PHARMACY MARKET
Business Wire | September 28, 2023
Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support.
Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization.
“The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.”
“Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.”
About Cytel
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia.
About co.faktor
For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.
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PHARMACY MARKET
GlobeNewswire | September 12, 2023
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 acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024.
Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027.
“The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”
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 (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. 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. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access.
About Aquestive
Aquestive 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.
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PHARMACY MARKET
Business Wire | October 17, 2023
BioMap announced a groundbreaking strategic collaboration with Sanofi to co-develop cutting-edge AI modules for biotherapeutic drug discovery leveraging BioMap’s AI platform.
“As the largest foundational model-based approach within life sciences, we are thrilled to collaborate with Sanofi and leverage the potential of BioMap’s cutting-edge AI engine to help solve complex problems associated with new protein therapies to drive drug discovery,” said BioMap’s Chief Technology Officer, Le Song. “We have built what is essentially a biological map of proteins using data sets from public and private sources to inform our foundational models. Utilizing automation and integrated workflows to enhance the collection of high-quality data, we can catalyze the process of new hit discovery and lead optimization.”
Traditional AI methods require vast amounts of labeled data to make accurate predictions. However, in life science, labeled data are often in short supply. BioMap’s foundational models are revolutionizing AI in biology by enabling one large model, trained on ubiquitous unlabeled data, to inform multiple downstream task models. This approach enables superior prediction from limited data in a range of therapeutic areas, including immunology, neurology, oncology, and rare diseases.
Leveraging BioMap’s custom-built foundational models and world-leading AI expertise, as well as Sanofi’s proprietary data, computational innovations in protein engineering, and deep biologics development experience, both parties aim to create advanced AI models and protein Large Language Models that will enable biologics design and multiparametric optimization.
"By combining Sanofi’s proprietary data sets, digital infrastructure, AI and data science capabilities, and drug development expertise with BioMap’s protein Large Language Models, high-performance computing, and deep understanding of AI, we can optimize the process of discovery and development of breakthrough biotherapeutics,” said Matt Truppo, Global Head of Research Platforms at Sanofi. “Our collaboration with BioMap further underscores Sanofi’s commitment to becoming the first pharma company powered by artificial intelligence at scale.”
Under the terms of the agreement, BioMap will receive an upfront cash payment and near-term payments for reaching module development milestones from Sanofi. BioMap will be eligible to receive payments of over $1 billion based on achievement of pre-clinical development, clinical development, regulatory, and commercial milestones.
About BioMap
Founded in 2020 by Robin Li and Wei Liu, BioMap is a disruptive life science AI company responsible for building xTrimo, the first and largest protein-centric large language model platform. Their technology allows scientists to model life more accurately, from proteins to a system level, and extract novel insights and predictions from limited data. Supported by an international, cross-functional team of over 300 experts, BioMap is solving critical, protein-related drug development problems and charting a course to radically improve patients’ lives.
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