Amarin Corp Plc (AMRN)

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Relief Therapeutics US partner NeuoRx announces new formulation of RLF-100 that is stable and can be produced in large quantities - now we know why FDA was withholding EUA, they didn't meet CMC standards, didn't have a validated assay test to ensure lot to lot quality control - this is exactly why NVAX hasn't been able to file their vaccine EUA, lack of a validated assay. NRXP up almost 50% today - damn, should have bought some the other day! FDA is now able to approve their EUA. RLFTF didn't budge on the news, but their IP is still involved so they should benefit too.

https://seekingalpha.com/pr/18404222-nrx-pharmaceuticals-announces-first-successful-commercial-formulation-for-zyesami-aviptadil

NRx Pharmaceuticals Announces First Successful Commercial Formulation for ZYESAMI™

"When we began developing aviptadil for treatment of COVID-19, we discovered that the original RLF-100 formulation and manufacturing method had only a few weeks of stability, leaving hospitals unable to stock the investigational medicine in pharmacies, and leaving aviptadil out of consideration for national strategic stockpiles. Moreover, the high cost of peptide and an inability to manufacture more than 100 grams a month limited the commercial utility of aviptadil," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "We have now turned the corner and can produce both the aviptadil peptide and finished medicine in million dose quantities. We have also developed and validated the first modern chromatography assays required to ensure the purity and stability of the drug product. The new formulation method and high-speed manufacturing process adapts to the fragile nature of vasoactive intestinal peptide."

As the Delta variant and more threatening, newer mutations of the Coronavirus continue to erode the immunity created by first-generation vaccines, NRx is in active discussion with national health ministries and regulators regarding Emergency Use Authorization for ZYESAMI™ (aviptadil). The new formulation allows for the immediate shipping worldwide, upon potential EUA approval.

"Twenty years ago, Dr. Sami Said formulated the first doses of aviptadil by hand in a hospital pharmacy," said Dr. Riccardo Panicucci, a top scientific advisor to NRx. "We began this project a year ago, with 9 days of stability and an ability to manufacture about 100 doses of medicine each day. We learned through significant study and testing that the important biologic activity of this small peptide is accompanied by a fragile molecular structure that is destroyed by standard high-volume pharmaceutical manufacturing processes. Fortunately, we and our manufacturing partners have reached a greater level of commercial manufacturing, just as the pandemic seems poised to enter a new wave."

The successful new formulation and manufacturing scaleup of ZYESAMI™ allows NRx to relaunch its Expanded Access and Right to Try programs as it continues to seek Emergency Use Authorization in the United States. These programs are designed to afford patients at highest risk of death from COVID-19, and who have no other therapeutic options, the ability to access ZYESAMI™ on an investigational basis.

Partnership agreement between the two - RLFTF gets 50% of NRXP's US profits, NRXP gets 20% of RLFTF's ROW profits:

https://www.sec.gov/Archives/edgar/data/1719406/000119312521118931
/d56937dex1031.htm

Rhe-rho - appears the new formulation IP may be owned by NRXP, don't think this should impact the profit sharing agreement though:

All IP, including all Patents or Information, that is related to the Collaboration or the Product and (a) is or was created, developed, invented, made or enhanced by NeuroRx, any of its Affiliates, Dr. Javitt, or any Third Party vendor or service provider for or on behalf of NeuroRx, any of its Affiliates or Dr. Javitt, (b) is owned or licensed by NeuroRx, any of its Affiliates or Dr. Javitt, or (c) the creation, development, invention, making or enhancement of which was funded in any manner by Relief (all such IP, “Prior IP”) is set forth on Schedule A hereto.