Scotland backs Aimovig for migraine after NICE says no

pharmaphorum | April 09, 2019

People suffering from severe migraines in Scotland will be able to get treatment with Amgen and Novartis’ Aimovig if they fail other therapies, according to the country’s cost-effectiveness agency for medicines. The Scottish Medicines Consortium (SMC) has given its backing to routine use of the calcitonin gene-related peptide (CGRP) inhibitor throughout NHS Scotland for people who have at least four migraine days per month, and for whom at least three prior preventive treatments have failed. The verdict comes a few weeks after Aimovig (erenumab) was turned down for the same indication in draft guidance from the National Institute for Health and Care Excellence (NICE) in England, once again threatening a disparity in access to a new medicine in different areas of the UK.
The NICE appraisal of Aimovig is still ongoing, however, with final guidance expected to be published in the second quarter. “The high frequency and severity of migraine symptoms can be extremely debilitating and may have a substantial impact on day-to-day and work related activities,” said the SMC in its advice on the drug.

Spotlight

Poorly coordinated care transitions from hospitals to other care settings contribute to avoidable healthcare costs, according to a new infographic by Cureatr. The infographic examines six best practices for improving care transitions.


Other News
BUSINESS INSIGHTS

Integral Molecular and Optimeos Life Sciences Enter Partnership to Develop mRNA and DNA-Based Gene Therapies Using Molecular Targeting

Integral Molecular | June 09, 2022

Integral Molecular and Optimeos Life Sciences announce a partnership to develop next-generation mRNA and DNA therapeutics that will use antibody-based molecular targeting to direct vaccines and gene therapies to relevant tissues in a patient's body. This partnership combines Integral Molecular's experience in antibody discovery and mRNA immunization with Optimeos' technology for nanoparticle-based drug delivery systems. DNA and mRNA therapeutics harness a patient's own molecular machinery to encode proteins. Integral Molecular and Optimeos plan to encapsulate these therapeutic molecules within nanoparticle spheres that are decorated with antibodies on the outer surface. The antibodies can then target the particles to specific tissues. Currently, gene therapies and mRNA vaccines are delivered into the body via infusion or injection, but only a fraction of the molecules arrive at their intended site. The proposed molecular targeting strategy has the potential to transform the delivery of vaccines and therapeutics by dramatically reducing dosages, decreasing toxicity, and enabling scalable administration. Integral Molecular will apply its industry-leading antibody discovery expertise against complex cell-surface proteins to provide targeting moieties for the therapies. Its specialized MPS Antibody Discovery platform is tailored to work with challenging membrane protein targets and routinely uses mRNA-based immunization strategies. "Precision targeting of an isolated cell type with gene therapy holds great promise for genetic diseases and may provide brand-new directions in cancer immunotherapy including in vivo CAR-T cell therapeutics," said Joseph Rucker, Co-founder and VP of R&D at Integral Molecular. Optimeos' technology allows the robust and scalable incorporation of mRNA and DNA therapeutics and other biologics into customizable nanoparticles. "We are excited to work with Integral Molecular towards the next generation of gene-therapy that no longer relies on viral-based delivery systems," said Robert Prud'homme, Co-founder and Chief Technical Officer of Optimeos. Integral Molecular and Optimeos will be attending the BIO International Convention in San Diego later this month. About Integral Molecular Integral Molecular is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses. About Optimeos Life Sciences Optimeos Life Sciences has developed a novel, highly differentiated, non-viral, nanoparticle technology, for delivery of new therapeutic drugs to address important unmet medical needs. The technology is a patented and scalable polymeric drug delivery system, which was developed and refined in Professor Prud'homme's lab at Princeton University over 20 years. Optimeos' technology enables encapsulation of mRNA, DNA, peptides, proteins or small molecules, as well as their targeted delivery to cells and tissues beyond the liver.

