Regeneron and Vyriad to develop oncolytic virus therapies

Pharmaceutical Technology | November 07, 2019

Regeneron Pharmaceuticals has formed a five-year alliance with Vyriad for the development of oncolytic virus-based treatments for cancer. Under the research collaboration and option licensing agreement, a clinical trial is set to be initiated next year to assess Regeneron’s Libtayo (cemiplimab-rwlc) in combination with Vyriad’s Voyager-V1. The trial will enrol patients with various cancer types including lung, liver and endometrial cancers, as well as melanoma. Libtayo is a PD-1 inhibitor, while Voyager-V1 is an oncolytic virus. Regeneron invented Libtayo using its VelocImmune technology, which involves the use of a genetically-humanised mouse to generate fully-human antibodies. The drug is being developed in alliance with Sanofi. Vyriad programmed Voyager-V1 to selectively attack cancer cells and also stimulate the immune system to destroy local and distant cancer cells. The oncolytic virus also boosts inflammatory and antitumor immune system responses for turning ‘cold’ tumours ‘hot’, which is believed to improve anti-PD-1 activity.

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PHARMACY MARKET

ICON selected by BARDA to conduct anthrax vaccine clinical trial

ICON plc | October 07, 2022

ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial. BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance. ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations. “We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.” Edward Wright, President, ICON Government and Public Health Solutions This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023. BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development. Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores. Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics. About ICON plc ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022. About ICON Government & Public Health Solutions ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts. About BARDA’s Medical Countermeasures Clinical Studies Network (CSN) The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.

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PHARMA TECH

ArisGlobal Accelerates Growth Announces Executive Evolution

ArisGlobal | September 08, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today announces an expansion to its C-suite. James Jarrett is the company's new Chief Financial Officer, Kathleen Turland joins as the first Chief Legal Officer, and Aman Wasan has stepped into the new role of Chief Commercial Officer. The three appointments are happening during a time of significant momentum for ArisGlobal, which has experienced annual recurring revenue growth of 34% in the first half of 2022 YoY. James Jarrett, Chief Financial Officer Jarrett brings over a decade of executive leadership experience driving revenue and cash flow growth. He has partnered with management teams and boards of directors of high-growth, highly leveraged companies undergoing rapid change. Prior to joining ArisGlobal, he served as the CFO for Emergence Health Holdings, Carewell Urgent Care, and ProCure Proton Therapy Center. Kathleen Turland, Chief Legal Officer Turland is a global strategic leader with more than 20 years of legal experience. She brings her broad range of legal and business skills to ArisGlobal, having worked with companies experiencing significant growth and expansion over the years, including General Electric, and FUSE Group. She started her legal career in New York, clerking for a Federal Court Judge, and working at two revered New York law firms. Aman Wasan, Chief Commercial Officer Wasan is an expert in general management and commercial leadership with a deep understanding and knowledge of drug safety and clinical research. Since joining ArisGlobal in 2018, Wasan has excelled in six different positions, most recently as Senior Vice President of Global Commercials, where he managed global enterprise business. Before joining the ArisGlobal team, Wasan worked for Bioclinica as the company's Global Head of Safety and Regulatory Services. "As we continue scaling our business and building new functions to better serve our customer base, expanding our C-suite will help us execute our mission and further drive our success in the life sciences industry. James, Kathleen, and Aman carry a wealth of industry knowledge instrumental in empowering ArisGlobal to further expand its customer pipeline, continue to develop innovative technology, and maintain a role as a trusted leader in the market." CEO Mike Gordon Turland's addition to the company also represents consistent and focused efforts by ArisGlobal to continually put women in positions of leadership. Turland joins ArisGlobal veterans Ritu Shrivastava, Vice President Corporate Development, and Heidi Hattendorf, Vice President of Marketing, on the executive team. Currently, ArisGlobal also has women in core leadership positions across business, product, quality, people, and technology functions. About ArisGlobal ArisGlobal is led by passionate individuals who support life sciences leaders in developing and monitoring breakthrough medicines and therapies. With more than 35 years of expertise in the life sciences industry, ArisGlobal develops technology products within the platform LifeSphere to power pharmaceutical and biotech research and development. Building on our commitment to corporate social responsibility and sustainability initiatives, we give back to the communities where we live and work – in the U.S, Europe, India, Japan, and China.

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BUSINESS INSIGHTS

Teva Announces Unique Collaboration with HealthSnap to Expand the Reach of its Respiratory Digital Health Platform

