Entyvio beats Humira in head-to-head ulcerative colitis trial

PharmaTimes | September 27, 2019

Takeda has unveiled further data from the VARSITY study showing the superiority of the gut-selective biologic Entyvio (vedolizumab) to the anti-tumour necrosis factor-alpha (anti-TNFα) biologic Humira (adalimumab) in achieving clinical remission in patients with ulcerative colitis (UC). Results of the trial, published in The New England Journal of Medicine (NEJM), show clinical remission rates in patients with moderately to severely active UC of 31.3% for Entyvio and 22.5% for Humira after 52 weeks' treatment. Entyvio achieved higher percentages of clinical remission at week 52 compared to Humira in both anti-TNFα-naïve patients (34.2% versus 24.3%, respectively) and anti-TNFα-experienced patients with UC (20.3% versus 16.0%, respectively). Also, in the secondary endpoints of the study, treatment with Entyvio was linked with significantly higher percentages of mucosal healing at week 52 compared to patients treated with Humira (39.7% versus. 27.7%). However, Takeda's drug was not found to be superior to in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52 (12.6% versus 21.8%).

Spotlight

The rising cost of pharmacovigilance (PV) tasks has been an ongoing challenge for the pharma industry. Many companies have chosen to shift these tasks to overseas vendors to take advantage of cheaper labor without compromising quality.

Spotlight

The rising cost of pharmacovigilance (PV) tasks has been an ongoing challenge for the pharma industry. Many companies have chosen to shift these tasks to overseas vendors to take advantage of cheaper labor without compromising quality.

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BUSINESS INSIGHTS

Stevanato Group and Gerresheimer AG Announce Collaboration on the Development of an Innovative Ready-To-Use Vial Platform

Gerresheimer and Stevanato Group | September 08, 2022

Stevanato Group S.p.A. a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announce that they have jointly developed a high-end Ready-To-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s market-leading EZ-fill® technology. This collaboration is projected to help customers gain efficiencies, improve the quality standard, increase speed to market, reduce total cost of ownership (TCO) and help mitigate supply chain risk. Stevanato Group and Gerresheimer AG are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The collaboration aims to make RTU vials a standard, available to a wide number of pharma companies globally – offering premium quality solutions to patients and reducing complexity for pharma operations. The new solution will be available to other players in the market to standardize fill-finish operations from early phase drug development to commercialization. The new RTU solution platform from Stevanato Group and Gerresheimer AG will share the same secondary packaging, production process and sterilization method, ensuring consistent available capacity and a reliable double sourcing to the pharmaceutical industry. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. In addition, customers can count on a high-end solution made by two major players in the drug containment industry with a long history of innovation. The new jointly developed vial platform and trademark will be presented in detail to the market at the CPhI Worldwide in Frankfurt in November 2022. “Our EZ-fill® vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and value for Pharmaceutical Companies and CMOs. Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill® vials already underway in the market.” Mauro Stocchi, Chief Business Officer at Stevanato Group “The new developed RTU vial platform stands out in terms of quality, TCO and sustainability and takes the use of RTU solutions like vials and, in the future, cartridges to a new level,” said Dr. Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. "Due to the strong reduction of the particle load, the quality is significantly increased. Our new innovative solution will convince the market to significantly accelerate the conversion from bulk to RTU vials.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. About Gerresheimer AG Gerresheimer AG is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the commercial product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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BUSINESS INSIGHTS

BC Platforms Partners with EU Funded, AI-Driven, Cancer Data Initiative

BC Platforms | November 25, 2022

BC Platforms a global leader in healthcare data management and analytics announced that it has been chosen as key partner in a European Commission project. Under the EC's Horizon Europe program*, Helsinki University Hospital has been awarded a contract to lead a EURO 7 million consortium project termed ONCOVALUE. BCP will work closely with HUS as a key delivery partner in this major EC project. ONCOVALUE is an Artificial Intelligence-based framework which assesses, in real-time, real-life effectiveness of novel cancer therapies. It does this by standardising data processing in hospitals enabling them to efficiently measure the cost effectiveness of new cancer therapies for Health Technology Assessment (HTA) and regulatory purposes. BCP will aid in core aspects of the project, including creating the technical architecture and providing the data analysis, to ensure this technology can transform unstructured patient data from medical notes and images into structured data and real-world evidence (RWE) that clinicians can use in treatment management and with health regulatory and HTA bodies "This latest partnership with ONCOVALUE is part of our rapidly expanding Trusted Collaborative Environment solution. I'm proud our sophisticated healthcare data management and analytics products have been recognised by this significant, four-year, Horizon Europe project. By opening the door to widespread regulatory and HTA integration of real-world data, ONCOVALUE should lead to better, more environmentally sustainable therapies, technologies, and digital solutions for cancer care." Tero Silvola, CEO of BC Platforms Johanna Mattson, HUS's Senior Medical Director in Oncology, said, "ONCOVALUE aims to develop novel AI-based tools to automate the collection and analytics of clinical data. This will contribute to the increased cost-effectiveness and sustainability of European cancer care. Systematic collection and evaluation of patient reported outcomes should lead to improved health and well-being and should reduce the growing global burden of cancer treatment." The ONCOVALUE consortium is made up of eleven institutions and companies in Finland, The Netherlands, Denmark, Portugal, and Italy. Over the four-year project span, annually around 40,000 European patients will participate from hospitals in the consortium. About BC Platforms BC Platforms is a global leader in building data networks for the life sciences industry and provides versatile technology platforms for personalised medicine, accelerating the translation of innovations into clinical practice. We convert complex biological information collected in the healthcare setting into actionable insights. With our innovative technology we are creating a patient centric infinity loop between the life sciences and healthcare sectors. Data we generate, harmonise, and manage, from diverse biobanks and healthcare institutions, is made accessible for pharmaceutical and biotech companies to enhance their core strengths in research and development. In parallel, we enable stratification of patients towards targeted therapies, delivering on the promise of more personalized healthcare.

