Home > News > featured news > Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets

BUSINESS INSIGHTS, PHARMACY MARKET

Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets

Globenewswire | March 30, 2023 | Read time : 02:00 min

Aquestive Therapeutics Expands

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced it has expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes, extends and expands the lifecycle of established medicines, for Libervant™ Buccal Film to cover the rest of the world, excluding the United States, Canada, and China. The original licensing agreement with Pharmanovia announced in September 2022 covered the European Union, United Kingdom, Sweden, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA).

“We are pleased to announce the expansion of our collaboration with Pharmanovia,” said Daniel Barber, Chief Executive Officer of Aquestive. “We believe Pharmanovia’s experience and geographic footprint align well with our goal of providing patients throughout the world with access to Libervant. This announcement also aligns with our mission to put the patient at the center of everything we do. We will continue to advocate for patient access, patient choice, and patient empowerment on a global basis.”

Pharmanovia CEO, James Burt, commented, “Following a strong start to our collaboration with Aquestive Therapeutics, we’ve expanded our agreement to include many more territories. Our experience with diazepam marketed under an established brand in Valium®, combined with Aquestive Therapeutics’ unique PharmFilm® technology, provides a potentially significant delivery option to caregivers and patients in times of critical need and enables us to optimize an existing medicine to better meet the needs of patients, healthcare professionals and payors.”

Pursuant to the expanded agreement, Aquestive Therapeutics will serve as the exclusive sole manufacturer and supplier for the product and Pharmanovia will be responsible for all regulatory and commercialization activities. Aquestive will receive an undisclosed upfront payment and, if approved for market access, milestone payments, and double-digit royalties on net sales of the diazepam buccal film in the licensed territories.

About Aquestive Therapeutics

Aquestive Therapeutics, Inc. is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

Spotlight

Pharma R&D Annual Review 2023

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

More featured news

Spotlight

Pharma R&D Annual Review 2023

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

OM1 Unveils Patented, AI-powered Platform to Accelerate Personalized Medicine

businesswire | April 17, 2023

OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. PhenOM powers personalized healthcare insights at scale across the entire healthcare ecosystem, from life science research to point-of-care clinical decision making. PhenOM is an AI that gathers detailed information from large patient datasets – including unstructured clinical notes and disease activity metrics – to isolate unique patterns associated with patients with distinct characteristics. PhenOM synthesizes these patterns into unique digital phenotypes or ‘fingerprints.’ These phenotypes can be studied to inform research and deployed in real-world datasets – inside and outside OM1 – as well as in health systems and through standalone patient-facing web portals. Calibrated using OM1’s differentiated, high-quality data cloud – which is based on billions of data points from more than 300 million patients – PheonOM was built with expert clinician oversight. With an overarching mission to improve individual care and population health, the platform powers five solutions that address pain points across the healthcare system Diagnostic Insights: Finding patients with rare, undiagnosed, or misdiagnosed conditions, including subgroups of interest Treatment Insights: Personalizing treatment recommendations to improve access to care and individualizing treatment selection Risk Insights: Predicting risk of specific negative outcomes, including disease progression, complications, and catastrophic events Utilization Insights: Enabling focus on patients at risk for higher utilization, and utilization growth, over time Clinical Trial Insights: Accelerating trial startup and recruitment by identifying patients most likely to meet qualifications for enrollment, including those potentially overlooked Patient expectations over the last several years have shifted – from the adoption of virtual care and accessibility to the use of advanced technology to improve outcomes – but a persistent gap remains between population-level insights and individual patient experience: personalization. Recognizing this gap, OM1 developed PhenOM to translate patterns in large-scale data into meaningful outputs at the individual level and to better understand patient populations, diagnoses, progression, and treatment response. “Most people have now heard of the promise of AI through GPT-4, but we still have not seen many really mature, real-world clinical applications using advanced language models,” said Dr. Joseph Zabinski, Managing Director of AI & Personalized Medicine at OM1. “PhenOM is groundbreaking technology because it uses AI to translate actionable insights from our highly enriched datasets and phenotyping technology into opportunities for more personalized healthcare. This capability creates a huge potential for impact for all stakeholders, from identifying patients with under-diagnosed conditions to enabling personalized assessments of benefit for particular therapies and accelerating clinical trial enrollment.” About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

Read More

PHARMA TECH

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

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.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Accord Healthcare Expands Offerings with Generic Relapsing MS Drug

