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COEUS Holdings Announces Rebranding to Reflect the Unification of Each Business Unit Into One Entity

Businesswire | May 02, 2023 | Read time : 02:00 min

COEUS Holdings Announces

COEUS, a leading healthcare communications, technology, talent, and consulting firm delivering a variety of services and platforms to all stakeholders in the healthcare ecosystem, announced today that it has completed a major rebranding. Following nearly 14 years of both organic growth and acquisitions, all business units have been combined to form one entity: COEUS.

Since the company’s inception in 2009, the company sought to build a suite of services capable of providing end-to-end solutions for drug and therapy manufacturers ranging from preapproval, through launch, and eventual loss of exclusivity.

“A little over 13 years ago, we started this company with just one employee. After a series of acquisitions, the hiring of more than 140 people, and the creation of numerous distinct business units all coming online at different times, we felt it was a necessary part of our evolution to consolidate the business units to one entity capable of servicing all clients,” stated Marc Hixson, CEO, COEUS. “Our clients have routinely told us that our experts, our strategic vision of what healthcare should be, and our commitment to leveraging — and building — technologies that improve the biotech, pharmaceutical, and payer audiences truly sets COEUS apart. It’s time to let the rest of the industry in on it.”

Through the rebranding, the company has redesigned its logo, launched an entirely new website and reinvented all its marketing collateral to reflect the company’s new identity.

As part of the consolidation, COEUS has appointed Jodie McVan to the position of Chief Commercial Officer. In her new role, Jodie will oversee the day-to-day operations, staffing, and the management of existing offerings, as well as drive the creation of new services and products for the consulting and agency business.

“With the combination of end-to-end service offerings for manufacturers, our technology platforms and services for manufacturers and payers alike, and industry leading talent and deep subject matter expertise, COEUS is well-positioned to efficiently deliver world-class service to our clients,” stated Jodie McVan, Chief Commercial Officer, COEUS. Visit 1COEUS.com to explore the new website and brand.

About COEUS

Established in 2009, COEUS is a leading healthcare consulting, communications, technology, and talent firm. The company offers clients a variety of services, as well as SaaS technology platforms, for various stakeholders throughout the healthcare ecosystem including all payers and emerging or more established drug manufacturers. Leveraging the deep knowledge and experience of the company’s many subject matter experts, COEUS works on all drug types with a particular focus on cell and gene therapies, rare diseases, and oncology. The company also has unique expertise in the creation and management of value-based agreements by leveraging COEBRA™, the company’s evidence and outcomes adjudication platform. In its 13-year history, the company has supported the launch of more than 120 pharmaceutical brands and has worked with more than 300 pharma clients including many top global pharmaceutical manufacturers.

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Tonix Pharmaceuticals Completes Enrollment in Potentially NDA-Enabling Phase 3 RESILIENT Trial of TNX-102 SL for Management of Fibromyalgia

Globenewswire | August 02, 2023

Tonix Pharmaceuticals Holding Corp. a biopharmaceutical company, announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL sublingual tablets) 5.6 mg in fibromyalgia and expects topline data next quarter. A total of 457 participants were randomized. TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia. If successful, we believe this will be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA). “The completion of enrollment in our Phase 3 RESILIENT trial is a significant milestone for both Tonix and the fibromyalgia community,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Currently-approved treatments have not fully met the needs of fibromyalgia patients and there has not been a new FDA-approved therapy for the condition since 2009. TNX-102 SL has the potential to be a new non-addictive, non-opioid bedtime medication with broad spectrum symptom coverage and which can be used on a chronic basis for the management of fibromyalgia. With all other clinical, nonclinical and CMC requirements for an NDA submission achieved, we are looking forward to the upcoming data readout and an expeditious filing of an NDA.” In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia. TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies. The most common treatment-emergent adverse events were oral hypoesthesia, oral paresthesia, and product taste abnormal. About the Phase 3 RESILIENT Study The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial randomized 457 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. Tonix Pharmaceuticals Holding Corp. Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment in a potentially registration-enabling study, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023.

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Everest Medicines Announces Partner Calliditas Therapeutics Receives FDA Priority Review for Full Approval of Nefecon®

PRNewswire | August 21, 2023

Everest Medicines announced that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20, 2023. "We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible." The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023. The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of approximately 3mL/min per year using a robust regression method of analysis. The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon® break-through therapy designation and NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China. About Nefecon® Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.

