Strategically Situated Georgia Inks Deal with NeuroRx for Access to ZYESAMI: Does This Violate Relief Partnership?

Strategically Situated Georgia Inks Deal with NeuroRx for Access to ZYESAMI Lawsuits Most Certainly Imminent

Georgia (formerly Republic of Georgia) lies at the intersection of Europe and Asia, literally as its west faces the Black Sea, with Russia to the north and Azerbaijan to the east. It has a population of about 3.7 million people and a history reaching far deep into antiquity—after all, this is the famed location of the magical, priceless golden fleece Jason and his Argonauts pursued in Greek Mythology. NeuroRx, developer of ZYESAMI (RLF-100 or aviptadil acetate), licensed the product from Switzerland’s Relief Therapeutics and, as TrialSite reported, the two partners appeared headed toward court. In their commercialization partnership, America’s NeuroRX would secure the United States, Canada, and Israel while Relief Therapeutics would take care of Europe and the rest of the world. Well so much for that, as recently executives from NeuroRX met with the Minister of Health of Georgia, Dr. Ekaterine Tikaradze, and other leaders to immediately initiate an Expanded Access Program (EAP) for access to ZYESAMI for critically-ill citizens of Georgia with COVID-19 respiratory failure. Done in collaboration with Denk Pharma Georgia—the nation’s primary pharmaceutical distributor—the entire deal is sponsored by a research facility funded by the U.S. Department of Defense Threat Reduction Agency known as the Richard G. Lugar Center for Public Health Research. TrialSite has reported that ZYESAMI (RFL-100) appears to have worked a number of times during the EAP as reported at various hospitals where the drug was used on an emergency basis. The request for emergency use authorization with the FDA was rejected and apparently that appeared to trigger growing tensions between the two partners. 

COVID-19 in Georgia

Georgia’s been proportionately hit hard by the pandemic. With only 3.7 million, they have reported over 311,000 cases of the coronavirus with 4,137 deaths. Georgia experienced little problem in the first part of the pandemic. It wasn’t till October 2020 that a huge spike in cases hit the country. The apex of this wave was December 5, 2020 with 5,450 cases in one day. Since then, the cases waned until April when the infection rate climbed again.

Currently about 30,000 people have been vaccinated with either the Pfizer/BioNTech or AstraZeneca vaccines, reports Georgia’s National Center for Disease Control

With a variegated natural landscape, the southwest part of the country on the Black Sea is considered subtropical and a tourist destination. According to the U.S. Embassy in Georgia, while COVID-19 infection transmission is widespread, travel is allowed there with a negative COVID-19 viral test done three days prior to travel date.

THE EAP

The Georgian Ministry of Health has granted approval for the EAP that’s already approved by the U.S. FDA (NCT0445839) to be initiated in this nation and potentially in other neighboring countries in the Caucasus Region under the oversight of the Georgian Ministry of Health.

Note this would be a direct apparent violation of the commercial agreement with Relief Therapeutics but more on that later. Minister Tikaradze went on the record, “We in Georgia are enthusiastic about Dr. Anthony Fauci’s recent announcement of NeuroRx and ZYESAMI as an industry partner in the NIH ACTIV3b trial. We are pleased to initiate an Expanded Access Program of ZYESAMI in Georgia under our oversight with the participation of Denk Pharma Georgia and the Lugar Center for Public Health Research.”

NeuroRx Expansion in the Caucuses

In their initial license agreement, NeuroRX was to solely commercialize the USA, Canada and Israel. TrialSite reported on growing tension between the two “partners” in conjunction with NeuroRX signing an agreement to merge with Black Rock Partners Acquisition Corp (Nasdaq: BRPA).

In this recent meeting, NeuroRX CEO noted, “In the coming weeks, we look forward to announcing broader programs involving immunization strategies as well as COVID-19 therapeutics to serve the people of the Caucasus Region.”

So clearly, that commercial contract carving up the world between NeuroRx and Relief Therapeutics is off the table, unless they have agreed to some new territorial alignment.

Contested Terrains

Of course, Georgia lies geopolitically in an incredibly important area, at the crossroads of two vast continents, and adjacent to the Caucasus Mountains rich with adjacent oil deposits in Kazakhstan and Azerbaijan. Now NeuroRX, not a large company, enters the international markets via an apparent invitation from, or sponsorship by, the Richard G. Lugar Center for Public Health, based on the Georgian National Center for Disease Control and Public Health, fully operational by 2013. Named in honor of former U.S. Senator Richard G. Lugar to support an international research effort in its endeavor to stop global diseases, this center is apparently the highest level of laboratory network in the country of Georgia, representing the public health system referral library according to a news entry from the U.S. Army Medical Research and Development Command

In the age of COVID-19, vaccine and therapeutic deals go hand in hand with diplomacy. Currently, business development on behalf of producers from the three biggest vaccine producers, the U.S., China and Russia, criss cross the globe doing deals. Georgia is of strategic import, at such a strategic location at the crossroads of the continents and a former territory of the Soviet Union. It’s certainly intriguing that NeuroRX surfaced here doing a strategic deal. 

The Dispute

TrialSite discussed the tension between these two companies that appears to be headed to a court room, which includes the following issues:

  • NeuroRx hasn’t supplied Relief Therapeutics with clinical trial data that according to the latter, is part of the licensing and commercialization agreement known as the “Collaboration Agreement.” NeuroRx has essentially shut down communications
  • NeuroRx is owed $4 million in unpaid invoices but Relief Therapeutics counters that many of the “alleged” expenses are “not substantiated by valid, verifiable invoices.” Relief claims that NeuroRX lack of transparency precludes it from settling up.
  • While NeuroRx declared that Relief failed to fund an obligated clinical trial (evaluating inhaled aviptadil), Relief’s position is that it needs again material information to make the decision as to whether to fund or not.
  • While NeuroRx now challenges the net profit share in its designated territories (USA, et al) Relief suggests that the agreement is not impacted
  • NeuroRx challenges Relief that “questions about the formulation of aviptadil that Relief has contributed to the parties’ collaboration” implying there are quality issues with the product. Relief’s counter centers on the fact that the two parties were aware of any and all issues discussed when they had a meeting of the minds to proceed with contracting the partnership.

Now that NeuroRX is doing deals right at the crossroads of Europe and Asia, where Jason and his Argonauts sought that priceless Golden Fleece, NeuroRx gets some help with its own set of Argonauts.

Denk Pharma

This deal was done in conjunction with Denk Pharma Georgia. Denk Pharma apparently goes back to 1948 in Munich as a pharmaceutical and food supplement exporter.

Responses

  1. The Trail is an investigational process, not a comercialization phase. IV version trails are on charge of NeuroRx. Thats the constractual agreement. There’s no issues on that. This article doesn’t have good intentions and in terms on contractual matter, totally wrong. FDA rejected the drug on DECEMBER because of the newwwww guidelines for 60 days data. Theres a new FDA EUA submittion with the requested data. VERY IRRESPONSIBLE ARTICLE.

  2. No lawsuits are eminent. Nuerorx is under a collaboration agreement with relief therapeutics to market the drug. Marketing area has no restrictions. Profit percentages are designated areas. Apparently the two are being confused. Nuerorx had an opportunity to market and they are simply doing their job of which they were hired to do.