Monday, September 21, 2020 1:01:02 AM
The two companies have now taken steps to increase manufacturing of the aviptadil drug substance and are in the final stages of contracting with a fill/finish manufacturer, along with a national distribution partner. By January 2021 , Relief and NeuroRx expect to have manufacturing, distribution and logistics capacity in place to deliver sufficient drug quantities to treat 150,000 patients per month with RLF-100. The companies continue to anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks.
As part of their agreement, Relief and NeuroRx intend to pursue the issuance of trademarks on RLF-100. NeuroRx shall prosecute such trademarks in the U.S. , Canada and Israel , while Relief shall prosecute trademarks in all other territories.
Raghuram (Ram) Selvaraju , Chairman of the Board of Relief , said: "We are pleased to reach this agreement with NeuroRx , a partner we believe is best suited to ensure rapid clinical development as well as timely and expedient interaction with regulatory authorities in what is likely to be the most important market for the drug, the United States . We are looking forward to collaboratively and productively working together in order to maximize the value of the overall franchise for our shareholders and get this potentially life-saving drug to patients as swiftly as possible."
Jonathan C. Javitt , Chief Executive Officer of NeuroRx , added: "As the global pandemic continues to devastate families and communities, our small team is encouraged by the early promise we have seen in Sami Said's scientific legacy and we are working around the clock to bring this drug to patients."
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