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

UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31st EADV Congress

UCB, Inc. | September 02, 2022

UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases. "We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA). For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB).

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BUSINESS INSIGHTS

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

Iterative Scopes | September 23, 2022

Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The device was evaluated in the largest U.S.-based multicenter clinical study for a computer aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.1 In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations. Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26%4 – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5 “Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes. We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care.” Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes SKOUT is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.1 These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so. “Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.” “We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions,” said Daniel Hamburger, CEO at Provation. “SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care.” SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal. About Iterative Scopes Iterative Scopes is a pioneer in the application of artificial intelligence-based precision medicine for gastroenterology with the aim of helping to optimize clinical trials investigating treatment of inflammatory bowel disease (IBD). The technology is also designed to potentially enhance colorectal cancer screenings. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to impact polyp detection for colorectal cancer screenings and working to standardize disease severity characterization for inflammatory bowel disease. Longer term, the company plans to establish more meaningful endpoints for GI diseases, which may be better predictors of therapeutic response and disease outcomes. Spun out of MIT in 2017, the company is based in Cambridge, Massachusetts. About Provation Provation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation’s comprehensive portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation anesthesia documentation patient engagement, surgical care coordination, quality reporting, and billing capture order set and care plan management and EHR embedded clinical documentation. Provation has a loyal customer base, serving more than 5,000 hospitals, surgery centers, and medical offices, and 700 physician groups globally, including 19 of the top 20 U.S. hospitals. In 2021, Provation was acquired by Fortive Corporation, a Fortune 1000 company that builds essential technology and accelerates transformation in high-impact fields like workplace safety, engineering, and healthcare.

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BUSINESS INSIGHTS

DisperSol Appoints Tim Scott New President and CEO; Company Changes Name to AustinPx™, Pharmaceutics and Manufacturing

AustinPx | August 29, 2022

DisperSol Technologies, LLC, a specialty pharmaceutical company announced the appointment of Tim Scott as president and chief executive officer of the company. At the same time, the company announced that it is changing its name to AustinPx™, Pharmaceutics and Manufacturing, to better reflect the company’s new direction as a contract development and manufacturing organization. Mr. Scott also joins the board of directors of AustinPx. The hiring of Mr. Scott and the company name change to AustinPx, Pharmaceutics and Manufacturing, are part of a shift in the focus of the pharmaceutical technology company that first developed KinetiSol® technology, a patented amorphous dispersion technology for improving drug bioavailability. The company will now provide pharmaceutical chemistry services including analytical and formulation development and cGMP manufacturing at its site in Austin, Texas. Mr. Scott was the co-founder and president of Pharmatek Laboratories from 1999 until 2016, when he sold the company to Catalent Pharma Solutions (NYSE: CTLT). He currently serves as board chair of Biocom, a trade organization supporting 2,000 life science companies. Mr. Scott also serves on the Medical Research Advisory Committee for the Conrad Prebys Foundation, providing grants to innovative research in the health sciences. “I can think of no one better to lead the transformation of AustinPx than Tim. He brings a wealth of experience in building a contract development and manufacturing business, and he has strong connections throughout the industry. We are delighted to have his leadership as we build AustinPx into a world class CDMO.” Shaun Kirkpatrick, President at Research Corporation Technologies and board chair of AustinPx “Our goal is to build a client-centric organization that provides drug development and manufacturing services for pharma companies worldwide,” says Scott. “The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic, which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol, a truly next generation technology for rendering active pharmaceutical ingredients amorphous.” KinetiSol is a proprietary technology for improving drug bioavailability. This advanced technology transforms active pharmaceutical ingredients into amorphous solid dispersions, thereby enhancing the physiochemistry and PK of drugs. KinetiSol offers many advantages over other amorphous dispersion technologies. It provides a broader formulation design space and a more efficient scale-up. Additionally, KinetiSol’s significantly smaller ecological footprint makes it a greener technology. About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. The company specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules – including its next generation amorphous dispersion platform, KinetiSol®. AustinPx’s lead investors include Research Corporation Technologies, Inc. and Acadia Woods.

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PHARMACY MARKET

ICON selected by BARDA to conduct anthrax vaccine clinical trial

ICON plc | October 07, 2022

ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial. BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance. ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations. “We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.” Edward Wright, President, ICON Government and Public Health Solutions This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023. BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development. Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores. Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics. About ICON plc ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022. About ICON Government & Public Health Solutions ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts. About BARDA’s Medical Countermeasures Clinical Studies Network (CSN) The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.

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