Drug prices come under fire as US pharma lobby nears spending records

europeanpharmaceuticalreview | April 23, 2019

More ambitious changes may be needed to lower pharmaceutical prices as the Trump administration proposes new rules and approves a slew of new generic drugs. Large drug makers and the pharmaceutical industry’s primary trade group neared previous spending records on lobbying in the first three months of 2019 as President Donald Trump and US Congress increase pressure to reduce the cost of medicine.

Spotlight

ISP involves setting different prices for different indications or for distinct patient subpopulations eligible for treatment with a medication. The relative clinical benefit of a drug can vary widely between different indications or between different subpopulations within the same indication. However, despite different clinical benefit across indications, the reimbursement system in the United States, rooted in a history of pricing by dosing unit, assigns a single uniform price to a drug, no matter how it is used. As a result, price and clinical value do not necessarily align well across multiple indications. With multi-indication drugs on the rise, it is important for payers and manufacturers to consider the options through which pricing can better reflect differential benefit by indication.


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Element Materials Technology Announces Completion of its Acquisition by Temasek

Element and Temasek | July 08, 2022

Element Materials Technology a global leader in testing, inspection, and certification services, has completed its acquisition by Temasek, a global investor headquartered in Singapore. Temasek has been a minority shareholder in Element since 2019. Temasek has acquired Element from Bridgepoint, whose successful ownership has been an important part of a more than ten-fold increase in Element’s turnover over the past decade. The acquisition, which was subject to regulatory approvals, was previously announced on 25th January 2022. As a highly differentiated TIC leader with a track record of technical expertise, Element is a trusted partner to customers, supporting them from early R&D, through complex government approvals, and into production, with a focus on laboratory-based testing. Its 7,000+ scientists, engineers, and technologists, based across a global network of more than 200 laboratories in 30 countries, serve technically demanding and highly regulated sectors, ensuring products are safe and sustainable. Element works with customers across a wide spectrum, from developing the next generation of aircraft, spacecraft, and autonomous vehicles, to vaccine component testing in its US pharmaceutical laboratories; and from the certification of smartphones and wearable technologies, to providing 5G carrier approvals and developing connected robots. The Group generates annual revenues of more than $1 billion and has grown at over 20% a year over the last ten years. It is well-positioned to accelerate this growth as it builds deeper leadership positions in critical end-markets including life sciences and connected technologies. Element also benefits from strong global ESG tailwinds - with over 60% of its work directly supporting customers on their sustainability journeys, it will continue to play a critical role in the decarbonization of the global economy. “We are delighted to complete this landmark transaction with Temasek, and to begin work on the next chapter of Element’s story. Their partnership over the last three years has been hugely beneficial to our growth. Today, Element is the partner of choice to companies at the forefront of innovation, from advanced medical science to autonomous cars, and has one of the most talented and highly qualified teams in the TIC space. Jo Wetz, CEO of Element We are excited to build upon that legacy of success and drive Element forward by scaling our business further through strategic investments and acquisitions, with a focus on high growth end-markets such as life sciences and connected technologies. Element will continue to play a crucial role in supporting our customers on their sustainability journeys, and in making tomorrow safer than today.” Allan Leighton, Non-Executive Chairman of Element, said: “Element is a true success story – a talented management team leading an exceptional group of experts across offices and laboratories in more than 30 countries around the world. We’re now entering another exciting chapter of purpose-driven growth, together with our customers and our new owners”. Chris Busby, partner at Bridgepoint, said: “Element has been bold in its ambition, delivered impressive organic growth, and implemented a targeted acquisition strategy. As a result, it has significantly expanded its expertise for over 50,000 customers worldwide and become an undisputed heavyweight in TIC. We are proud of what Element has achieved and wish them continued success in the future.” Element was advised by Bank of America Securities, Goldman Sachs and Rothschild & Co A&O EY BCG DLA, Jamieson and PwC. About Element The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.7,000 scientists, engineers, and technologists, working in our global network of over 200+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable, and achieve market access. In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data. About Temasek Temasek is a global investment company with a net portfolio value of S$381 billion as at 31 March 2021. Headquartered in Singapore, it has 13 offices in nine countries around the world. The Temasek Charter defines Temasek’s three roles as an Investor, Institution, and Steward, which shape its ethos to do well, do right, and do good. As a provider of catalytic capital, it seeks to enable solutions to key global challenges. With sustainability at the core of all Temasek does, it actively seeks sustainable solutions to address present and future challenges, as it captures investible opportunities to bring about a sustainable future for all.

