Innovation Pharmaceuticals Inc (IPIX)

[CallMeCrazy]

IS THERE A BUSINESS DEVELOPMENT PLAN FOR B-COVID?

I think the way Gilead Sciences quickly responded to the pandemic with their investigational drug, Remdesivir, could be instructive for IPIX and our investigational drug, Brilacidin.

The first thing Gilead did was recognize the urgency of the situation and that billions of dollars will go to those few "first responders" drug companies. Even before their U.S. EUA for Remdesivir was approved Gilead increased its manufacturing capacity for Remdesivir in anticipation of worldwide demand and started a P-3. According to the Biorender Vaccine and Therapeutic drug tracker, there are 419 COVID-19 therapeutic drugs in clinical trials. Competition is on the way and it's "the early bird that catches the worm."

The next step I see in Gilead's plan was after they secured a U.S. EUA for Remdesivir, they ran up the global count for Remdesivir EUAs. The FDA authorized Remdesivir on May 1, 2020 and to date, Remdesivir is approved or authorized for emergency use to treat COVID-19 in around 50 countries. Remdesivir has been authorized for emergency use in India, Singapore, and approved for use in Japan, the European Union, the United States, and Australia for people with severe symptoms.

In order to increase the global supply of Remdesivir Gilead turned to: Voluntary Licensing Agreements

Gilead has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand supply of remdesivir. The agreements allow the companies – Cipla Ltd.; Dr. Reddy's Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access. The regulatory approval status of remdesivir varies by country, and the distribution of remdesivir within each country listed below is subject to local laws and regulations.


Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir

It is this type of pandemic situational awareness and execution that accounts for how Remdesivir for COVID-19 earned $2.7B in the 8 months after receiving an EUA in May 2020 and Gilead projected aggregate sales of nearly $16B through 2026 and the WHO says this drug has little to no effect on COVID-19.
https://www.statista.com/statistics/1143040/remdesivir-sales-forecast-worldwide/

The world still needs an effective broad-spectrum antiviral for the treatment of C-19 and the first ones to market, via EUA, will earn billions in yearly revenues.

IT'S TIME FOR B-COVID MARKET DEVELOPMENT TO TAKE PRECEDENCE OVER PIPELINE DEVELOPMENT

In Leo's May 13th PR he stated, " Development work related to the formulation and manufacture of Brilacidin in capsule form is underway to support our Phase 2 trial in Ulcerative Colitis planned to commence this year. Additional work tied to starting, in 2022, a planned Phase 3 study of Brilacidin in Oral Mucositis is also in progress. We aim to maintain momentum across our clinical programs.”

Are you kidding me, Oral Mucositis is a $500M market and we're years away from a revenue-generating IBD drug. Why are we expending time,and resources that we will need for studies geared at expanding the categories of usage for B-COVID?

Leo, I know it is premature to discuss post-EUA plans before we have P-2 results, but I wonder if you have or will have a plan to:

1. Obtain substantial B-COVID global manufacturing capacity.
2. Obtain global portfolio of Emergency Use Authorizations.
3. Obtain global portfolio of Voluntary Licensing Agreements.

IMO, the EUAs Leo should seek among the first are the U.S., India, China, EU, & The WHO. I believe these EUAs are the most valuable.

It should also be noted that when IPIX receives an EUA for B-COVID, there is nothing that requires IPIX to do a P-3, however, if no P-3 is in progress when the first EUA review comes then the EUA might be withdrawn. I raise this point because B-COVID could, quite possibly, generate billions in revenue without ever having a P-3 done. If Gilead had not done a Remdesivir P-3, Remdesivir would have still generated $2.7B in 2020 revenues earned in the first 8 months of its EUA.

What IPIX need is CASH. What the world needs are COVID-19 remedies/solutions for which they're willing to pay billions. Why don't we globally monetize B-COVID to the maximum extent possible and, thereafter, add to the mix pipeline development priorities (including B-COVID P-3) consistent with B-COVID revenue?

Leo should, "go-for-the-gold", and focus on the global maximization of B-COVID revenues by overseeing the manufacture and distribution of B-COVID. The revenue should roll-in fairly quickly assuming Leo has had the foresight to put the proper B-COVID infrastructure in place, like Gilead did for Remdesivir. I think he does. We'll see.