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Nigeria tests new immune-boosting drug from U.S. for HIV, cancer, others

By Chukwuma Muanya   |   02 September 2015   |   11:42 pm  

Herndon

Herndon

GB Pharma in partnership with Immune Therapeutics Incorporation and American Hospitals and Resort (AHAR) have signed Letter Of Intent (LOI) with one of Nigeria’s leading pharmaceutical companies, Fidson Healthcare Plc, for the distribution of an immune boosting drug, Lodonal.

Founder, President and Chief Executive Officer (CEO) of GB Group Global, Dr. Gloria Bozeman Herndon, in an exclusive interview with The Guardian said
GB Pharma and its partner organizations, Immune Therapeutics and AHAR Pharma have engaged in and are funding a 90-day bridging clinical trial for its proprietary patented therapy, Lodonal, as an adjunct treatment for Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) and opportunistic infections in the State Specialist Hospital, HIV Clinic, Asubiaro, Osogbo, Osun State.

GB Group Global consists of GB Energie, GB Energie LED, GB Pharma Holdings and GB Oncology & Imaging Group. The GB Group currently focuses on innovative and sustainable solutions in the energy, environment and health sectors.

Herndon said collaborators include Principal Investigator and Lead Consultant is Dr. Abayomi Akinwale Oni and Principal Investigator Dr. Richards Afonja of AHAR. She said the purpose of the bridging study is to evaluate the effects of Lodonal as an Immune-System Regulating Agent in subjects in which their immune system is compromised. The Osun State Ministry of Health Ethics Committee, Asubiaro, Osogbo are overseeing the trial. The primary objective of this clinical trial is to confirm that Lodonal has a beneficial effect on the immune system of patients in Nigeria who have a compromised immune system.

Herndon said an agreement between Immune Therapeutics GB Pharma/AHAR with Fidson Healthcare will enable Fidson marketing, sales, customer support, and technical assistance organization to promote Lodonal in Nigeria. This, she said, will elevate Immune Therapeutics and GB Pharma/AHAR distribution network to the next level. The distribution will become effective, upon completion of the ongoing National Agency for Food Drug Administration and Control (NAFDAC) approved 90-day Bridging trial evaluating the efficacy and safety of Lodonal.

Lodonal ‘s chemical name, Naltrexone, is an opioid antagonist used primarily in the management of alcohol and opioid dependence; the United State Food and Drug Administration (FDA) approved Naltrexone in 1984 at 50mg.

However, accumulating evidence suggests in its low dose form (LDN, 4.5mg) can promote health supporting immune modulation, which reduces various oncogenic inflammatory autoimmune processes and immune compromised states such as in HIV and non-HIV states.

Dr. Ian Zagon at the University of Pennsylvania recognized the value of LDN as an immune modulator. The late Dr. Bernard Bihari, a Neurophysician from New York, who passed away on May 16, 2010, began treating his HIV/AIDS patients in the late 1980s. Since that time, many doctors throughout the United States prescribe LDN for a number of indications including Multiple Sclerosis (MS), Parkinson’s disease, Crohn’s disease, HIV/AIDS, cancer and other autoimmune and inflammatory diseases.
W
ith the total population in Africa of 1.111 billion (2013) and the incidence and prevalence of HIV and other non-HIV immune compromised states, Lodonal, being affordable, well tolerated and efficacious in boosting the immune status of individuals at risk is novel and revolutionary. At this time there’s no cure for HIV/AIDS, but there are medications that can dramatically slow disease progression. These drugs have reduced AIDS deaths in many developed nations. However, HIV/AIDS continues to decimate populations worldwide. It is such a devastating health challenge that the US Department of State through its United States Presidential Emergency Preparedness Fund for AIDS Relief (PEPFAR) provides emergency assistance for more than 21 partners, one of which is Nigeria.

We believe LDN could be an answer; LDN is safe, easy to administer and affordable. Through the bridging trial, Nigeria has once again assumed its leadership position by undertaking a bridging trial that will allow Lodonal to be available to its population and ultimately the rest of Africa. This will revolutionize the concept of health security in Africa by providing an immune booster that offers solutions that are non evasive and reactive and whereby early deaths due to opportunistic infections would be reduced, thus increasing the labor force essential for the world’s fastest growing continent.