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Multistakeholder Collaborations are Vital to Advancing Technologies in Parkinson's

PRNewswire | July 10, 2023

Critical Path Institute (C-Path) and the Center for Health + Technology (CHeT) at University of Rochester today announced the release of two seminal publications about digital health technologies for Parkinson's. These technologies, such as smartphones and wearable sensors, offer an opportunity for objective, frequent and remote assessment of people with Parkinson's. With 10 million people living with Parkinson's worldwide, collaboration and data sharing are crucial for driving innovation in drug development for the fastest-growing degenerative neurological condition. Research leaders at CHeT have joined forces with organizations and regulators through C-Path's Critical Path for Parkinson's (CPP) Consortium, a precompetitive public-private partnership. CPP aims to accelerate the regulatory endorsement of digital tools in Parkinson's clinical trials through its Digital Drug Development Tools (3DT) initiative. In June 2023, the Journal of Parkinson's Disease published two open access manuscripts, representing companion papers from this partnership that detail steps in conducting interviews of people with Parkinson's who participated in a clinical research study using smartphones. The manuscripts report on relevant symptoms in early Parkinson's and assess the relevance of digital measures from a smartphone application and smartwatch from the patient perspective. The study was led by Jamie Adams, M.D., Associate Professor of Neurology and Associate Director of CheT at the University of Rochester and Jennifer Mammen, Ph.D., Assistant Professor at the University of Rhode Island, with support from CPP. "This project pioneers a new path to efficiently advance tools aligned with the patient voice by engaging with regulatory agencies early and often," said Diane Stephenson, Ph.D., CPP Executive Director. "C-Path remains committed to learning what matters most to people living with Parkinson's." "These manuscripts describe a novel methodology that will help inform the use of digital health technologies in clinical trials for Parkinson's disease and support more objective and patient-centered measures. The goal is to enable efficient, data-driven, and patient-centric utilization of digital health technologies to speed therapeutic development," said Adams. "Sharing the results with the study participants and witnessing how this information helped them in new ways has been most rewarding." John Crawford, a CPP advisor, Parkinson's advocate, and manuscript coauthor states, "Digital health technologies have the potential to significantly impact Parkinson's management and have already revolutionized clinical trial conduct. Their advancement expedites trials, enhances intelligence, reduces costs, and ultimately accelerates the delivery of new therapies and technologies to patients." The new publications coincide with CPP's participation in the World Parkinson's Congress taking place in Barcelona, Spain July 4-7, 2023. CPP will present two posters, Recommendations for Parkinson's Clinical Trials using Digital Health Technologies and Worldwide Collaborative Framework for Optimizing New Parkinson's Treatment Trials with Patient Centric Outcome Measures, at the conference coauthored by people living with Parkinson's highlighting the importance of worldwide collaborations. About Critical Path Institute Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. C-Path FDA Acknowledgement The Center for Health + Technology (CHeT) is an academic research organization within the University of Rochester Medical Center. We are comprised of six units, with expertise in clinical trials coordination, clinical materials services, patient and caregiver-reported outcome measures, tech research and innovation, data modeling and predictive analysis, and health policy. Our skilled team of consultants are readily available to provide guidance to academic institutions, pharmaceutical companies, technology firms, not-for-profit foundations, advocacy groups, and the federal government.

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Tonix Pharmaceuticals Completes Enrollment in Potentially NDA-Enabling Phase 3 RESILIENT Trial of TNX-102 SL for Management of Fibromyalgia

Globenewswire | August 02, 2023

Tonix Pharmaceuticals Holding Corp. a biopharmaceutical company, announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL sublingual tablets) 5.6 mg in fibromyalgia and expects topline data next quarter. A total of 457 participants were randomized. TNX-102 SL is in development as a non-opioid, centrally acting analgesic, to be taken daily at bedtime for the management of fibromyalgia. If successful, we believe this will be the final, well-controlled efficacy trial required for submission of a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA). “The completion of enrollment in our Phase 3 RESILIENT trial is a significant milestone for both Tonix and the fibromyalgia community,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Currently-approved treatments have not fully met the needs of fibromyalgia patients and there has not been a new FDA-approved therapy for the condition since 2009. TNX-102 SL has the potential to be a new non-addictive, non-opioid bedtime medication with broad spectrum symptom coverage and which can be used on a chronic basis for the management of fibromyalgia. With all other clinical, nonclinical and CMC requirements for an NDA submission achieved, we are looking forward to the upcoming data readout and an expeditious filing of an NDA.” In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia. TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. TNX-102 SL was generally safe and well tolerated in patients with fibromyalgia, with overall adverse event profile comparable to prior fibromyalgia studies. The most common treatment-emergent adverse events were oral hypoesthesia, oral paresthesia, and product taste abnormal. About the Phase 3 RESILIENT Study The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial randomized 457 participants in the U.S. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. Tonix Pharmaceuticals Holding Corp. Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment in a potentially registration-enabling study, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023.

