IMUN 0.015 ORLANDO, Fla., Nov. 30, 2017 /PRNewswire/ -- Immune Therapeutics, Inc. (IMUN), a biopharmaceutical company engaged in 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 letter to shareholders:
Dear Shareholder:
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.
Nigeria
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:
AHAR Pharma moving forward with a soft launch for Lodonal in Nigeria and issues an initial purchase order for $195,000.00 with an initial deposit paid November 22, 2017.
AHAR is negotiating with four sub-distributors for the sales and marketing of Lodonal in Nigeria. They anticipate signing up two of them before the end of 2017.
AHAR's marketing program includes the launch of a new website, www.aharpharma.com. The site will allow online doctor visits and online ordering of Lodonal™ directly from AHAR through its virtual doctor program
AHAR and IMUN are in the process of filing New Drug Applications with NAFDAC for additional indications with Lodonal for Cancer, Adjunct to Cancer Treatment, Chronic Pain, and Opportunistic Infections.
AHAR and IMUN are working with NAFDAC to obtain Over the Counter Approval for Lodonal
A letter of Intent has been signed with ImperiaStone, Ltd., a Nigerian company, for the distribution of Lodonal in Nigeria. ImperiaStone's team is comprised of very experienced professionals with diverse backgrounds in various business sectors including commodities, energy, and infrastructure. They are committed to contributing towards the diversification of the Nigerian economy through their activities and partnerships with world-class organizations. ImperiaStone plans to expand their operations into the pharmaceutical sector. This relationship will allow IMUN to begin to work with a number of large organizations especially in the mining sector where healthcare of employees is a major commitment.
Kenya
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.
AI