CEO/Managing Director of Fidson, Dr. Fidelis Ayebae, said: “Fidson is truly excited about this collaboration with Immune Therapeutics and GB Pharma/AHAR. We know that success in this industry going into the future will be dependent on having the right partnerships, and we could not have asked for better partners at this stage of our growth. Immune Therapeutics and GB Pharma/AHAR international experience in different markets and their strong commitment to research will be of immense benefit to Fidson. Likewise, Fidson’s towering presence in the Nigeria Pharma space will open a great door for the group to access one of the biggest and most rewarding markets in Africa.”

Fidson Healthcare Plc recorded sales of USD60.5 million in 2014 and has seen revenues rise at a 15 per cent Compound Annual Growth Rate (CAGR) over the last five years. Its consistent performance in the Nigerian pharmaceutical sector was recently recognized by Frost & Sullivan, who named Fidson as the recipient of its ‘2014 Growth Excellence Leadership Award in the Nigerian Pharmaceutical Industry’. The Company has also won other corporate awards including the Financial Standard ‘Pharmaceutical Sector Leader’ Award in 2008 and the ‘Nigerian Pharmaceutical Company of the Year’ at the Nigerian Healthcare Excellence Awards (NHEA) in 2014. Fidson’s definitive growth and consistent performance in the Nigerian stock market also earned her CEO the 2014 BusinessDay Top 25 CEOs Award, which the company has won consecutively for two years.

To offer options in manufacturing Fidson will be commissioning a USD54.0 million manufacturing plant in the fourth quarter of 2015. The new facilities will double the company’s production capacity. The new factory will also for the first time, add intravenous fluids to Fid son’s product portfolio. The facility is built to conform to the World Health Organization (Geneva) current Good Manufacturing Practice (WHO-GMP) standards.

Herndon is a native of East St Louis, Illinois, United States. She attended Southern Illinois University and graduated magna cum laude with Bachelor degrees in Political Science, Philosophy and Music. Herndon continued on to Johns Hopkins University where she received a Masters Degree in International Economics and Law. She was later accepted into the doctoral programme at Johns Hopkins University where she attained additional academic success as a Rockefeller Fellow. Notably, Herndon also received an honorary mention for the Woodrow Wilson Fellowship. While pursuing her doctorate, Herndon also worked as a research fellow at the Brookings Institute and was a member of the Council on Foreign Relations at the Carnegie Endowment for International Peace.

While completing her doctoral course work, Herndon accepted a position as an economist with the U.S. Department of Agriculture’s Foreign Agricultural Service. A year after joining the USDA, she was accepted into the Foreign Service of the U.S. Department of State. Posting as an economic/commercial officer in Lagos, Kaduna, Kinshasa, Monrovia and Nouakchott. Along with her regular duties, she sought to further the U.S.-Nigerian trade relationship by strengthening the Nigerian–American Chamber of Commerce. Herndon spearheaded initial delegation to the U.S. from Lagos and repeated this success by leading the Kaduna Chamber’s first delegation to the United States as well. While in Nigeria, Herndon wrote her dissertation and taught undergraduate economics courses at Ahmadu Bello University (ABU) Zaria. She received her doctorate in Economics and International Law from Johns Hopkins University.

Herndon has also joined Former United States (US) Ambassador to Nigeria, Dr. Robin Renee Sanders, to commiserate with the people of Nigeria on the death of the country’s Ambassador to US, Prof. Adebowale Ibidapo Adefule.

Herndon told The Guardian: “I really want to extend my condolences on the death of Ambassador Adebowale Ibidapo Adefuye who was a kind, gentle man and he really stood up for Nigeria in the United States. He was a friend to the diaspora, a friend to women, a friend to professionals, a friend to our course. We loved him deeply. He was always there, he was active, and he was on time man. He has given the best of his service and we say well done, it is well done. Well-done Prof. Adefuye! You are a great ambassador; you are a great representative of Nigeria and all of the American loved you.”

What brings you to Nigeria? Herndon said: “Now what brings me to Nigeria? This is nostalgia and this is also labour of love. I first came to Nigeria in 1969 right after the Biafra war. I was doing some research on a kind of a book and I met many great people when I came to Nigeria in 69. I came back in 1975 as the first black female Economic Council to the American Embassy in Lagos and I stayed there after and became the first black female officer in the consulate in Kaduna in in 1978. So I have a passion for Nigeria, I have a passion for working with Nigeria and I have the passion of the relationship between the African diaspora and Africa and the need for us to come together and to make sure we are doing excellent, parallel, good core business together as the personification of our reconnection as a result of the former middle passage. I say what we are doing now is the reverse middle passage but this time we paying on our way back and we are going to pave our way back. So I am just happy to be here with you.”