Teva Pharmaceuticals | November 21, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with HealthSnap, a leading full-service Virtual Care Management Platform for chronic disease management. The collaboration will enable more consumers to have access to Teva’s Digihaler® system, a digital health platform designed to enable patients to have more informed treatment discussions with their healthcare providers through personalized care. The collaboration will enable healthcare providers to better integrate patient data into their workflows, supporting proactive remote care across large populations. The platform can be used to monitor and manage large populations by a network of health systems. It can capture objective and actionable data for asthma patients, thereby creating the mechanism for personalized care. “Digital health platforms will succeed only by seamlessly integrating multiple data sources into workflows and systems like electronic medical records (EMR). We believe in building an ecosystem and are delighted to partner with HealthSnap as we seek to expand the reach of our platform, and continue to shape digital therapeutics and the integrated care landscape,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “We believe that the future of healthcare is in predictive and preventative care, which is a significant paradigm shift from the standard of care today. That is why we will focus our collaboration and our services on facilitating this change, to help providers deliver better care and help patients manage their condition.” “With a rich heritage of delivering innovative medicines, alongside technology development capabilities, Teva is uniquely positioned to help the healthcare ecosystem move toward greater integration of objective health data, and create meaningful population-scale solutions to help patients and providers. We envision broad utilization of our platform by consumers, healthcare providers and other technology organizations. In respiratory care, our long-term vision is ambitious and clear: harnessing the power of technology and therapeutics to predict asthma attacks.” Montalvo continued, “Over the past few years, through a talented and continuously evolving in-house team we have built a robust technology arm within Teva to continue exploring ways to improve patient outcomes. Through our vision for connected therapy, we strive to be at the nexus between patients, healthcare providers, technology, and the future of medicine, exploring new ways for digital health to serve as an economically sustainable solution for small and large healthcare provider organizations, offering timely, data-driven solutions to benefit patients. Our hope is that by working with HealthSnap and other capable companies in this space, we will fulfill our mission of improving the lives of patients, and do so by improving the health and effectiveness of our healthcare system – and we’re just getting started.” “By partnering with Teva, HealthSnap is expanding its reach to patients with respiratory diseases, allowing them to receive personalized care based on their data. HealthSnap is continuously seeking partnerships and we look forward to delivering quality at home programs with this new and exciting collaboration with Teva,” Samson Magid, Co-Founder and CEO of HealthSnap About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com About Teva Digital Health Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform Digihaler® – developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S., and with plans to expand to Europe in 2023. About HealthSnap HealthSnap is an integrated Virtual Care Management Platform that helps healthcare organizations improve patient outcomes, reduce utilization, and diversify revenue streams. From chronic disease-agnostic Remote Patient Monitoringand Chronic Care Management to AI-guided care coordination, virtual care delivery, automated care management billing, population analytics - and so much more, HealthSnap is the simplest way to manage chronic conditions remotely.

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BUSINESS INSIGHTS

Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film

Aquestive Therapeutics, Inc. | August 31, 2022

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, announced today that the U.S. Food & Drug Administration has granted tentative approval for Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. "Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco®, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. As a result of the FDA determination, the Agency cannot give final approval for Libervant until the expiration or inapplicability of the orphan drug market exclusivity, including, for example, by court order, a selective waiver of the orphan drug exclusivity, or a reversal of the FDA’s decision and determination that Libervant is “clinically superior” to Valtoco. “The FDA’s decision provides welcome clarity to our business. The tentative approval of Libervant is a significant achievement that brings us one step closer to bringing this important medicine to patients who are unable or choose not to use the current standards of care. Libervant has the potential to offer these patients a treatment option that is simple, portable, and precise. A significant unmet need exists for additional alternate delivery options given the ongoing shortage of diazepam rectal gel, which continues to represent a substantial portion of the current diazepam rescue market. This FDA action further validates our ability to gain FDA approval of our pipeline programs. We look forward to continuing the rapid progression of AQST-109 for the treatment of severe allergic reactions, including anaphylaxis, towards a filing with the FDA.” Daniel Barber, Chief Executive Officer of Aquestive “We continue to examine the FDA’s determination on Libervant market access and plan to request a meeting with the Agency as soon as possible. We disagree with the FDA’s determination on the various points presented by the Agency and believe that, particularly in the case of our submitted studies on the effect of food on the absorption of diazepam formulations, Libervant has the distinct advantage of being able to be readily administered when needed without regard to food, providing an important benefit to patients. This is important to patients as rapid and extensive drug absorption is critical in a rescue situation. We will continue to vigorously engage with the FDA on the need for these data to be carefully considered.” During the review process, the Company submitted to the FDA the results of a 2021 Aquestive sponsored randomized, open-label, two-sequence, two-period, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of Valtoco in healthy adult subjects. The results of this study indicated that, when Valtoco is administered after a high fat meal, the maximum drug concentration (Cmax) was reduced by 48% compared to Valtoco administered to subjects in a fasted state. The study also showed that the time to maximum drug concentration (Tmax) of Valtoco doubled from 2 hours to 4 hours when administered after a high fat meal. Aquestive provided the data along with a cross-study comparison to a similar study performed with Libervant, to FDA during the review process. The FDA’s decision concluded that the information Aquestive submitted was not sufficient to overturn the Agency's previous conclusion regarding the lack of food effect for Valtoco. Specifically, the FDA stated that “[a] cross-study comparison is not considered [by the reviewer] to be a suitable approach for making a quantitative comparison of plasma concentrations between different products because of the lack of a common reference standard between the two studies.” Aquestive will seek to gain alignment with the Agency on a reasonable path to appropriately characterize the food effect of Valtoco including potentially conducting a comparative study as indicated by the FDA. About Libervant Libervant™ is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. Approximately 1.0 million patients with epilepsy suffer from uncontrolled refractory seizures, approximately 85% of whom will not interact with the available treatments. 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 on the U.S. market, four licensed products and one stand-alone proprietary product to date, Sympazan® (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut syndrome. Our licensees market their products in the U.S. and around the world. 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, or CNS, and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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BlockRx is a series of initiatives presented by iSolve, a privately owned Blockchain solution provider for the Life Sciences Industry. The mission of BlockRx is to interconnect systems that do not readily communicate, establish data provenance that satisfies regulatory and business requirements, and create a network of trading partners that are incentivized to facilitate the transfer of information within a secured environment.

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