NRX Pharmaceuticals Inc.

27/06/2024 | Press release | Distributed by Public on 27/06/2024 20:58

Termination of Material Agreement Form 8 K

Item1.02 Termination of a Material Definitive Agreement.

On June 21, 2024, NRx Pharmaceuticals, Inc. (the "Company" received a notice of termination of Exclusive, Global - Development, Supply, Marketing & License Agreement, dated as of June 2, 2023, as amended dated February 7, 2024 ("Amendment"), by and between the Company, Alvogen, Inc., Alvogen Pharma US, Inc. and Lotus Pharmaceutical Co. Ltd (collectively, "Alvogen") (together with the Amendment, the "Agreement"), effective immediately. The Agreement provided for the joint development, supply, marketing, commercialization and license to Alvogenof NRX-101. NRX-101 is an FDA-designated investigational breakthrough therapy for suicidal treatment-resistant bipolar depression and chronic pain. The Company partnered with Alvogen around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression.

Under the terms of the Agreement, the Company and Alvogen will, in good faith, discuss, negotiate and seek to agree to a royalty amount due Alvogen by the Company within the next thirty (30) days. In its notice of termination, Alvogen states that the amounts incurred by or on behalf of Alvogen and its affiliates in connection with the exploitation of NRX-101 is $113,405 plus an additional $4,389,300, representing reimbursement of an advance milestone payment paid to the Company by Alvogen in February 2024 in connection with the Amendment, and reimbursable costs under the Agreement ("Advanced Amounts"). The Advanced Amounts represent, in addition to other reimbursable amounts, amounts paid by Alvogen to the Company's service providers that performed services with respect to the Company's development of NRX-101.

Alvogen's termination of the Agreement resulted from Alvogen's perspective that broad approval of NRX-101 would require clinical trials enrolling 500 or more patients, an investment that Alvogen is not currently prepared to undertake. The Company's perspective, informed by U.S. regulatory counsel, including former senior officials from the Food and Drug Administration, is that recent clinical trial findings demonstrating reduced suicidality and akathisia with NRX-101 compared to standard of care, combined with confirmatory data from other trials, constitute a basis for filing an application this year for Accelerated Drug Approval, based on the previously awarded Breakthrough Therapy Designation. This application would focus upon patients with bipolar depression who demonstrate suicidality or akathisia on currently-approved medication and have no viable therapeutic alternative - an addressable indication that current market research estimates at approximately $3.7 billion annually, not including the market for NRX-100 in suicidal depression. This is a population management believes the Company can readily address without a large commercial partner, given the relatively small number of psychiatrists who treat high-risk patients. Subsequent clinical trials would have the potential to broaden the addressable population to the estimated 7 million patients with bipolar depression.

In addition to the Accelerated Approval submission for NRX-101, the Company continues to finalize a New Drug Approval application for intravenous ketamine (NRX-100), to be submitted this year.