Read More

BUSINESS INSIGHTS

Vetsource Expands Its Solution Set to Include Data and Insights, Client Engagement

Vetsource | February 28, 2022

Vetsource®, a pet health company that provides innovative pharmacy, technology and business services designed to help customers provide products and services to those who care for pets, has added data and insights, and client engagement offerings to its portfolio of customer solutions. Previously focused primarily on the home delivery of prescription and nonprescription items on behalf of veterinary practices, Vetsource has expanded its services in order to build a world-class infrastructure to help its veterinary practice, industry and retail customers deliver a competitive and personalized experience for their clients. The portfolio expansion is the result of Vetsource's investment in two companies – VetSuccess and Vet2Pet – as part of a long-term strategy to continue to meet the needs of its customers, and ultimately pet owners. "As the veterinary market has evolved, we've recognized the need to expand our solution set to help our customers engage with their clients in meaningful ways and leverage data to improve compliance rates and revenue. These services are a natural complement to our prescription management solution," Kurt Green, Vetsource CEO As the industry's leading data experts, VetSuccess provides performance reports, dashboards, and data services to veterinary practices, as well as robust analytics and quantitative veterinary insights to industry partners. These intuitive and interactive solutions allow customers to gain a deeper understanding of business performance, uncover actionable insights and make confident decisions that improve day-to-day operations. "With our strong alignment on company culture and core values, VetSuccess is a natural fit to join forces with Vetsource," said Katie McClean, Managing Director of VetSuccess. "We're proud to apply our expertise to help Vetsource deliver a data-driven platform that simplifies workflows and fosters growth for veterinary practices, ultimately providing the solutions partners need to break barriers and build bridges that strengthen the human-animal bond." Vet2Pet offers veterinary medicine's only customizable, all-in-one client connection system and app. Features like appointment management, pharmacy refills, 2-way chatting and texting, reminders, and rewards programs make it easy for practices and pet owners to interact, increase practice revenue, and save staff an average of three hours of phone time each day. "Joining Vetsource will help us achieve the dream we've had for Vet2Pet since its inception. Veterinarians will now have access to sophisticated software that elevates the client experience, improves team efficiency, and helps practices retain their pharmacies. This is a win for everyone," said Dr. Stacee Santi, Managing Director of Vet2Pet. In addition to product development, Vetsource has made significant investments in its workforce, leadership, and pharmacy operations, including the addition of a new pharmacy on the East Coast in 2021. Over the last three years, Vetsource has focused on building the teams that will drive products forward by more than doubling its workforce, including a deep investment in engineering talent. Vetsource recently hired Chief Product Officer, Ami Murthy, who brings extensive experience in product management and consumer ecommerce from leadership roles at companies such as eBay and Amazon. "Our dedication to providing a powerful platform is demonstrated not only in the investments we have made in enhancing our products, but also in the expertise of our teams," added Green. "After more than a decade as a pioneer in this market we want to continue to lead the way and we're just getting started." About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and their caretakers. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement. Founded in 2008 to help veterinary practices compete in the online marketplace with a home delivery solution, Vetsource expanded with the acquisitions of VetSuccess and Vet2Pet. Comprising over 500 employees, Vetsource is headquartered in Portland, Ore., with additional offices in Colorado, Oklahoma, Pennsylvania and Toronto, as well as multiple pharmacy locations.

Read More

BUSINESS INSIGHTS

FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis

Regeneron Pharmaceuticals, Inc. | May 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo Nodularis People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Read More

BUSINESS INSIGHTS

FSD Pharma Announces Launch of New Corporate Website

FSD Pharma Inc. | January 24, 2022

FSD Pharma Inc. a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today the launch of its newly designed website. The new site conveys the Company’s emerging position within the biopharmaceutical industry and its ongoing commitment to bring novel treatment solutions for brain and inflammatory disorders to millions of patients in need. “We have strategically assembled a team of scientists to help develop our powerful pipeline of next-generation therapeutics. With some of the greatest minds in neurology and inflammation working together to advance our promising therapeutic compounds, and supported by a strong balance sheet, we believe that we are very well positioned to continue the advancement of our three leading drug candidates: Lucid-MS, Lucid-PSYCH and FSD-PEA. The new look and user-friendly experience of FSD Pharma’s website reflects that, while also serving to educate clinicians, researchers, patients, and investors about our unique approach to delivering 'Total Brain Health'.” Anthony Durkacz, Interim CEO of FSD Pharma About FSD Pharma FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc. a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, ultra-micronized palmitoyl ethylamine or FSD-PEA Lucid Psycheceuticals Inc. a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-PSYCH and Lucid-MS. Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

Read More

Spotlight

Poorly coordinated care transitions from hospitals to other care settings contribute to avoidable healthcare costs, according to a new infographic by Cureatr. The infographic examines six best practices for improving care transitions.

Resources