Business Insights, PHARMACY MARKET
Businesswire | August 03, 2023
MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI).
Richard Francis said1
“We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.”
“The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.”
UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales.
About LAI olanzapine (mdc-TJK), initiated in January 2023
Eric Hughes said1
“Our Olanzapine Phase 3 study is actually enrolling very quickly.”
“Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.”
Richard Francis, said1
“With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.”
mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales.
MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.
Businesswire | August 18, 2023
Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the first collaboration in the Koneksa Academic Partnership Program for Parkinson’s Disease (KAPP-PD) to incorporate its Neuroscience Toolkit into research programs.
The first collaboration of the KAPP-PD program, with Oregon Health & Science University (OHSU), enables the inclusion of app-and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments from Koneksa’s Neuroscience Toolkit into a study comparing short-acting versus long-acting levodopa in Parkinson’s disease. Koneksa’s Neuroscience Toolkit implements a variety of digital assessments that can be combined to collect data for measures of interest.
The OHSU team, led by Dr. Delaram Safarpour, MD, MSCE, FAAN, is investigating changes in the neurophysiological correlates of PD with carbidopa-levodopa immediate release compared to long-acting levodopa (Rytary), as well as changes in gait performance at intervals of 30 minutes for a total of 4 hours during each visit. This research will provide strong support for clinical profiles of short- versus long- acting levodopa in PD corresponding to objective physiological measures.
“We are collaborating with Koneksa to enhance our study’s objectives: We’ll be including smartphone- and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments into our study,” said Martina Mancini, Ph.D., co-investigator of the study, director of the Balance Disorders Laboratory, and Associate Professor of Neurology, OHSU School of Medicine. “Our lab uses new technologies to better understand and measure motor impairments, with the goal of learning how to better help patients with these conditions. Novel, objective metrics, like those made possible with Koneksa’s technology and toolkit, allow us to expand upon what we’ve been able to do in the clinic. In particular, digital at-home measures of daily physical activity, gait and mobility, motor functionality, sleep, and ePRO measures of quality of life all have the potential to uniquely complement OHSU’s in-clinic assessments, offering new and real-world-setting patient insights to support the study’s objectives.”
“Koneksa is proud to extend our contribution to critical neuroscience research through KAPP-PD, and we’re delighted to get the program underway with our first collaboration,” said John Wagner, MD, Ph.D., Chief Medical Officer, Koneksa. “These measures will support OHSU in both in-clinic and at-home patient monitoring of critical parameters of interest for this study. We’re committed to helping to get new and better treatments to patients faster, and that’s a vision that OHSU’s Balance Disorders Laboratory shares.”
About the Koneksa Academic Partnership Program – Parkinson’s Disease
The Koneksa Academic Partnership Program – Parkinson’s Disease (KAPP-PD) is a structured collaboration between Koneksa and select academic partners that enables researchers to incorporate Koneksa’s Neuroscience Toolkit into research programs focusing on Parkinson’s disease. Researchers gain access to an array of devices that capture key measures objectively and sensitively, as well as training materials for site coordinators and study subjects, a cloud-based platform for real-time monitoring, and industry-leading analytics and patented algorithms.
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes.
Businesswire | June 28, 2023
Ozette Technologies, Inc., a technology-driven life sciences company, announced its collaboration with Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers. Umoja will use Ozette’s AI-powered single-cell technology for their preclinical studies.
As part of this work, the Ozette Platform™ will be used to provide research and development (R&D) support and evaluate biomarker endpoints from preclinical tumor-bearing, humanized mouse models. Humanized mouse models are often deployed in preclinical studies as a tool for modeling human immune responses in the evaluation of potential therapeutics and treatment effects before first-in-human studies. The goal of this collaboration is to help derive insights that have the potential to catalyze Umoja’s therapeutic program development.
“Our mission is to unlock the power of the immune system using computation and machine learning. As a result, we can quickly understand how the immune system is evolving and what that means for a therapy and a patient at the single-cell level,” said Dr. Ali Ansary, CEO and Co-founder of Ozette. “This collaboration with Umoja is an important opportunity to continue showcasing Ozette’s technology and innovative impact on the vast variety of therapeutic indications, including cutting-edge T-cell treatments.”
Umoja and Ozette share a common mission to increase the efficiency of drug development and expand access to transformative immunotherapies through technology innovation. The partnership will leverage Ozette Endpoints™ and Ozette Discovery™ to enable both companies' multidisciplinary scientific and bioinformatic teams to collaborate and expand the benefits of CAR T-cell immunotherapy to patients in need.
“Our collaboration with Ozette is the next step in expanding the value of our preclinical data by leveraging their advanced single-cell technology,” said Ryan Larson, Ph.D., Senior Vice President of Translational Science at Umoja. “The Ozette Platform will allow us to efficiently distill complex biology, that traditionally relies on manual analysis, into actionable insights rapidly. Together, we’re able to gather a deeper and wider set of preclinical insights from our data which, in turn, allows us to increase the efficiency of developing our transformative therapeutics. We’re excited to expand our R&D efforts with Ozette on broader applications at Umoja.”
Ozette Technologies, Inc. is engineering a transformative leap in measuring and understanding the immune system. The Seattle-based life sciences company is building a groundbreaking high-resolution, single-cell immune monitoring platform and corpus of high-resolution data leveraging its differentiated novel ML technologies. Ozette’s Assay-to-Insights product launch combines three technologies developed by the company: world-class data generation at the Ozette Laboratory under Good Clinical Laboratory Practices (GCLP) guidelines, rapid computational monitoring of pre-defined biomarker endpoints using Ozette Endpoints™, and unbiased discovery and annotation of single-cell data through Ozette Discovery™. Insights generated from Ozette Endpoints™ and Ozette Discovery™ are made available through the Ozette Platform™, a cloud-based system that leverages automation enabling scientific teams to interact and explore their data. Founded in late 2020, Ozette was spun-out of the Fred Hutchinson Cancer Center and incubated at the Allen Institute for AI. Ozette has since published their technology in a number of journals including Nature, Science, and Cell. Ozette’s interdisciplinary team is made up of a deep bench of scientists, statisticians, engineers, and designers with a wide range of experience spanning Genentech, Google, Microsoft, Amazon, Airbnb, and more. Ozette’s team also includes leaders and pioneers in the field of medical research and single-cell analysis, including founders: physician Ali Ansary, and scientists Greg Finak, Evan Greene, and Raphael Gottardo. Ozette believes that mapping and studying the complexity of the immune system unlocks insights that accelerate research and ultimately derive better immunotherapies; we believe in better data.
About Umoja Biopharma
Umoja Biopharma, Inc. is an early clinical-stage company advancing an entirely new approach to immunotherapy. The Company is a transformative multi-platform immuno-oncology company founded with the goal of creating curative treatments for solid and hematological malignancies. Founded based on pioneering work performed at Seattle Children’s Research Institute and Purdue University, Umoja’s novel approach is powered by integrated cellular immunotherapy technologies including the VivoVec™ off-the-shelf in vivo delivery platform, the RACR™/CAR in vivo cell expansion/control platform, and the TumorTag™ targeting platform. Designed from the ground up to work together, these platforms are being developed to create and harness a powerful immune response in the body to directly, safely, and controllably attack cancer. Umoja believes that its approach can provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives.