BUSINESS INSIGHTS, PHARMACY MARKET
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.”
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.
BUSINESS INSIGHTS, PHARMA TECH
Indivior | March 06, 2023
Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl.
Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023.
OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA).
A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.
businesswire | April 03, 2023
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapeutic areas, today announced that it has entered into a platform research evaluation collaboration and option agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will use its proprietary drug-formulation platform, XeriJect™, to develop ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Xeris will receive an upfront payment and potential milestone payments for preclinical achievements. Regeneron has an option to commercially license the Xeris technology for such molecules and nominate additional molecules for reformulation and potential commercialization. Specific financial terms of the agreement were not disclosed.
“We are excited to be working with Regeneron on a platform collaboration basis, which builds on our prior feasibility studies and reflects the significant progress and investment we have been making into the development of XeriJect™,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Through our novel drug-formulation platform, we aim to provide our biologic development collaborators with the competitive advantage of delivering a significantly improved patient and provider experience through stable, ready-to-use, ultra-highly concentrated, small-volume subcutaneous injection formulations. This agreement with Regeneron is another in a series of collaborations Xeris has recently undertaken with top pharmaceutical and biotechnology companies.”
Xeris’ drug-delivery system, XeriJect, provides innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >450mg/mL, enable small volume subcutaneous injections, do not settle on storage and are ready-to-use. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.