ORLANDO, Fla., Nov. 30, 2017 /PRNewswire/ -- Immune Therapeutics, Inc. (OTCQB: IMUN), a biopharmaceutical company engagedin the development and commercialization of specialty pharmaceutical and biotechnology products to alleviate human suffering in HIV/AIDS, cancer, pain, opportunistic infections and autoimmune and inflammatory disease areas today provided the following
We have had a lot of developments since our last Shareholder update. We know many of you have been asking for updates and we are excited to share the most recent news. We apologize for being relatively quiet this past year, but we will now make it a priority to have consistent updates for our shareholders.
We know results will speak for themselves and we have certainly had our challenges, but I am extremely excited and optimistic about our future. Creating and developing the assets that we currently have has taken a considerable amount of time, dedication, effort and a "never give-up" attitude. With many pieces of the puzzle now together, I believe that we are poised to embark on a journey that will transform Immune Therapeutics and propel us to success.
We are laying the foundation to support a company that we believe has the potential to generate significant revenues, profits, shareholder value, and most importantly a healthy future generation world wide. In both the specialty pharmaceutical and biotechnology areas, we have a platform technology with a clear business model in place to optimize success. In order to achieve this success, we are now in the process of bringing in an experienced management team. We have significant intellectual property, and very large potential markets for our product candidates.
The lack of revenue from Nigeria after obtaining approval has been major concern to shareholders and also to the company. The company's distribution agreement is being modified which caused a delay in shipping product and realization of revenue. The company, in conjunction with AHAR, is working on parallel paths; amending our existing agreement while continuing to explore a possible partnership with Fidson HealthCare Ltd.
The Company and Dr. Afonja from AHAR Pharma and Dr. Gloria Herndon from GB Pharma met with Fidson HealthCare in the United States in October of 2017 where a distribution agreement with Fidson HealthCare Ltd has been signed but not finalized. We are in the process of finalizing the final terms and conditions and hope to have them completed by the first of the year and will meet at that time. It is important to understand that any change in distributors in Nigeria requires the approval of AHAR as they with the Company and Dr. Herndon were responsible for the trials and approval of Lodonal by Nigeria.
Where we had approval from NAFDAC that approval did not provide approval for Lodonal with UNAID, USAID, National Agency for the Control of AIDS ("NACA") National and Global Fund the major agencies that fund HIV therapies. The Company and AHAR have moved forward with the application process but that process could not be started until marketing approval was obtained from Nigeria and the company does not know how long the approval process will take.
In September of 2017 IMUN/AHAR filed our application for the approval of Lodonal with NACA. NACA approval would provide the opportunity for purchases of Lodonal for HIV patients through the agency. The NACA regulatory paperwork is now under review and the Company hopes to have approval by Q1 of 2018.
Milestones that are moving us closer to revenue are:
IMUN has signed a distribution agreement contract in August 2017 with Omaera Pharmaceuticals, a company organized under the laws of Kenya under Commercial Register number C66322, Nairobi, Kenya. Once Lodonal has been approved, Omaera will move forward pursuant to its signed agreement that requires a minimum purchase commitment of over one million pills in the first six months, over 3.6 million pills in the second half of the first year, and 14.4 million and 28.8 million in the second and third years, respectively.
Dr. J. Njoroge, Managing Director of Omaera Pharmaceuticals, Ltd., was quoted in an April press release as saying "Following the finalization of the distribution agreement with Immune Therapeutics, we have made the commercial commitment to launch Lodonal into Kenya and start exploring its medical potential for those suffering from HIV/AIDS, cancer, and other ailments that could benefit from Lodonal." The Company is awaiting an update of the approval from the Pharmacy and Poison Board and will keep shareholders posted as to the status.
The Company has a signed MOU and letter of appointment with Rougier Pharma Afrique, SA in Cote d'Ivoire. As part of the appointment of Rougier, they are working with the local regulatory authority on the approval of Lodonal for the treatment of HIV/AIDS, Cancer and as an Immune Booster. The Company hopes to have approval for Lodonal in Cote d'Ivoire early next year.
Our strategic objectives for 2018
Our Biotech objectives for 2018
Increasing Shareholder Value
After completing additional financing the company will be able to make progress on its objectives. The company intends to take the necessary steps to be in a position to list its common stock on a national stock exchange such as the NYSE, Amex or NASDAQ. An up listing could lead to an increase in shareholder value, give Immune more market exposure, increase liquidity, facilitate partnering activities, and increase our shareholder base to include more fundamental health care investors.
I would like to thank all of our shareholders for their continued support and patience. Management is motivated to make the Immune Therapeutics shareholders financially rewarded and enthusiastic to be a part of the company. The company will make a conscious effort to communicate with shareholders monthly.
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.
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SOURCE Immune Therapeutics, Inc.
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