Accord Healthcare | March 14, 2023

On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping. Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and above. Its purpose is to reduce the frequency and severity of relapses, which can lead to new or worsening neurological symptoms associated with the disease. Accord Healthcare US Vice President of Sales Jim Brown stated, "We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS." He added, "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS." (Source – Cision PR newswire) Teriflunomide is an immunomodulatory medication that inhibits an enzyme critical to a metabolic pathway that supports lymphocyte proliferation. This results in fewer activated lymphocytes, which minimizes inflammation and immunological reactivity, resulting in lower recurrence rates and protection of brain volume against inflammatory nerve cell attacks. Around 2.8 million people globally have multiple sclerosis, with the majority diagnosed with relapsing-remitting MS that typically begins in their twenties or thirties. Diagnosis involves experiencing two or more attacks or relapses while maintaining stability. New or exacerbated symptoms characterize relapses, and the immune system attacks the myelin sheath surrounding nerve fibers, ultimately causing long-term damage. Symptoms include numbness, fatigue, double vision, and balance problems. Besides, relapsing-remitting MS can also progress to active secondary progressive disease. About Accord Healthcare Accord Healthcare, a subsidiary of Intas Pharmaceuticals, is recognized as a prominent player in the generic pharmaceutical industry. The company's vision is to enhance patient access to medicines and revolutionize the pharmaceutical experience for healthcare providers and patients. With an emphasis on advanced manufacturing technology and in-house research, Accord Healthcare delivers a wide range of affordable, complex, and essential medicines. The company's dedication to forward-thinking and innovative solutions remains at the core of its mission. Headquartered in Durham (North Carolina), its products are marketed in 80 countries through the Intas network.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

OM1 Unveils Patented, AI-powered Platform to Accelerate Personalized Medicine

businesswire | April 17, 2023

OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. PhenOM powers personalized healthcare insights at scale across the entire healthcare ecosystem, from life science research to point-of-care clinical decision making. PhenOM is an AI that gathers detailed information from large patient datasets – including unstructured clinical notes and disease activity metrics – to isolate unique patterns associated with patients with distinct characteristics. PhenOM synthesizes these patterns into unique digital phenotypes or ‘fingerprints.’ These phenotypes can be studied to inform research and deployed in real-world datasets – inside and outside OM1 – as well as in health systems and through standalone patient-facing web portals. Calibrated using OM1’s differentiated, high-quality data cloud – which is based on billions of data points from more than 300 million patients – PheonOM was built with expert clinician oversight. With an overarching mission to improve individual care and population health, the platform powers five solutions that address pain points across the healthcare system Diagnostic Insights: Finding patients with rare, undiagnosed, or misdiagnosed conditions, including subgroups of interest Treatment Insights: Personalizing treatment recommendations to improve access to care and individualizing treatment selection Risk Insights: Predicting risk of specific negative outcomes, including disease progression, complications, and catastrophic events Utilization Insights: Enabling focus on patients at risk for higher utilization, and utilization growth, over time Clinical Trial Insights: Accelerating trial startup and recruitment by identifying patients most likely to meet qualifications for enrollment, including those potentially overlooked Patient expectations over the last several years have shifted – from the adoption of virtual care and accessibility to the use of advanced technology to improve outcomes – but a persistent gap remains between population-level insights and individual patient experience: personalization. Recognizing this gap, OM1 developed PhenOM to translate patterns in large-scale data into meaningful outputs at the individual level and to better understand patient populations, diagnoses, progression, and treatment response. “Most people have now heard of the promise of AI through GPT-4, but we still have not seen many really mature, real-world clinical applications using advanced language models,” said Dr. Joseph Zabinski, Managing Director of AI & Personalized Medicine at OM1. “PhenOM is groundbreaking technology because it uses AI to translate actionable insights from our highly enriched datasets and phenotyping technology into opportunities for more personalized healthcare. This capability creates a huge potential for impact for all stakeholders, from identifying patients with under-diagnosed conditions to enabling personalized assessments of benefit for particular therapies and accelerating clinical trial enrollment.” About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

Read More

PHARMA TECH

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

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.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Accord Healthcare Expands Offerings with Generic Relapsing MS Drug

Accord Healthcare | March 14, 2023

On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping. Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and above. Its purpose is to reduce the frequency and severity of relapses, which can lead to new or worsening neurological symptoms associated with the disease. Accord Healthcare US Vice President of Sales Jim Brown stated, "We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS." He added, "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS." (Source – Cision PR newswire) Teriflunomide is an immunomodulatory medication that inhibits an enzyme critical to a metabolic pathway that supports lymphocyte proliferation. This results in fewer activated lymphocytes, which minimizes inflammation and immunological reactivity, resulting in lower recurrence rates and protection of brain volume against inflammatory nerve cell attacks. Around 2.8 million people globally have multiple sclerosis, with the majority diagnosed with relapsing-remitting MS that typically begins in their twenties or thirties. Diagnosis involves experiencing two or more attacks or relapses while maintaining stability. New or exacerbated symptoms characterize relapses, and the immune system attacks the myelin sheath surrounding nerve fibers, ultimately causing long-term damage. Symptoms include numbness, fatigue, double vision, and balance problems. Besides, relapsing-remitting MS can also progress to active secondary progressive disease. About Accord Healthcare Accord Healthcare, a subsidiary of Intas Pharmaceuticals, is recognized as a prominent player in the generic pharmaceutical industry. The company's vision is to enhance patient access to medicines and revolutionize the pharmaceutical experience for healthcare providers and patients. With an emphasis on advanced manufacturing technology and in-house research, Accord Healthcare delivers a wide range of affordable, complex, and essential medicines. The company's dedication to forward-thinking and innovative solutions remains at the core of its mission. Headquartered in Durham (North Carolina), its products are marketed in 80 countries through the Intas network.

Read More

More featured news