ORLANDO, FL / ACCESSWIRE / March 8, 2017 / Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage pharmaceutical company developing novel, non-toxic affordable therapies to treat immuno-inflammatory diseases and cancer in emerging markets, today announced that it has signed a Memorandum of Understanding (“MOU”) for distribution of its patented Lodonalâ„˘ in Kenya.
The MOU is a three-way distribution agreement between the Company, its local partner Nairobi, Kenya-based Omaera Pharmaceuticals Limited, a leading Kenyan pharmaceutical importer and distributor, and GB Pharma Holdings, which works closely with IMUN to bring Lodonal to market in West and Central Africa. The MOU sets forth standard terms and conditions for distributing Lodonal in Kenya.
With a population of 47 million, Kenya has 1.5 million people, or 5.9%, of its population living with HIV/AIDS. Its nominal GDP is $152 billion, making it the ninth largest of 53 African countries with a growth rate estimated at 6%. English is one of its two official languages.
Commercializing Lodonal in Kenya
There are three steps remaining to commercialize Lodonal in Kenya. First, is for regulators in the Dominican Republic, where the Company formulates and manufactures its Lodonal, to issue it a Certificate of Pharmaceutical Product (“COPP”) authorizing it to export Lodonal to Kenya.
Second, is for the Company to submit a New Drug Application (“NDA”) to Kenyan regulators and for that to be accepted – by which Lodonal then becomes a “registered” drug and receives a registration number (This is also known as the Marketing Authorization). A full Lodonal preclinical and clinical study program, including four clinical efficacy trials with more than 500 HIV/AIDS, 89 patients for cancer, and 250 patients for autoimmune disease, supports the NDA filing. In recent Phase 3 clinical studies, patient outcomes exceeded end-points by a substantial margin.
Third, will be for the Kenyan Ministry of Health, and/or any of several global healthcare funding agencies, to issue a purchase order of Lodonal for indigenous patients with HIV/AIDS. At that time, Immune Therapeutics, GB Pharma, and Omaera will finalize an exclusive, definitive agreement based on the volume and pricing of those purchase orders and commence sales, marketing, and distribution.
The Company plans to reach commercialization for Lodonal in Kenya in 2017. It is following the same strategy in Nigeria, where the process is further ahead, having already received the COPP, and is anticipated to reach commercialization by mid-2017.
Commenting on the MOU, Noreen Griffin, Chief Executive Officer of Immune Therapeutics, said, “Our new potential distribution agreements for the Kenyan market demonstrate our commitment to bringing Lodonal to patients in Africa today and other emerging markets tomorrow. The world’s patients are in need of drug therapies that are less expensive and less toxic for the treatment of immunologically compromised disease states. Omaera, in conjunction with GB Holdings, are set to be our local distribution partners with the experience, expertise, and commitment to help successfully commercialize Lodonal in their markets.”
Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings, said, “This is yet another successful milestone as we accelerate our progress towards vast approval and distribution of LodonalTM throughout Africa. We are excited to work with the highly regarded Omaera, founded in 1993, and who we know to be an excellent local partner.”
Omaera Managing Director, Dr. J. Njoroge Keige, said, “We are very proud to be part of an initiative that brings innovative and effective immune therapy to those in need in Kenya. This partnership fits within our mission and vision of having both local and regional impact in the pharmaceutical sector.”
About Omaera Pharmaceuticals Limited
Omaera provides quality health care products and, with the current management, has grown to be recognized as one of the most respected distributors and suppliers of pharmaceuticals, surgical equipment, OTC products, and medical equipment in East Africa by both the health care community and the families that entrust them with servicing their healthcare needs.
Lodonal acts as immune-modulator and, in FDA compliant human clinical trials, has been shown to be an effective treatment for HIV and compromised immune systems.
Antiretroviral therapy has been a spectacular success. People are now asking if the end of AIDS is possible. For those who are motivated to take therapy and who have access to lifelong treatment, AIDS-related illnesses are no longer the primary threat, but a new set of HIV-associated complications have emerged, resulting in a novel chronic disease that for many will span several decades of life. Antiretroviral therapy does not fully restore immune health; as a consequence, a number of inflammation-associated and/or immunodeficiency complications, such as opportunistic infections, cardiovascular disease, and cancer, are increasing in importance.
For reasons that remain unknown, antiretroviral-treated HIV disease is associated with a new constellation of problems, generally referred to as “non-AIDS morbidity” and, in the popular press, as “premature aging.” Lodonal can help stop premature aging and non-AIDS morbidity by offsetting the toxic side effects of long-term antiretroviral and autoimmune suppressive therapies. In clinical trials, the Company’s immunotherapy (“Lodonal”) has been shown to stimulate and/or rebalance immune system.
Stimulating and rebalancing the immune system increases the production of DC cells, Macrophages, CD4+T Cells (CD4), CD8+T cells, NK cells, NKT cells, and Gammadelta T cells. Lodonal also inhibits T-reg cells to allow the body to recognize and kill cancer cells, control infection with various microbial agents, and shift T1 to T2 to help control the inflammation and destruction of normal tissues by autoimmune diseases.
About the Company
Immune Therapeutics is a clinical stage pharmaceutical company working to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system using its patented immune-therapies.
Its focus is to sponsor FDA-compliant human clinical research, secure regulatory approval, and commence distribution of such therapies in emerging nations, primarily Africa and secondarily in China. Its patented products and immunotherapeutic technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory and autoimmune diseases. As of December 31, 2016, the growing Immune Therapeutics intellectual property portfolio held 46 pending or approved patents, or exclusive licenses, on its immune-modulating platform, with more actively planned.
The Company’s proprietary technology, therapies, and patents include the treatment of a wide range of cancers. Its most advanced clinical programs involve immunotherapy with met-enkephalin (MENK) (sometimes referred to as opioid growth factor) and its Low Dose Naltrexone product (LDN), or LodonalTM, both of which have been shown to stimulate the immune system even in patients with advanced cancer.
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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SOURCE: Immune Therapeutics, Inc.
Source: Accesswire IA (March 8, 2017 – 12:51 PM EST)