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

In 1992, with the support of the biopharmaceutical industry, Congress created the 340B Drug Discount Program to help uninsured and vulnerable patients gain access to affordable prescription drugs. As part of the law, drug manufacturers provide discounts on outpatient medicines and treatments to select health care entities  often referred to as safety-net providers. The program was necessitated by changes to the Medicaid program that precluded drug makers from continuing to offer steep discounts to safetynet providers voluntarily, as they previously had done. Over the years, however, there have been growing concerns that this program has expanded well past the intent of Congress and that patients may not be seeing the benefits they deserve.

Spotlight

In 1992, with the support of the biopharmaceutical industry, Congress created the 340B Drug Discount Program to help uninsured and vulnerable patients gain access to affordable prescription drugs. As part of the law, drug manufacturers provide discounts on outpatient medicines and treatments to select health care entities  often referred to as safety-net providers. The program was necessitated by changes to the Medicaid program that precluded drug makers from continuing to offer steep discounts to safetynet providers voluntarily, as they previously had done. Over the years, however, there have been growing concerns that this program has expanded well past the intent of Congress and that patients may not be seeing the benefits they deserve.

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BUSINESS INSIGHTS

COEUS Holdings Announces Partnership With Insight Consulting Group (ICG) to Address the Healthcare Industry’s Changing Research and Insight Landscape

COEUS Holdings | September 18, 2021

COEUS Holdings, LLC, and its subsidiaries, together a leading boutique life sciences technology and consulting firm, today announced that it has entered a partnership with Insight Consulting Group (ICG). The partnership seeks to bridge the gaps between payers, healthcare providers, and consumers by developing insights and strategies that are reflective of today’s integrated needs. The partnership will produce and apply comprehensive insights to inform strategy that could advance access to more medications and help to address the unmet needs of Physicians and Patients. While ICG’s expertise, proprietary processes, and deliverables will be leveraged by various organizations that are part of COEUS Holdings’ group of subsidiaries, Mirador Global, led Chuck Peipher, Managing Partner, will be most regularly engaged. Mirador delivers consulting expertise in early commercial development for global and domestic drug commercialization and market access efforts. This partnership takes direct aim at the delivery of game-changing insights and market research that will take shape in a variety of touchpoints through the commercial development process. Together, we’ll be able to work more quickly and effectively through this partnership given the common knowledge of the social sciences, brand development processes, and a commitment to our clients who are focused on serving the needs of Physicians and Patients. - Chris Schnaars, Principal at Insight Consulting Group. Ultimately, all stakeholders in the healthcare ecosystem (patients, caregivers, HCPs, influencers, extenders, payers, and provider organizations) must work together to create an optimal care environment. Through shared resources that deliver deeper research and insights, the ICG and COEUS partnership will facilitate a more comprehensive and robust understanding of how healthcare clients can meet the needs and achieve ideal outcomes for all stakeholders. The ICG and COEUS partnership will enable clients to realize the benefits of working with one team, with end-to-end research and payer capabilities. It’s the combination of insights being leveraged simultaneously during the design and development of marketing and payer strategies that will deliver incremental value to the industry. About ICG ICG inspires deeper healthcare understanding by bringing its clients’ most important interactions into research. Understanding human needs and translating them into behavioral insights is at the forefront of the design of our deliverables. ICG brings high proficiency and experience to analysis of insights, raising the bar of confident decision making and commercial impact. ICG is focused on meeting people where they are (not where we want them to be) and understanding what true core human and emotional needs can be addressed to influence behavior and impact outcomes. About Mirador Global LP Founded in 2016, Mirador Global LP is an international consulting practice that specializes in strategic global commercial development for specialty diseases, including rare diseases, oncology/​immuno-oncology, immunology, and CNS disorders. Mirador Global client engagements are developed bringing together Global Marketing, Analytics, Market Access, HEOR, Medical Affairs, R&D, and other functions delivered by a team of pharmaceutical industry experts. The company provides its clients with a bio-pharma line of sight unlike any other unique to Mirador Global. About COEUS Holdings The COEUS Holdings teams are singularly driven to optimize market access and commercialization infrastructure for pharmaceutical products. COEUS is a multi-specialty, commercially aligned consultancy, offering a comprehensive suite of informed solutions for successful engagement with organized customers, providers, and patients. Leveraging years of collective real-world market expertise, we offer unique perspectives into clinical and business opportunities to support your brands’ position in the marketplace. COEUS mission is to ensure patient access beyond the prescription. We focus on becoming your ally in navigating the healthcare universe. COEUS teams advance thought leadership, technology solutions, and communication initiatives to ensure your brands’ lifelong success. Together, we strive to redefine access solutions in the evolving domestic and global managed care markets.

