PHARMACY MARKET

Ultivue Announces Co-Marketing Agreement with Aignostics for Unique Spatial AI-Powered Imaging Solutions for Translational Medicine

Ultivue, Inc., | March 10, 2022

Ultivue, Inc., an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Aignostics GmbH, a global leader in Artificial Intelligence (AI) powered precision diagnostics focused on pathology to assist with research, clinical trials and CDx development, announced a partnership to collaborate on the co-development of AI-powered spatial multiplexed immunophenotype solutions for translational research groups and Biopharma.

The companies have already been working together since early 2021 to adapt Aignostics’ client platform to support visualization and analysis for some of Ultivue’s products and services, as well as provisioning of results and corresponding reports. The resulting co-developed platform will now be made available to joint clients. Additionally, proof of concept work conducted on the Ultivue 12-plex Immunophenotyping biomarker panel in over 1,000 clinical NSCLC cases has demonstrated encouraging results for the capacity of AI-based analysis of multiplexed images for more consistent and reproducible readouts at scale. These results will be published later this year and respective AI models made available via the platform.

The companies are now expanding their relationship under a co-marketing agreement to offer the multiplex immunofluorescence (mIF) platform to their respective biotech and pharma clients, initially for research use, with a GCP-compliant version to follow later this year. Moreover, Ultivue and Aignostics will offer AI-powered image analysis services within the platform via Aignostics “Explainable AI” approach for the consistent and precise analysis of mIF cohorts at scale, for both translational research and clinical trial research services in Ultivue’s CLIA accredited clinical research laboratory. “We are excited to extend our workflow offering to include mIF AI for highly automated image analysis by partnering with Aignostics,” says Florian Leiss, VP Digital Health at Ultivue. “Improved viewing capabilities enable us to interactively explore the interplay of mIF-labeled cell populations in the histological context of same-slide H&E.”

We believe that development of Ultivue’s assays with our AI-powered image analysis will create insights from data at scale that are unprecedented in spatial biology today. We are excited to start offering this approach to our clients for translational science and clinical trials,” 

Viktor Matyas, CEO of Aignostics

Besides offering research and development services to its clients, Ultivue and Aignostics will also develop products for standardized analysis of certain Ultivue products, paving the way for more widespread use of these technologies in both clinical trials and clinical routine.

About Ultivue
Ultivue provides researchers and scientists in translational medicine with multiplex biomarker assays for tissue phenotyping and digital pathology. Its proprietary InSituPlex® technology enables advanced exploration and interrogation of tissue samples for precision medicine research. These highly customizable solutions coupled with our scientific consultative approach strengthen and accelerate biomarker discovery and drug development programs. 

About Aignostics
Aignostics, a Berlin based company with offices in the US, is a digital pathology company dedicated to novel precision diagnostics through the use of a proprietary “Explainable AI” platform in pre-clinical and translational research and clinical trials. The use of such technology is expected to be crucial to implementation of AI-powered algorithms in routine diagnostics in order to verify (explain) the model’s decision outputs. Additionally, through its close alignment to Charité and TU Berlin amongst other collaborators, only Aignostics offers the combination of data access, sample testing and pathology expertise to develop digital pathology algorithms spanning multi-modal biomarker assay detection systems such as H&E, IHC and mIF, amongst others.

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BUSINESS INSIGHTS

Ankura Launches Pharmaceutical Data Integrity Solution

Ankura | March 09, 2022

Ankura Consulting, LLC a leading global expert services and advisory firm announced the expansion of its Pharmaceutical and Biopharma Regulatory Compliance offering with the addition of a Pharmaceutical Data Integrity solution within the Data and Technology practice, bolstering its comprehensive client advisory capabilities. With this solution, Ankura has enhanced its team of experts to support pharmaceutical clients' compliance with the Data Integrity guidelines of multiple regulators through advanced digital technology. The offering includes Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, and import alert. "In the endeavour to embrace industry 4.0, the pharmaceutical industry should explore giving up manual and fragmented means of managing compliance procedures and implement digital technologies in the quality control laboratories to proactively identify any data integrity (DI) gaps in real-time. EWS enables this transition and allows for early identification of any anomaly, falsification activities, and DI deviations from a regulatory compliance perspective," Amit Jaju, Senior Managing Director in Ankura's Data & Technology practice The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organization. "The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organizations to gain back the trust of regulators once breached. Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity," said Paul Walker, Senior Managing Director in Ankura's Data & Technology practice. In light of this, Ankura's Data Integrity investigation and remediation offering is a pivotal tool to support clients in performing comprehensive data integrity analysis using big data and advanced analytical approach on 100% of the data as compared to the sample manual review approach followed in the industry." About Ankura Ankura Consulting Group, LLC is an independent global expert services and advisory firm that delivers services and end-to-end solutions to help clients at critical inflection points related to change, risk, disputes, finance, performance, distress, and transformation. The Ankura team consists of more than 1,700 professionals serving 3000+ clients across 55 countries who are leaders in their respective fields and areas of expertise. Collaborative lateral thinking, hard-earned experience, expertise, and multidisciplinary capabilities drive results and Ankura is unrivaled in its ability to assist clients to Protect, Create and Recover Value.

