Lodonal™ Trial Update: Nigeria
IORLANDO, Fla., Feb. 20, 2018 (GLOBE NEWSWIRE) — via OTC PR WIRE–
Immune Therapeutics, Inc. (OTCQB:IMUN) (“Immune” “IMUN” or the “Company”), a clinical late stage biopharmaceutical company focused on the development of two immunomodulating therapies (IRT-103 “Lodonal” and IRT-101 “MENK”) for the treatment of autoimmune diseases, inflammatory diseases, cancer and HIV/AIDs, today announced the company has shipped its initial order of Lodonal to AHAR Pharma in Nigeria.
In addition, IMUN has received both trademark and patent approval from the Federal Republic of Nigeria giving the Company ironclad protection of its ideas, inventions, designs, and trade secrets while also ensuring IMUN legal rights are not infringed upon.
Immune Therapeutics shipped 100,000 capsules of Lodonal fulfilling the initial purchase order for $195,000 with AHAR Pharma, Immune’s agent and distributor in Nigeria. Since the company’s shipment has recently cleared customs, it is now available via AHAR in Nigeria.
The company has received a Certificate of Patent Approval for Lodonal NG/P/2017/602 and Certificate of Registration of Design (Trademark, Name, Box Design) NG/D.2017/603.
CEO Noreen Griffin states, “The initial Lodonal order to Nigeria is just the beginning for us with many more to come based on our strong relationship with AHAR and our ability to expand our reach in the African country through a number of potential sub-distributors for sales and marketing.” “While we are focused on an aggressive marketing strategy of Lodonal in Nigeria it is vital for us to register and protect our intellectual property rights there as well especially due to the fact that we are a non-Nigerian business desiring to take a slice of the almost 200 Million strong import-dependent domestic market which Nigeria represents. We also believe it forestalls potential pirating and counterfeiting of our products as well.”
“Immune and AHAR are currently completing the necessary regulatory paperwork for presentation to the National Agency for Food and Drug Administration and Control (NAFDAC) for the approval of Lodonal for a number of additional indications.”
Griffin said she believes the company will be ready to submit to NAFDAC in Q1 of 2018.
The company plans to meet this month with AHAR, GB Pharma and Fidson HealthCare as a follow up to their initial meeting in October, 2017. The companies plan to further discuss the potential for the transfer of distributorship from AHAR to Fidson. Under a potential new agreement, AHAR would remain Immune’s agent in Nigeria.
About Immune Therapeutics, Inc.
Immune Therapeutics Inc., is a late stage, Biotechnology Company focused on the development and commercialization of our highly innovative immunotherapies for the treatment the treatment of HIV/AID’s, cancer and autoimmune and inflammatory disease. Our proprietary and patented therapies combat these diseases by activating and/or rebalancing the immune system.
IMUN’s drug discovery are based on two interrelated immunotherapies that are patented, licensed to the Company and our lead candidate Lodonal is a repurposed drug.
Lodonal has demonstrated success versus other drug platforms having already achieved strong validation with regulatory drug approval in Nigeria and Dominican Republic. The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health of Nigeria granted drug and marketing approval as a immune system regulator in the management of HIV patients. The Directorate General of Drugs & Pharmaceuticals, under the Ministry of Public Health in the Dominican Republic approved Lodonal for the treatment of HIV/AID’s, Cancer and other immune dysfunction. The Company believes that these approvals will allow us to shortly begin commercialization in these countries. In addition IMUN has filed for New Drug Approval in Kenya, Senegal and Haiti and hopes to have approval by the end of 2017 in at least one of these countries.
While traditional drug development targets each drug to a particular disease, such as drug A for disease A, drug B for disease B, etc., we are approaching the process by identifying and targeting survival or activation immunology pathways that cross over between different diseases. Our lead product Lodonal shows the success of this model.
This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company’s filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company’s filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.