Immune Therapeutics, a clinical-stage biopharmaceutical company developing therapies for a range of conditions using Lodonal, its proprietary formulation of lower-dose naltrexone, has 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, chief executive officer of Immune Therapeutics, “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 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 Ms. 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 given 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 recently announced distribution agreement.  As previously announced, the Company expects to reach commercialization for its patented Lodonal therapy in the current year.

On March 7, 2017, Immune Therapeutics announced that it has signed a Memorandum of Understanding (MOU) for the distribution of 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 is working closely with Immune Therapeutics to introduce and market Lodonal to market in Western and Central regions of Africa. The MOU sets forth standard terms and conditions for distributing Lodonal in Kenya.

Initial orders for Lodonal are expected to be generated from the 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 prior to commencing sales, marketing, and distribution.