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RESEARCH

Stallergenes Greer and Aptar Pharma Announce Partnership to Develop Novel Connected Device for Allergen Immunotherapy Treatment Delivery

STALLERGENES GREER LTD | October 27, 2021

Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that the company has entered into an exclusive partnership with Aptar Pharma, a global leader in drug delivery systems, services and active material science solutions, for the development of the first of its kind connected device and companion mobile app for patients undergoing Stallergenes Greer’s AIT treatments with sublingual solutions. “This exclusive partnership with Aptar Pharma demonstrates the intensification of Stallergenes Greer’s investments in innovation to provide a large range of precise personalised allergen immunotherapy options adapted to the individual needs and lifestyle of patients. Stallergenes Greer is well advanced on its digital transformation journey and will continue to develop its e-health offering for the benefit of all stakeholders,” stated Dominique Pezziardi, General manager France, Belgium and Luxembourg, Global Head of Pricing and Market Access. Non-adherence to an AIT schedule and premature discontinuation of treatment remain a challenge in AIT management. This innovative, easy-to-use connected device will contribute to improving dose compliance and adherence, thus optimising treatment outcomes. The development work is being undertaken by Aptar Pharma’s Digital Health group, which has capabilities and expertise in device and software development. The product will leverage Aptar Pharma’s Cohero platform, which will be tailored specifically for this use. “We are pleased to combine Aptar Pharma’s Digital Health ecosystem with Stallergenes Greer’s knowledge and leading position in AIT to further improve the treatment journey of patients who suffer from allergiesThe newly developed connected device should be available in France in 2022 and will be progressively rolled-out in Stallergenes Greer’s markets. Sai Shankar, Vice President, Global Digital Healthcare Systems, Aptar Pharma This innovation further illustrates Stallergenes Greer’s commitment to build on precision medicine and personalised healthcare which cater to the needs of both patients and the medical community. ABOUT STALLERGENES GREER LTD Headquartered in London (UK), Stallergenes Greer Ltd is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer Ltd is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). ABOUT APTAR PHARMA Aptar Pharma is part of Aptar Group Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries.

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BUSINESS INSIGHTS

Ablexis and AlivaMab Discovery Services Announce Agreements with Almirall to Accelerate Antibody Drug Discovery and Development

Ablexis, LLC, | January 31, 2022

Ablexis, LLC, a biopharmaceutical company focused on licensing its AlivaMab Mouse technology for antibody drug discovery, and AlivaMab Discovery Services, LLC (“ADS”), a leader in the discovery of superior antibody-based therapeutics, today announced a multi-target licensing agreement between Ablexis and Almirall, S.A. (ALM), a global biopharmaceutical company focused on skin health, and a research partnership between ADS and Almirall. Under the terms of the license with Ablexis, Almirall is granted non-exclusive rights to use the AlivaMab Mouse technology, a state-of-art platform for the generation of human therapeutic antibodies, for the discovery, development and commercialization of antibody drugs. Almirall selected ADS to conduct the drug discovery research, leveraging ADS’ expertise in antibody drug discovery, antibody engineering and platform processes to deliver drug-quality, fully human antibodies on exceptional timelines, including engineering for alternative modalities. “These agreements are in line with Almirall’s vision to develop innovative treatment options for patients suffering from severe skin diseases. AlivaMab Discovery Services’ profound know-how in antibody discovery and engineering together with Almirall's expertise in dermatology will strongly accelerate the development of differentiated treatments to help patients get closer to their goal of leading a healthy life. The agreements highlight the company's commitment to early biologics discovery to provide the best solutions to skin conditions through novel science.” Dr. Thomas Huber, Research Director at Almirall "We are pleased that Almirall has selected the AlivaMab Mouse technology as a key platform for its antibody drug discovery," said Larry Green, Chief Executive Officer at Ablexis, LLC. "Together with the talented and highly experienced team of antibody drug hunters at Ablexis' sister company, AlivaMab Discovery Services, we are increasingly recognized by partners with real experience in antibody drug discovery and development.” “Almirall joins our rapidly expanding list of high-quality partners that leverage the discovery, engineering and developability assessment capabilities of ADS, especially for challenging targets, functional design goals and advanced modalities,” said Justin Mika, Chief Executive Officer at AlivaMab Discovery Services. “Our partners appreciate how our team’s expertise, combined with the proven AlivaMab Mouse platform, significantly improves the probability of success and shortens timelines in discovery and development. We look forward to supporting Almirall’s efforts to help patients with dermatological conditions.” About Ablexis, LLC Ablexis, LLC created and non-exclusively licenses AlivaMab Mouse, a suite of unique, patented next generation transgenic mice, as a platform for human therapeutic antibody discovery. Ablexis has license agreements with dozens of companies, including global pharmaceutical companies, public and private biotechnology companies and other entities. Ablexis continues making AlivaMab Mouse available via non-exclusive licenses. About AlivaMab Discovery Services AlivaMab Discovery Services (ADS) sets its partners’ antibody discovery programs on the fastest and most de-risked path through discovery and development. Trusted by top-tier pharmaceutical and biotechnology companies, ADS delivers drug-quality, fully human antibodies on exceptional timelines. ADS achieves its partners’ design goals, from simple to extraordinarily challenging, through the generation and function-first screening of large, molecularly diverse panels of antibodies. ADS focuses on rapid and efficient delivery of antibodies, characterized for function, kinetics and developability, and engineering for advanced modalities, including multispecifics and CARs. The ADS team’s experience in antibody drug discovery and development comes from many of the world’s top 15 pharmaceutical companies, including AbbVie, AstraZeneca, Bristol Myers Squibb, Novartis, Pfizer and Roche/Genentech, and translates across more than 500 discovery programs and 35 clinical candidates. This experience, combined with the use of trusted, proven technologies, including Ablexis’ AlivaMab® Mouse platforms, ensures the highest probability of success. About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

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