Lotus, Alvogen, NRx Pharmaceuticals Collaborate To Develop And Commercialise NRx-101

KUALA LUMPUR, June 6 (Bernama) -- Lotus Pharmaceuticals, a multinational pharmaceutical company, has announced a global collaboration with Alvogen, a privately owned United States (US)-based pharmaceuticals company, and NRx Pharmaceuticals Inc (NRx), a clinical stage biopharmaceutical company.

According to a statement, the global collaboration agreement covering the development and commercialisation of NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD) for global markets.

“This is an exciting transaction for Lotus. 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,” said its Chief Executive Officer, Petar Vazharov.

Under the terms of the agreement, relating to NRX-101 for the US market, NRx is entitled to receive an initial payment of US$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 US Food and Drug Administration (FDA). (US$1=RM4.59)

NRx would receive an additional payment of US$5 million upon receipt of FDA approval for NRX-101 as well as bonus milestone payments of increasing amounts up to US$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 per cent and 16 per cent contingent on certain sales thresholds for the US market and other success-based payments for markets outside of the US.

Lotus will acquire worldwide rights for NRX-101 for treatment of S-TRBD and will be responsible for commercialisation of NRX-101 in markets outside of the US 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 to commercialise NRX-101 for treatment of S-TRBD in the US 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.

-- BERNAMA