Bleeding Edge

Dr Churchill’s non profit foundation People’s Health International is the only goodwill organization that is exclusively combating the persistent threat of Tuberculosis that is still to this day the number one killer, amongst all infectious diseases in our world. And yet up to now, we have had no cure for the antibiotic resistant form of TB, or for any of the other extreme antibiotic resistant strains of Tuberculosis that ravage humanity. Sadly, we do not even have any successful vaccination against these most virulent strains of TB, nor do we have any potent medicines that we can use to save lives until the open-source effort that we fostered and participated into, and that eventually led to the advent of “Pretomanid” the first new anti-Tuberculosis medicine that was just approved by the FDA, on August 15th of 2019.

This is a major milestone, because Tuberculosis is the leading infectious disease cause of death worldwide. In 2017, 10 million people fell ill from active TB and 1.6 million died. The vector of the disease is such, that in 2018, and in 2019, the numbers are even worse. Tuberculosis is an airborne disease that can be spread by coughing or sneezing. Drug-resistant forms of TB currently account for close to one in three deaths due to antimicrobial resistance annually. The FDA approval of Pretomanid is a “victory for the people suffering from these highly drug-resistant forms of the world’s deadliest infectious disease.” The great hope is that the new treatment regimen, will provide a shorter and more manageable treatment for those patients in need.

Until very recently, people infected with highly drug-resistant TB had rather poor treatment options and a very poor prognosis, whereas this new regimen provides hope with nine out of 10 patients achieving culture negative status at six months post-treatment with this short, all-oral regimen.

Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance acquired the developmental rights to the compound in 2002. It was granted Priority Review, Qualified Infectious Disease Product, and Orphan Drug status. The LPAD pathway that was used for the approval of Pretomanid was established by FDA as a tool to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infections that affect a limited population of patients with unmet needs.

Pretomanid is expected to be available in the United States by the end of this year. In addition to the United States Food & Drug Administration, the TB Alliance has submitted Pretomanid as part of the BPaL regimen for review by the European Medicines Agency (EU-FDA) and has provided data to the World Health Organization for consideration of inclusion in treatment guidelines for highly drug-resistant TB. Today the nonprofit group TB Alliance offers the only FDA approved treatment, because the FDA greenlit “Pretomanid” under the “Limited Population Pathway” for Antibacterial and Antifungal Drugs. “Pretomanid” was approved as part of a three-drug treatment regimen for people with extensively drug-resistant TB, multi-drug resistant TB or for patients who are treatment-intolerant or non-responsive. The three-drug regimen consists of bedaquiline, pretomanid and linezolid and is referred to as the BPaL regimen.

The combination treatment was studied in the Nix-TB trial across three sites in South Africa. Data from the Nix-TB trial showed that within six months of treatment, the combination therapy hit the mark in 90% of patients within six months, according to the nonprofit. With FDA’s recent approval, Pretomanid became only the third new anti-TB drug in more than 40 years, as well as the first drug to be developed and registered by a not-for-profit organization, thus open-sourcing the drug, in order to make it available to all the people and to all the Peoples, across the Globe equitably.

Yours,

Dr Churchill

PS:

Dr Churchill is currently the head of ALS-VC who also works in open-sourcing other major medicines, such as INSULIN and the methods of production of “Insulin” across the world, so that all the people who are diabetics or hypoglycemics, can have access to this life saving drug — BioInsulin — that is currently far too expensive for most of the Billion people suffering from this debilitating disease to be able to afford.

Dr Churchill’s knowledge of enabling the democratization and popularization through open sourcing, of various technologies such as Wi-Fi, of medicines such as “Pretomanid” and of other life saving orphan drugs as well as popular medicines — has led him to be comfortable with the business model of “open source” and the ways of creating social value, wealth and great businesses, upon it.

As a matter of fact, all these examples of revolutionary & disruptive innovation & success are based upon the distributed business & entrepreneurial model of open source, that helps bring together an alignment of value creation for People, Planet & Profit, shared equitably amongst all the geographies of our vast ecosystem.

Today, in addition to the regular generic insulin, our Open Source production facilities can produce a better and faster acting form of insulin called BioInsulin, that is a clear winner in the battle of medicinal brands and a great help to those that battle the constant threat of diabetic ketoacidosis.

For inquiries about cooperation, support and participation, in our work — please go to http://www.ALSVC.com

PPS:

Thanks to al of the great Leaders who assembled and participated in Dr Churchill’s “CEOs on Fire” Oxford UK Conference of August 14th & 15th 2019 — more money was raised for the charitable & philanthropic organizations we support, than at any other of Dr Churchill’s annual conferences in the UK…

Kudos – kudos – kudos… Well Done.