How did you discover this relationship Fidson Healthcare Plc? She said: “So let me tell you how I got to Fidson. I gave you a general background of what my core values are and how I have a history with Nigeria. In the pharmaceutical business as you know, a lot of fake pharmaceuticals have been dumped in Africa. That has not only hurt people, but also have not help them, which also hurts them. They have projected the next year; the pharmaceutical industry in all of Africa will be about $30 billion.

“There is a tremendous need. If people cannot get the right pharmaceuticals in the right help for their health, people will die, so you have to deal with what is important, that is your human resources. So we are here to try to bring innovative, good quality, effective pharmaceuticals to the continent and we are doing it in a very special way. We are working in American providing innovative, the best licenses, the most innovative drugs, the most protected and quality drugs and those drugs if not importing into the country, we are trying to manufacture in the continent.

“Why Fidson? Because Fidson has that same core value, they are ethical, they believe in excellence, they are manufacturing, they are setting up the best WHO ISO manufacturing plant that I have seen not only in Africa but also in the world. So this is a world-class organization, getting ready for world-class condition and coming and meeting the needs and as part of that transition that I have been a part of a long time. I am here to work that out with him because Fidson is the best and this is why we want to work with him.”

What diseases are you partnering with Fidson to tackle and what kinds of drugs you are looking at? Herndon said: “Let me tell you what we are doing right now. As I told you we are going down this part with Fidson but what we have also done, we have tried to pave the way with NAFDAC and the FDA. Now, we are right now undergoing a 90-day bridging trial on HIV on innovative drug that we have in the U.S. called Lodonal (LDN). What is LDN? LDN is an immune booster. What it does is it has several indications; it works with HIV, it works with Crohn’s disease, it works with ailments and other diseases. And what it does is that it builds the immune system so that intending with other applications, other kind of medications or protocols, it assists in building the immune system and the body fights off these diseases.

“I will tell you. It is innovative, it is cognitive and it is something that is going to save a whole lot of lives and do a lot of good. The man who invented this or came up with the patent was Dr. Bernard Bihari. Now that is not to say he is the brother to the President but what he did was he said he wanted these drugs to be available to people who could not ordinarily get it, the people who deserve it the most, the majority of the people who cannot afford to pay $3,000 to $4,000 a month for immune bolsters or agents.

“So he made the commitment that these drugs cannot be sold for more than $1 a pill. So it can be affordable. He died. His wife has made the same commitment. Big Pharma has tried to buy this patent from her for $50 to $60 million but she refused money because she said her husband’s commitment was to get to people who could not afford it, to save lives of the masses. So you know what, she is running down that road with Jesus and Moses helping the masses just like Buhari wants that to happen. So I am part of this whole evangelism too, the fact that we are bringing something to the masses, this is going to enhance their health, enhance their quality of life, enhance the length of their lives, and ultimately enhance production, enhance development and do all the good God work that we need to do on this Earth.”

What is the level of partnership between GB Pharma and Fidson? She said: “Look, what we are doing is we are bringing out a pattern that if you say you have a million patients a day, but Fidson will be able to do is initial we’ll import until their facility is up and when their facility is up, then Fidson can manufacture these products. These products will be helping a whole lot of people in Nigeria but we are also promoting inter-African trade so that people from Kenya can import this, people from Ghana can import this and automatically people from Indian can import this and finally, hopefully people from America can import this. So what this is going to do for Fidson? It is going to put them on the world stage like it already is but more prominently by them being able to produce a product that can be used all over the world. You know what that also means? That can not only get some recognition but also you can get some cash flow from India, China, America and the rest of Africa.”

Basically, is it only the Lodonal drugs that you will be producing with Fidson or are there others? Herndon said: “No! We are looking at a whole lot of other drugs. We have one drug that is for cold sores.

Cold sores can be from herpes and other kind of conditions; we want to manufacture that here. We have another, we have the hand sanitizer that can be manufactured, and it is not only good for regular sanitizing but also known to be good for other kind of serious diseases. So we have a bevy of our products that are high biotech, that are excellent products that can be manufactured here with



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