PHARMACY MARKET
PR Newswire | October 12, 2023
Indivior PLC a leading addiction treatment company, announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000.
ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder ("OUD") patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system.
Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved.
"Alar provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD with potentially the first three-month buprenorphine LAI," said Christian Heidbreder, Chief Scientific Officer. "By providing a therapeutic option for patients who might benefit from less frequent dosing, ALA-1000 has the potential to broaden the spectrum of care for OUD treatment as well as enhance the addressable patient population."
ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose ("SAD") study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD2. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039.
Based in Taichung, Taiwan, Alar is a drug development company which focuses on developing long-acting drug products for central nervous system ("CNS") disorders and chronic diseases, utilizing its proprietary depot technology. Compared with other long-acting subcutaneous injection technologies, its proprietary platform has been associated with distinctive characteristics such as low viscosity solution, small injection volume and sustained drug release profile.
The transaction is not expected to have a material impact on the Group's FY 2023 adjusted results.
About Indivior
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder (SUD). Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in 39 countries worldwide.
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PHARMACY MARKET
Business Wire | October 10, 2023
Iambic Therapeutics a biotechnology company developing novel therapeutics from its unique generative AI discovery platform, today announced the closing of an oversubscribed $100 million Series B financing co-led by Ascenta Capital and Abingworth, and also including new investors NVIDIA, Illumina Ventures, Gradiant Corporation, and independent board member Bill Rastetter. Existing investors also participated, including Nexus Ventures, Catalio Capital Management, Coatue, FreeFlow, OrbiMed, and Sequoia Capital. As part of the Series B, Iambic is delighted to welcome two new board members, Evan Rachlin, M.D., from Ascenta Capital and Kurt von Emster from Abingworth.
“At Iambic, our world-class team has combined physics and AI to create a differentiated drug discovery platform that achieves a step-change in the speed and success rate for delivering best-in-class and first-in-class development candidates to clinic,” commented Tom Miller, Ph.D., Co-founder and Chief Executive Officer of Iambic. “With the Series B funding, we intend to advance multiple AI-discovered candidates into the clinic and expand our pipeline, demonstrating how the Iambic platform can deliver better therapeutics to patients in less time, with optimized target product profiles for greater likelihood of clinical success.”
“We were struck by the originality of these molecules, offering distinctive approaches in both deeply validated and more novel biological pathways,” added Evan Rachlin, M.D., Co-founder and Managing Partner of Ascenta Capital. “Iambic’s platform enables a more creative and expansive exploration of how to treat diseases with profound unmet needs. We are delighted to partner with Tom and his extraordinary team in translating these thoroughly tested medicines into humans.”
“Abingworth is proud to support the remarkably talented team at Iambic in its drive to revolutionize drug discovery and speed to the market with highly selective drugs,” said Kurt von Emster, Managing Partner and Head of Life Sciences at Abingworth.
“AI-driven technologies, including methods that Iambic and NVIDIA researchers have built together, are charting a new path for researchers in the discovery of new therapeutic candidates,” said Rory Kelleher, Director of Healthcare and Life Sciences at NVIDIA. “NVIDIA-accelerated computing and software are helping industry pioneers like Iambic drive scientific breakthroughs and our continued collaboration aims to speed innovation in drug discovery.”
“We believe technology innovations powered by advanced computing and omics-derived data insights will transform drug discovery and pave the way for the next wave of groundbreaking medicines,” said Ron Mazumder, Ph.D., MBA, Partner of Illumina Ventures. “Iambic’s physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time.”
Since its 2021 Series A financing, Iambic has rapidly built its AI-driven discovery platform, which unifies state-of-the-art, physics-informed machine learning and experimental automation, and has demonstrated the platform’s success in identifying therapeutic candidates with differentiated drug profiles. In addition to building out a deep bench of AI and drug-discovery experts, Iambic has discovered two candidates to advance into the clinic: IAM-H1, a highly selective and brain-penetrant inhibitor of HER2 and its oncogenic mutants, and IAM-C1, a potential first-in-class selective dual CDK2/4 inhibitor to address unmet needs in terms of therapeutic window and treatment resistance in cell-cycle-driven cancers. Further, Iambic has extended its leadership position in the AI community, creating methods such as NeuralPLexer and OrbNet to drive its discovery platform.
With the funds raised in the Series B, Iambic intends to advance multiple candidates into clinical development, expand its pipeline with additional candidates with best-in-class and first-in-class potential, and continue to innovate and build next-generation AI and automation technologies for drug discovery. It plans to leverage NVIDIA technology such as the NVIDIA DGX Cloud AI supercomputing platform and the NVIDIA BioNeMo cloud service to accelerate discovery.
The company retains the technology created under its prior name of Entos Inc., adopting the new name of Iambic Therapeutics to reflect its transition to a company with the additional capability of clinical development of candidates identified through its AI-driven discovery platform.
About the Iambic Therapeutics Physics-Informed AI-Driven Discovery Platform
The Iambic Therapeutics AI-driven platform was created to address the most challenging design problems in drug discovery, incorporating the most current AI technologies and purpose-built tools from Iambic. The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform’s algorithms enable identification of new chemical mechanisms for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and exploration of the chemical space to discover candidates for development with highly differentiated properties. Through close integration of AI-generated molecular designs with automated experimental execution, Iambic completes design-make-test cycles on a weekly cadence.
About Iambic Therapeutics
Founded in 2019 and headquartered in La Jolla, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinic with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs.
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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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