PHARMA TECH
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.
About NRX-101
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.
About Alvogen
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.
About Lotus
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
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PHARMACY MARKET, PHARMA TECH
Businesswire | April 12, 2023
Shields Health Solutions the premier specialty pharmacy accelerator in the country, announces that it is partnering with Elliot Health System, the largest provider of comprehensive healthcare services in Southern New Hampshire, to launch a new pharmacy program to meet the unique needs of patients with complex, chronic conditions. The program will increase access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
The program with Elliot Health System and Shields will initially serve a variety of disease states and clinics including rheumatology, gastroenterology, neurology, pulmonology, oncology, endocrinology and family medicine. Specialty pharmacy liaisons will guide patients and caregivers who fill prescriptions with Elliot Health System and will work with patients on-site. These liaisons can assist patients and families with navigating barriers to care, such as health insurance prior authorizations or securing financial assistance, regardless of the location where they fill their prescription.
“Through our partnership with Shields, we can provide Elliot patients, and patients from other health care systems in our community, with expanded access to critical medications to achieve even greater positive health outcomes, particularly for the patients who require the highest degree of expertise to meet their needs,” said Molly Mortimer, Elliot Health System Director of Pharmacy Services. “We are pleased to join the Shields network to ensure we are doing all that we can to best care for our community.”
Expanded patient support services, combined with access to recently approved and newly available specialty medications, give patients greater availability for onsite treatment options. Shields currently partners with more than 75 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery — often within two days — and improved medication adherence greater than 90 percent on average.
“Through a commitment to outstanding complex patient care and its position as a health care leader in the region, Elliot Health System, and SolutionHealth as a regional system, align well with Shields’ core mission and will make it a highly valued addition to our membership,” said John Lucey, Chief Executive Officer at Shields. “By securing access to 90 percent of the limited distribution drugs that complex patients need and opening the door to restricted payer networks, our partnership will elevate access to affordable care, while improving therapy management and care coordination for Elliot Health System’s patients.”
About Shields Health Solutions
Shields Health Solutions is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.
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PHARMACY MARKET
Businesswire | May 11, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster.
The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs. That localized exposure data is then utilized to inform the ILDsym™ or IPFsym™ platforms for efficacy predictions. As client ventures launch and progress, Simulations Plus scientists will leverage their 40+ years of combined experience in pulmonary exposure and efficacy modeling to train in-house client experts on how to use the software and create models to accurately predict the exposure and efficacy of their pulmonary assets.
“Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures,” explained Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus. “We anticipate that the use of our targeted pulmonary package could lead to an acceleration in the development of treatments to slow or even halt progression of these diseases. By integrating the industry-leading platforms for PBPK/PCAT™, quantitative systems pharmacology (QSP), and the expertise of our scientists, along with the training of in-house scientists, we believe we can help our clients develop therapies that will improve and even extend the lives of patients worldwide.”
“Hiring and retaining skilled modelers is difficult, which is why many companies develop talent from within,” noted Vice President of Business Development Josh Fohey. “While we are always pleased to assist with our clients’ drug development programs as an extension of their team, we also want to empower them to engage with their models and data beyond what is typical with consulting relationships. As part of our Pulmonary Package, client teams benefit from a customized learning package using the tools in their program, implemented with support and guidance from our experts. Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.”
About Simulations Plus
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.
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