Read More

Views and Analysis

Everest Medicines Announces Partner Calliditas Therapeutics Receives FDA Priority Review for Full Approval of Nefecon®

PRNewswire | August 21, 2023

Everest Medicines announced that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20, 2023. "We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible." The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023. The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of approximately 3mL/min per year using a robust regression method of analysis. The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon® break-through therapy designation and NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China. About Nefecon® Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.

Read More

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Multistakeholder Collaborations are Vital to Advancing Technologies in Parkinson's

PRNewswire | July 10, 2023

Critical Path Institute (C-Path) and the Center for Health + Technology (CHeT) at University of Rochester today announced the release of two seminal publications about digital health technologies for Parkinson's. These technologies, such as smartphones and wearable sensors, offer an opportunity for objective, frequent and remote assessment of people with Parkinson's. With 10 million people living with Parkinson's worldwide, collaboration and data sharing are crucial for driving innovation in drug development for the fastest-growing degenerative neurological condition. Research leaders at CHeT have joined forces with organizations and regulators through C-Path's Critical Path for Parkinson's (CPP) Consortium, a precompetitive public-private partnership. CPP aims to accelerate the regulatory endorsement of digital tools in Parkinson's clinical trials through its Digital Drug Development Tools (3DT) initiative. In June 2023, the Journal of Parkinson's Disease published two open access manuscripts, representing companion papers from this partnership that detail steps in conducting interviews of people with Parkinson's who participated in a clinical research study using smartphones. The manuscripts report on relevant symptoms in early Parkinson's and assess the relevance of digital measures from a smartphone application and smartwatch from the patient perspective. The study was led by Jamie Adams, M.D., Associate Professor of Neurology and Associate Director of CheT at the University of Rochester and Jennifer Mammen, Ph.D., Assistant Professor at the University of Rhode Island, with support from CPP. "This project pioneers a new path to efficiently advance tools aligned with the patient voice by engaging with regulatory agencies early and often," said Diane Stephenson, Ph.D., CPP Executive Director. "C-Path remains committed to learning what matters most to people living with Parkinson's." "These manuscripts describe a novel methodology that will help inform the use of digital health technologies in clinical trials for Parkinson's disease and support more objective and patient-centered measures. The goal is to enable efficient, data-driven, and patient-centric utilization of digital health technologies to speed therapeutic development," said Adams. "Sharing the results with the study participants and witnessing how this information helped them in new ways has been most rewarding." John Crawford, a CPP advisor, Parkinson's advocate, and manuscript coauthor states, "Digital health technologies have the potential to significantly impact Parkinson's management and have already revolutionized clinical trial conduct. Their advancement expedites trials, enhances intelligence, reduces costs, and ultimately accelerates the delivery of new therapies and technologies to patients." The new publications coincide with CPP's participation in the World Parkinson's Congress taking place in Barcelona, Spain July 4-7, 2023. CPP will present two posters, Recommendations for Parkinson's Clinical Trials using Digital Health Technologies and Worldwide Collaborative Framework for Optimizing New Parkinson's Treatment Trials with Patient Centric Outcome Measures, at the conference coauthored by people living with Parkinson's highlighting the importance of worldwide collaborations. About Critical Path Institute Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. C-Path FDA Acknowledgement The Center for Health + Technology (CHeT) is an academic research organization within the University of Rochester Medical Center. We are comprised of six units, with expertise in clinical trials coordination, clinical materials services, patient and caregiver-reported outcome measures, tech research and innovation, data modeling and predictive analysis, and health policy. Our skilled team of consultants are readily available to provide guidance to academic institutions, pharmaceutical companies, technology firms, not-for-profit foundations, advocacy groups, and the federal government.

Read More

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