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NRx Pharmaceuticals, Lotus Pharmaceuticals and Alvogen Inc. Announce Collaboration to Develop and Commercialize NRX-101

- NRx Pharmaceuticals, Lotus Pharmaceuticals, and Alvogen to collaborate on the further development and commercialization of NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD) for global markets

- Lotus Pharmaceuticals will acquire worldwide rights for NRX-101 for S-TRBD and will be responsible for commercialization of NRX-101 in markets outside the US through Lotus’s direct presence in certain Asian markets or through their export division, which currently has partnerships in numerous markets, including in Europe, Japan, China, Australia and Latin America

- Alvogen, through its CNS focused Almatica® division, will be responsible for U.S. commercialization of NRX-101

- NRx will be eligible to receive up to $330 million in milestone payments tied to development progress and sales targets as well as tiered double-digit escalating to the mid-teens royalty payments contingent upon certain sales thresholds in the U.S. and a fixed royalty payment for markets outside the U.S.

- Agreement includes a right of first negotiation for new indications outside of the field of bipolar depression with suicidality for NRX-101 and/or potential new products containing D-cycloserine in combination with an antidepressant / antipsychotic

Radnor, PA, Morristown, NJ and Taipei, Taiwan, June 5, 2023 -- Lotus Pharmaceuticals (1795:TT; “Lotus”), a multinational pharmaceutical company, Alvogen, a privately owned U.S. based pharmaceuticals company, and NRx Pharmaceuticals Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals or NRx”), a clinical stage biopharmaceutical company, today announced a global collaboration agreement covering the development and commercialization of NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD) for global markets.

Under the terms of the agreement, relating to NRX-101 for the U.S. market, NRx is entitled to receive an initial payment of $10 million upon achieving both a successful read-out from the ongoing Phase 2b/3 clinical trial in S-TRB and completion of a Type B meeting with the U.S. Food and Drug Administration (FDA). NRx would receive an additional payment of $5 million upon receipt of FDA approval for NRX-101 as well as bonus milestone payments of increasing amounts up to $330 million based on reaching certain net sales targets. In addition to success-based payments, NRx is eligible to receive a royalty on net sales between 12% and 16% contingent on certain sales thresholds for the U.S. market and other success-based payments for markets outside of the U.S.

Lotus will acquire worldwide rights for NRX-101 for treatment of S-TRBD and will be responsible for commercialization of NRX-101 in markets outside of the U.S. through their direct commercial presence in certain Asian markets or through Lotus’s export division where the company currently markets an extensive portfolio of products through top-tier partners. Lotus will partner with Alvogen, a longstanding partner for Lotus in the U.S., to commercialize NRX-101 for treatment of S-TRBD in the U.S. market through Alvogen’s Almatica label. Almatica is the CNS-focused division of Alvogen that currently markets six branded products. Alvogen and Lotus have committed to fund the next registrational study in suicidal treatment-resistant bipolar depression to support approval of NRX-101 contingent upon successful results of the ongoing Phase 2b/3 clinical trial and completion of a Type B meeting with the FDA. Lotus and Alvogen will have a right of first negotiation for new indications outside of the field of bipolar depression with suicidality for NRX-101 and/or potential new products containing D-cycloserine in combination with an antidepressant / antipsychotic.

Stephan Willard, J.D., Chief Executive Officer of NRx commented, “This collaboration can accelerate the delivery of NRX-101 to patients grappling with suicidal bipolar depression who desperately need better treatment alternatives. With our current resources we believe we can fund our operations until the expected Phase 2b/3 trial data. This global partnership significantly minimizes the need for future capital raises for NRX-101 development and commercialization. Alvogen and Lotus, with their CNS expertise and global operational capabilities, are ideal partners for this and possibly other NRx programs.”

Lisa Graver, Chief Executive Officer of Alvogen commented, “A medication that improves depression in bipolar patients with elevated risk of suicide would represent a significant improvement in treatment, and we view the Phase 2 STABIL-B data of NRX-101 as promising to that effect. This agreement is congruent with our strategy of developing branded CNS products with clear differentiation and patient benefit while leveraging our proven commercialization capabilities under our Almatica brand. NRX-101 provides an excellent addition to our growing CNS pipeline.”

Petar Vazharov, Chief Executive Officer of Lotus commented, “This is an exciting transaction for Lotus. Over much of the last decade, Lotus has been able to transition itself from a domestic generics Taiwanese company into a global pharma company that exports its intellectual property all over the world through either our direct presence across Asia or through our export business that includes the U.S., Japan, China, Latin America and Europe. The addition of NRX-101 to our pipeline is completely in-line with our strategic objective to drive heightened innovation that addresses significant unmet medical needs.”

An estimated seven million people are living with bipolar depression in the U.S. alone1. The risk of suicide within the group is very high, with data indicating that 50% or more of these patients will attempt suicide in their lifetime2. There are currently no medications specifically approved for people with bipolar depression and elevated levels of suicidality. NRX-101 is the first investigational medication to be specifically studied in this vulnerable patient population. Proof-of-concept data from the Phase 2 STABIL clinical trial, in which patients with bipolar depression and acute suicidality were randomized to NRX-101 or lurasidone after stabilization with one infusion of ketamine, showed a statistically significant benefit of NRX-101 vs lurasidone. Based on these data, the U.S. FDA granted Breakthrough Therapy Designation (BTD) and a Special Protocol Assessment (SPA) for NRX-101 in bipolar depression with acute suicidality.

NRx Pharma recently announced that it has upgraded and expanded its ongoing Phase 2 randomized, controlled clinical trial in bipolar depression with sub-acute suicidality to a registrational Phase 2b/3 clinical trial. Results from the ongoing Phase 2b/3 clinical trial are expected by year-end 2023. NRx will be hosting a conference call to discuss in greater detail the impact of the transaction.