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
Businesswire | June 02, 2023
REALM IDx announced the launch of REALM Pharma Services, an end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners. Through a strategic integration, REALM Pharma Services brings together the research arms of subsidiaries, Ambry Genetics and Invicro, to offer cutting-edge genomics, traditional and molecular pathology, and advanced imaging and spatial biology. Combined with machine learning and artificial intelligence (AI) from REALM’s informatics organization, the company believes this end-to-end service can help reveal new insights and develop multi-dimensional models for drug discovery and validation.
“We are excited to offer a comprehensive multiomic and multimodal program that has been tailored to support the needs of our biopharma partners,” said Aaron Elliott, PhD, CEO of REALM IDx. “We believe the integrated approach offered through REALM Pharma Services is a transformative shift in research and will bring new, data-driven insights to precision medicine.”
Use of advanced omics, including single-cell omics, is increasingly being incorporated by biopharma into discovery and research efforts, particularly in the field of cancer. This approach can support improved understanding of biological complexity in immuno-oncology and a system-wide path to drug efficacy. However, a significant challenge has been the lack of a consolidated infrastructure to not only support analytical testing and data collection, but also computational analysis of unique data sets to find novel associations for translational insights.
“In supporting our biopharma partners, we see ourselves as a powerful connecting force,” said Jonathan Usuaka, PhD, Chief Strategy and Informatics Officer for REALM IDx. “Along with world-class genomics, pathology, spatial imaging and analysis services, we support real-world data and advanced analytics to inform drug development at every stage.”
The company will introduce REALM Pharma Services while exhibiting at the upcoming American Society of Clinical Oncology annual conference in Chicago, June 3 – 5. While at the conference, the company will also share details of a new comprehensive genomic profiling test (CGP) for cancer developed in collaboration with its partners in Japan and set to launch this summer. Additional information about REALM Pharma Services may be found on REALM’s website.
About REALM IDx
REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets.
Globenewswire | June 01, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
“The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”
The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1
The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST.
“This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.”
About Ciltacabtagene Autoleucel (cilta-cel)
Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5
Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9
In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13
About the Janssen Pharmaceutical
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.