The Structural Attractiveness of our Therapeutics, Vaccines, and Platform Technology
TX
o MRSA therapeutic is increasing in importance and economic impact. The market is going to grow from $4 billion to over $7 billion in the next 15 years. The number of clinical trials is increasing, but antibiotics are not as attractive for international pharmaceutical companies as treatments for cancer and metabolic disorders. Our drug has received favorable reviews from Duke and Vanderbilt Medical Schools. We’re about to get another data set. This same formulation may work on other important indications. [High demand, moderate rivalry, little price sensitivity. Outlook for AKAGERA Medicines to achieve our goal is bright.]
o TB/MDR therapeutic is another unattractive business proposition. There are many people who suffer and die from this, and it has a negative impact on whole nations and their economies. Multinational corporations decline to focus on it because the science is hard, and the sufferers are poor. We are commencing our First-in-Human trial presently, and the outlook is positive. Our total product profile (TPP) is that it will be low cost, work with HIV treatments, offer a short duration of treatment, low toxicity, and high efficacy. We are optimistic about a good solution, though even with our novel protocol and possible positive signals next year, the trial will be long and costly. [High demand in poor countries, low purchasing power; low demand in high income nations, many technological hurdles, and complicated biology. Outlook for AKAGERA Medicines to achieve our goal is bright.][1]
o NTMs (nontuberculous mycobacteria) infections are significantly increasing in the USA and around the world. Studies report a rise in prevalence of NTM lung disease at an average annual rate of around 7.5% in the United States, most notably in older populations. And NTMs are increasing in the major urban environments of Africa and are particularly deadly to those who also suffer from HIV. [High demand, low rivalry, price sensitivity by segment, few technological barriers for us, could be quick through trials. Outlook for AKAGERA Medicines to achieve our goal is bright.]
VAX
o Lassa Fever is thought to have only 400,000 sufferers. It’s a rat born disease that is particularly harmful to pregnant women in West Africa. The virus resides in the soft placenta tissue and kills both the mother and the child. Some suggest that the hemorrhagic disease is underreported and may have as many as 4 million sufferers in nations with populations that total as much as 340 million, and all the way across the continent to Kenya. The virus could become a pandemic if it ever became contagious from person to person. However, these are not jurisdictions with insurance coverage, the disease is hard to diagnose, and the purchasing power of the average sufferer is low. Technically, this is not a hard medical problem to solve as antigens are established, but it’s an unattractive industry structure, and so large Pharma has declined to focus on it. We are optimistic about solving this problem. The NIH is supporting us. And we may be able to enter First-in-Human trials in the next 12 to 18 months. [Few technological hurdles and low rivalry, but low demand and low purchasing power. Outlook for AKAGERA Medicines to achieve our goal is bright.]
o HIV has killed 42 million people and continues to kill nearly 1,000,000 people every year. It’s the leading cause of death in some African countries. The world was promised an HIV vaccine as early as 1984. Thirty-eight million people had HIV/AIDS in 2020. The biology of this disease is challenging and requires a different paradigm. Some of our pre-clinical results give us reasons to be optimistic. We’re going to work both on broadly neutralizing antibodies using stabilized cell surface antigens and a T cell response. Our partners include the leading academics in the world and the NIH. This is perhaps the biggest test for AKAGERA Medicines. We accept the challenge because it requires technological innovation, most MNCs have given up, and the disease proliferates in our neighborhood, east and southern Africa. [High demand, low rivalry, many technological hurdles, and complicated biology. Outlook for AKAGERA Medicines to achieve our goal is mixed.]
o TB VAX treatment Market Size was valued at USD 63.11 billion in 2023. The Global Tuberculosis Vaccine Treatment industry is projected to grow to USD 88.28 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 4.38%. There is increasing awareness about vaccination, growing government funding for programs and increased prevalence of infectious diseases that are driving this market. Improved healthcare infrastructure around the world and emphasis on disease prevention are also factors. Price sensitivity will remain high in poor countries, but travelers, expatriates and aid workers will show less price sensitivity when they are moving from a higher income nation to a low-income nation. We anticipate receiving significant grant support to take our TB vaccine into trials in Africa and throughout the world soon. [High demand throughout the world, price sensitivity will vary, some technological hurdles. Outlook for AKAGERA Medicines to achieve our goal is very bright.]
o RSV vaccine market size is $1.3 billion in 2023, over 2 billion in 2024, and could be as much as $3.8 billion by 2034. The space has become crowded with those focused on high income countries and the elderly (>60 years). The market must be carefully segmented. Our vaccine may find its greatest utility in the maternal and pediatric segments. The pre-clinical results are positive. Key Opinion Leaders are encouraging us given that 95% of the cases and 97% of the deaths are in LMICs that are not being served. We are in a unique position to address this access challenge. This is about micro segmentation and focus. [High demand, growing rivalry, correlates of protection are known, so there are not so many technological hurdles. Could be fast to market. Outlook for AKAGERA Medicines to achieve our goal is mixed.]
o Flu VAX market in 2023 is over $7 billion. It’s expected to grow to $18 billion in the next 10 years. Increased government programs, improved vaccines, the rising prevalence of seasonal outbreaks are driving the market. The market is segmented by distribution channel. Nasal spray products will be increasingly attractive. Five multinationals control 80% of the market. The only way to penetrate is through innovation that borders on disruption. Our formulation based on our multivalent delivery system could be that innovation. We have attracted the attention of major funders. [High demand, high rivalry, few technological barriers for us. Outlook for AKAGERA Medicines to achieve our goal is bright.]
Platform
o LNP Platform is its own thing. The global market is projected to reach $3.3 billion with a CAGR of 14.2% over the next 10 years. We recently received data in the relevant animal model that we can provide as many as eight mRNA molecules that are efficacious against flu. This is twice the amount that global pharmaceutical companies are touting, but their formulations suffer from spurious data sets, and high toxicity. Our focus is not yet to make it into a product offering, but to use it in concert with mRNA formulations for a particularly powerful bundled product. May be significant in new formulations against cancer and other diseases. Moderna puts the market valuation of a quatre-valent formulation at $8 billion. [Moderate rivalry, high demand, no significant technological barriers for us. Outlook for AKAGERA Medicines to achieve our goal is very bright!]
[1] https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2024