Globenewswire | June 06, 2023
Lotus Pharmaceuticals 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.
Up to 50% of individuals with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide3. The only FDA-approved treatment for patients with treatment-resistant suicidal bipolar depression remains electroconvulsive therapy.
Conventional antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101 is a patented, oral, fixed dose combination of D-cycloserine and lurasidone, neither of which has shown addiction potential in preclinical models. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from the FDA for the treatment of severe bipolar depression in patients with Acute Suicidal Ideation & Behavior (ASIB) after initial stabilization with ketamine or other effective therapy.
NRX-101 is one of the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as PTSD and other indications. To date, NRX-101 is the only oral NMDA investigational medicine focused on bipolar depression in patients with acute and sub-acute suicidality.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for the treatment of central nervous system disorders, specifically bipolar depression with suicidality and post-traumatic stress disorder (PTSD). The company's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor and is being investigated in a Phase 2b/3 clinical trial for Suicidal Treatment-Resistant Bipolar Depression, which includes patients with both acute and sub-acute suicidality, an indication for which the only approved treatment is electroshock therapy. The company's prior Phase 2 STABIL-B clinical trial evaluating NRX-101 in patients with Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB) demonstrated a substantial improvement over available therapy in reducing depression and suicidality compared to placebo when patients were treated with NRX-101 after a single dose of ketamine. Based on the fin
dings from the STABIL-B trial, the U.S. Food and Drug Administration (FDA) granted a Special Protocol Agreement and Breakthrough Therapy Designation for NRX-101 in patients with Severe Bipolar Depression with ASIB.
Alvogen is a privately held pharmaceutical company focused on developing, manufacturing and selling generic and branded products for the US market. The company has a diverse portfolio and pipeline that includes both branded and generic products across various administration forms. The Alvogen-family of companies includes Alvogen US (Generics), Almatica (Brands) and Almaject (Injectables).
Almatica Pharma LLC is a wholly owned subsidiary of Alvogen, Inc. and is a U.S. pharmaceutical company focused on the development, acquisition and commercialization of branded pharmaceutical products. Its current product portfolio covers a range of therapeutic areas, but promotional focus is on central nervous system disorders and conditions.
Founded in 1966, Lotus is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan
BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 24, 2023
Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).
Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.
“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”
The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.
“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”
“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.
Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | March 27, 2023
Massive Bio, Inc., a private AI-enabled oncology startup that provides virtual and in-person concierge services for cancer patients, and NeoGenomics, Inc. a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announced a collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world. NeoGenomics will identify patients in real time who may be eligible for clinical trials based on biomarker status. Following initial contact and outreach provided directly from NeoGenomics to the treating physician, Massive Bio will help obtain patient consent and expediate additional screening and potential enrollment. This partnership will help to quickly identify patients eligible for clinical trials and help patients and providers make an informed decision regarding their potential treatment avenue.
By combining their respective strengths in biomarker testing, data analysis, machine learning, and biomarker and genomic profiling, the collaboration between NeoGenomics and Massive Bio have achieved a significant milestone in the oncology industry.
"Our mission at Massive Bio is to provide cancer patients with the best possible care and treatment options,” said Selin Kurnaz, PhD, CEO and co-founder of Massive Bio. “By partnering with NeoGenomics, a leading player in the cancer diagnostics industry that shares Massive Bio’s commitment to advancing cancer research and improving patient outcomes, we can leverage their expertise in oncology diagnostics to accelerate the identification of patients who may be eligible for clinical trials."
“NeoGenomics’ advanced diagnostic tools and U.S. footprint, combined with Massive Bio's AI capabilities and concierge services in oncology, will enable us to match patients to clinical trials faster and more efficiently, resulting in improved outcomes and reduced costs,” said Vishal Sikri, President of the Advanced Diagnostics Division of NeoGenomics. “We are thrilled to partner with Massive Bio to advance precision medicine and improve the delivery of healthcare services to patients, pharmaceutical partners, and healthcare providers."
Dr. Arturo Loaiza-Bonilla, MD, co-founder and Chief Medical Officer of Massive Bio, added, "This collaboration between NeoGenomics and Massive Bio will enable us to provide patients with personalized care and support throughout their cancer journey, and move the needle forward in precision oncology and research."
Massive Bio empowers cancer patients to find their best treatment options, using artificial intelligence to improve equitable access and precision targeting for clinical trial matching, drug matching, and drug development. Massive Bio combines its best-in-class AI platform with technology-enabled services to remove barriers in clinical trial enrollment, value-based oncology decisions, and data-driven cancer treatment. The company serves more than two dozen pharmaceutical companies, contract research organizations, and hospital networks, and has been awarded an SBIR contract by the National Cancer Institute. Massive Bio was founded in 2015 by clinical, technology, and M&A executives, and has a global presence with nearly 100 people in 12 countries.