., a leading Kenyan pharmaceutical importer and distributor, and GB Pharma Holdings which works closely with Immune to bring Lodonal to market in West and Central Africa.
Initial orders for Lodonal are most likely to come from Ministry of Health, and/or any of several global healthcare agencies that fund treatment for indigenous patients with HIV/AIDS. At that time, Immune Therapeutics, GB Pharma, and Omaera will finalize its exclusive, definitive agreement based on the volume and pricing of those purchase orders and commence sales, marketing, and distribution.