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PHARMACY MARKET

Walgreens Boots Alliance Completes Majority Share Acquisition of CareCentrix

Walgreens Boots Alliance and CareCentrix | September 01, 2022

Walgreens Boots Alliance, Inc. announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care. By bringing together Walgreens trusted health services and community presence with CareCentrix’s technology-enabled, care-at-home solutions, the partnership better addresses the needs of people with complex or chronic conditions as they transition out of the hospital. CareCentrix’s advanced data analytics capabilities enable highly personalized care plans to help people transition to the right site of care, prioritizing care in the home when appropriate. This approach supports both care quality and value by reducing hospital readmissions and improving patient satisfaction and outcomes. “We created Walgreens Health to reimagine local healthcare and wellbeing for all. This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it.” Roz Brewer, CEO, WBA Healthcare services delivered after discharge, including care delivered in the home, are one of the fastest growing segments in healthcare today. Caring for patients from the hospital to the home represents more than $75 billion in annual healthcare costs for payers, providers and patients. “The most challenging part of the healthcare journey is the last mile – extending healthcare delivery into people’s homes,” said John Driscoll, CEO, CareCentrix. “Together with Walgreens Health, CareCentrix is able to combine Walgreens trusted community presence with our powerful technology-enabled care to better address patients’ unique health needs in their homes.” In addition to home-based care, CareCentrix connects patients to appropriate providers and sites of care post-discharge, utilizing a predictive analytics platform, HomeFirst Analytics. This level of customization also includes pairing patients with care transition teams that support patient engagement for 90 days post-discharge to improve quality metrics. Walgreens Health will continue to advance capabilities that integrate CareCentrix data analytics and home care expertise with WBA’s portfolio of health solutions to identify and close care gaps, as well as coordinate patient care across conditions, settings and provider networks. These capabilities will enable Walgreens to support medication reconciliation for CareCentrix patients transitioning from hospital to home and provide primary care options to patients when needed, including Village Medical physicians and advanced practice providers. CareCentrix will also play a critical role in Walgreens Health integrated offerings to manage population level risk for benefits management and post-acute spend and outcomes. CareCentrix manages care for 19 million members through approximately 7,400 provider locations, and empowers more people to live, heal and age at home. By partnering with health plans and health systems, CareCentrix has reduced total cost of care for members by 20 percent, including a greater than 11 percent reduction in emergency department usage and a 23 percent reduction in skilled nursing costs. This investment gives WBA majority ownership of CareCentrix, investing approximately $330 million for 55 percent of the company at an $800 million valuation, net of debt, with the option to acquire the remaining equity interests in the future. In WBA’s fiscal year 2021, CareCentrix delivered pro forma sales of $1.5 billion. Following the completion of the investment, CareCentrix will continue to operate as an independent company under its current executive leadership. Sidley Austin LLP acted as lead legal advisor for WBA, along with Weil, Gotshal & Manges LLP. Citi acted as financial advisor for CareCentrix, Inc., and Cleary Gottlieb Steen & Hamilton LLP acted as lead legal advisor. About Walgreens Boots Alliance Walgreens Boots Alliance is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 170-year heritage of caring for communities. A trusted, global innovator in retail pharmacy with approximately 13,000 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. The company is reimagining local healthcare and well-being for all as part of its purpose – to create more joyful lives through better health. Through dispensing medicines, improving access to a wide range of health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare. WBA has more than 315,000 team members and a presence in nine countries through its portfolio of consumer brands: Walgreens, Boots, Duane Reade, the No7 Beauty Company, Benavides in Mexico and Ahumada in Chile. Additionally, WBA has a portfolio of healthcare-focused investments located in several countries, including China and the U.S. About CareCentrix CareCentrix offers value-based home solutions to payors and health systems to help more of their members access the home care they need, when they need it. Through a single platform, CareCentrix coordinates multiple, complex home care needs for over 19 million members through a national network of approximately 7,400 provider locations, resulting in a simplified patient and physician experience. For over 25 years, CareCentrix’s focus on the whole person has improved continuity of care, reduced unnecessary readmissions and unnecessary emergency department utilization, and has delivered positive financial results for health plans. With proprietary HomeFirst Analytics to stratify risk and optimize care delivery, CareCentrix takes on the complexities of care coordination and management of care in the home to provide our clients with essential insights into care at home. CareCentrix has been named one of Fierce Healthcare’s 2022 “Fierce 15” companies and FORTUNE’s Best Workplaces for Aging Services.

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