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PHARMACY MARKET

Medison Pharma Announces Extension of Multi-territorial Agreement with Immunocore and Expansion into Australia and New Zealand

Medison Pharma | May 30, 2022

Medison Pharma a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced the addition of new markets to its multi-territorial agreement with Immunocore Holdings plc a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. The multi-territorial agreement to help seek regulatory authorization and commercialize Immunocore's KIMMTRAK® for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma that affects the eye, which covers Canada, twenty markets across Central Eastern Europe and Israel, will now extend to Australia and New Zealand. KIMMTRAK has been approved by both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where it is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma. "We are delighted to deepen our partnership with Immunocore and proud to further grow the reach of their breakthrough treatment, as part of our mission that knows no borders. We believe that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies. By adding new countries and continents, we are continuing in our efforts to turn our mission into a reality." Meir Jakobsohn, Founder and CEO of Medison "It can be challenging for biotechs to commercialise in a large number of countries, often resulting in delayed access to highly innovative therapies in many areas of the world. Medison's global platform is designed to address this challenge," said Gil Gurfinkel, VP Corporate Development at Medison. "Immunocore's novel therapy for unresectable or metastatic uveal melanoma and our ability to treat patients suffering from this rare and aggressive form of cancer in additional countries is a win-win outcome of our partnership." Medison's expansion of its commercial presence to Australia and New Zealand is the latest addition to its geographic growth, enabling Medison to capitalize on growing market opportunities for its commercial partners. Medison is further enlarging its footprint in Europe with a new office location for its international headquarters in Zug, Switzerland, and operations in Greece and Cyprus, which enlarge its European offering of Central Eastern Europe, the Baltic states, and Balkans. In Canada, the team is also growing and recently moved into larger office space in downtown Toronto. With this latest growth, Medison increases its commercial presence across 25 locations around the world. Medison is hiring across all locations and in key functions. About Medison Pharma Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. About KIMMTRAK® KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. KIMMTRAK is currently approved in 31 countries, including the United States and European Union.

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BUSINESS INSIGHTS

Omnicell Completes Acquisition of ReCept

Omnicell, Inc. | December 30, 2021

Omnicell, Inc. a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. This total solution supports on-site management, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care. “ReCept’s specialty pharmacy management services capabilities naturally complement Omnicell’s intelligent infrastructure, giving us deeper expertise to address the growing market need for managing complex specialty medications as part of a broader, more comprehensive medication management strategy,” Randall Lipps, chairman, president, CEO, and founder of Omnicell Under the terms of the purchase agreement, the acquisition price was $100 million, subject to customary adjustments, as provided for in the agreement and plan of merger. The ReCept business that is being acquired recorded annual recurring revenue of $24 million (unaudited) for the 12 months ended September 30, 2021, and is expected to accelerate Omnicell’s Advanced Services revenue growth. Omnicell used cash on its balance sheet to fund the transaction, which is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023. About Omnicell Since 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions.

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BUSINESS INSIGHTS

Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. | June 27, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function. “Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors (AChEIs, e.g., donepezil), and explore fosgonimeton’s effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. “The study was intended to show differences on the biomarker ERP P300 latency. This primary endpoint was not met by protocoled analysis, however a pre-specified subgroup analysis indicated a potential diminished effect of fosgonimeton when given in combination with AChEIs. A subsequent post hoc analysis of the data from patients on fosgonimeton monotherapy showed a meaningful improvement in both ERP P300 latency and cognitive performance compared to placebo at 26 weeks. “These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study,” Dr. Moebius “The data from the fosgonimeton monotherapy analysis are encouraging and show biologic activity that may support the potential role of the HGF/MET pathway in neurodegenerative diseases,” said Marwan Sabbagh, M.D., FAAN, professor of neurology at Barrow Neurological Institute, Phoenix, AZ. “ACT-AD adds to the body of literature suggesting ERP P300 latency as an important biomarker for cognitive status.”

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Confusion surrounding the legalization of cannabis and its use for medical purposes can make it difficult to understand if cannabis use is safe and legal in your area. According to Canadian law the use of cannabidiol derived from cannabis is legal under the Access to Cannabis for Medical Purposes Regulations. That means you can legally and safely choose to use cannabis products to assist with a number of medical issues.

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