ORLANDO, Fla., May 31, 2017 (GLOBE NEWSWIRE) — Immune Therapeutics, Inc.(OTCQB:IMUN), a specialty pharmaceutical company focused on developing and commercializing our novel patented, affordable, non-toxic therapy for the management of cancer, HIV, autoimmune diseases, and other inflammatory conditions, today announced that it has signed a Memorandum of Understanding (“MOU”) for the distribution of its patented Lodonal™ in Côte d’Ivoire (the Ivory Coast).
The MOU is between Immune Therapeutics, GB Pharma Holdings and Rougier Pharma Afrique SA and sets forth a framework for the future standard terms and conditions for distributing Lodonal in Côte d’Ivoire. With a population of 27 million, Cote d’Ivoire has the fastest growing economy of the African continent and the third-fastest in the world in 2016, and the African Development Bank (AfDB) projects the country’s GDP to grow at approximately 8.3% in 2017. Côte d’Ivoire has experienced an impressive turnaround since 2011, with economic growth averaging about 9% per year. The economic outlook remains strong and is supported by strategies explained in the ‘National Development Plan (NDP) 2016-20’. The NDP prioritizes inclusive and sustainable growth; focusing on structural transformation and improving quality of life for all Ivorians.
The issuance of a Certificate of Pharmaceutical Product (“COPP”) has granted the Company a license to export Lodonal to Côte d’Ivoire, which has been authorized by the Dominican Republic Ministry of Public Health. Now the Company is ready to submit a New Drug Application (“NDA”) to Directorate of Pharmacy and Medicines. The application will include the following information, COPP, Proof of cGMP, Certificate of Analysis, Dossier, Patient Data Sheet, Packaging and all clinical data supporting the request for approval. Included with the clinical data were the results of four phase II clinical trials and one bridging trial clinical trials HIV/AIDS with more than 500 patients, as well as 89 patients for cancer, 250 patients for autoimmune and inflammation diseases.
The Company plans to position Lodonal within the Pharmacie de la Santé Publique (PSP) as an immune booster and adjunct immune therapy for cancer and HIV/AIDS. The PSP is an integral part of universal healthcare provided by the government as part of its public health policy. With a national prevalence rate of HIV estimated at 3.7%, the impact of the HIV/AIDS pandemic is such that it represents the first cause of death for men and the second for women (the first being problems during pregnancy and childbirth).
Immune Therapeutics, GB Pharma and Rougier expect to finalize an exclusive, definitive agreement within the next 60 to 90 days and should be in a position to provide purchase orders and commence distribution immediately upon approval by Directorate of Pharmacy and Medicines.
The Company anticipates distribution and sales of Lodonal in Côte d’Ivoire by the end of 2017. Rougier is leading the approval process in country with the support of IMUN and GB Pharma. Once drug approval is obtained in Côte d’Ivoire, Rougier intends to expand distribution to Benin, Togo, Burkina Faso, Niger and Gabon after facilitating the approvals in these countries as well.
Commenting on the MOU, Noreen Griffin, Chief Executive Officer of Immune Therapeutics, said, “This is our next step in making Lodonal available to millions of people in Africa and hopefully around the world that suffer from HIV. HIV therapy does not fully restore health. For reasons that remain to be elucidated, antiretroviral-treated HIV disease is now associated with a new constellation of problems, generally referred to as “non-AIDS morbidity”. Lodonal has been shown as an immunomodulator to helping offset the toxic side effects of ART therapy, which will improve the quality of life for HIV/AIDS patients throughout the world.”
Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, said, “This is yet another successful milestone as we accelerate our strategy of providing Lodonal as the first affordable non-toxic therapies throughout Africa. By forming a relationship with Rougier Pharma we again have a top distributor in the region.”
Rougier Managing Director, Mr. Faustin Kouassi, said, “We are very proud to be part of an initiative that brings innovative and effective immune therapy to those in need in Côte d’Ivoire”
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives. There are approximately 37 million people living with HIV/AIDS around the world, with 25.5 million of them living in Africa.
Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. Lodonal blocks the opiate receptors temporarily (typically 2-4 hours) leading to rebound increase in endogenous opioids, endorphins and met (5) enkephalin or OGF involved in regulating immune function & cell proliferation.
Lodonal’s approval as a daily oral Immune System Regulator for the management of HIV/AIDS is based on the results of a 90-Day bridging trial and several Phase II multi-center, randomized studies demonstrating that patients treated with Lodonal reported significant improvements when compared with counterparts receiving placebo.
Trials in Nigeria showed that the drug was able to offset the toxic side effects of the HIV therapy, reduce inflammation and opportunistic infections, making Lodonal possibly the first non-toxic adjunct therapy that improves the life of millions of people taking HIV medication.
About Immune Therapeutics, Inc.
Immune Therapeutics, Inc. (OTCQB:IMUN) is a clinical-stage biopharmaceutical company developing its proprietary version of lower-dose naltrexone, Lodonal™, as a standalone and conjunctive therapy in patients with a wide variety of conditions including HIV/AIDS, autoimmune diseases, cancer, neurodegenerative conditions and other inflammatory conditions. Lodonal is a novel compound with a unique mechanism of action and has clinical data on over 2,000 patients in several clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint.
About GB Pharma Holdings
GB Pharma Holdings is a Washington D.C. global pharmaceutical consulting company with expertise in defining policies, facilitating approvals, distribution and cGMP (current Good Manufacturing Practices) and introducing innovative therapies to Africa. It was established in order to be on the forefront of change and is dedicated to bringing cost effective and quality products to Africa. GB Pharma Holdings is able to link new technologies, science and education together to be a cause for good. Its core focus is twofold; facilitate manufacturing of cGMP quality pharmaceuticals and helping existing government agencies develop testing and regulations to purge counterfeit and sub-potent products out of their respective countries.
About Rougier Pharma Afrique SA
Rougier is a pharmaceutical company that is involved in the manufacturing, distribution, marketing and import and export of pharmaceuticals. It also has presence also in Burkina Faso, Togo, Niger and Gabon. With three primary lines, it is one of the oldest and fastest growing pharmaceutical companies in Côte d’Ivoire.
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 of 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.
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