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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.

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BD TO ACQUIRE PARATA SYSTEMS TO ENTER NEW PHARMACY AUTOMATION SOLUTIONS MARKET

BD | June 07, 2022

BD a leading global medical technology company, and Frazier Healthcare Partners, a leading private equity firm focused exclusively on the health care sector, today announced a definitive agreement for BD to acquire Parata Systems, an innovative provider of pharmacy automation solutions, for $1.525 billion. Parata's portfolio of innovative pharmacy automation solutions power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience. Significant macro trends such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacists are driving demand for intelligent workflow solutions. Through the use of automation and advanced software, pharmacists can focus more of their time on higher value clinical work and patient interactions to help improve medication adherence, medication safety and patient outcomes. The transaction will be complementary to BD's solutions in medication management with a new set of technologies across the care continuum, including acute care health systems, retail pharmacies, long-term care and home settings. Parata provides BD access to a new $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. Together with BD, the company expects Parata's solutions to outpace market growth through BD's commercial footprint, global scale and innovation capabilities. "Parata expands BD's solutions to a new area of the high-growth pharmacy automation space and is a prime example of BD executing our disciplined M&A strategy. Parata has a highly attractive financial profile and compelling value proposition that meets all of our rigorous investment criteria on growth, profitability and returns. With the addition of Parata, BD further advances our 2025 growth strategy around smart, connected care and enabling new care settings. We look forward to welcoming the talented Parata team to BD." Tom Polen, chairman, chief executive officer and president of BD Rob Kill, chief executive officer of Parata added, "BD and Parata share a common purpose with closely aligned cultures. We are very proud of the company the team has built at Parata over the past 21 years and feel BD is a great home for our company, innovative solutions and technology, and Parata's team members. The combination with BD will further advance our purpose of powering pharmacies to help people lead healthier lives." About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. About Parata Systems Parata provides pharmacy technology solutions to reduce costs, enhance patient safety and improve the patient experience by offering a comprehensive pharmacy automation portfolio with medication adherence packaging, high-speed robotic dispensing technologies and pharmacy workflow solutions. About Frazier Healthcare Partners Founded in 1991, Frazier Healthcare Partners is a leading private equity firm focused exclusively on the healthcare sector. With over $7.1 billion in total capital raised, Frazier has invested in more than 200 companies with transaction types ranging from buyouts of profitable healthcare services companies to venture capital and company creation. Frazier has a philosophy of partnering with strong management teams while leveraging its internal operating resources and network to build exceptional companies. Frazier has offices in Seattle, WA, and Menlo Park, CA, and invests broadly across the U.S., Canada, and Europe.

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Global Pharmaceutical Market Drives Innovative Digitalization to Accelerate Drug Discovery

Frost & Sullivan | June 17, 2022

Frost & Sullivan's recent analysis, Global Pharmaceuticals Outlook, finds that the accelerated drug development timelines are driving digitalization and innovation across the pharmaceutical value chain. Data, the decentralization of clinical trials, supply-chain resilience, digital therapeutics, and manufacturing automation are the key areas driving digitalization. The industry also ensures that healthcare will remain precise, preventive, and outcome-based in promoting social and financial inclusion. The global pharmaceuticals market, including small molecules and biologics, is expected to register 3.8% growth, garnering $1.48 trillion by the end of 2022 from $1.43 trillion in 2021 under the aspirational scenario. "The partnerships and horizontal integration of technology companies with life science companies have laid the foundation for rapid and cost-effective drug discovery and development. Further, all major genomics technology companies are channeling their resources to digitalize genomic data for better selection of patients for clinical trials and to reduce the turnaround time for clinical studies." Surbhi Gupta, Healthcare & Life Sciences Senior Industry Analyst Gupta added: "Owing to the growing use of machine learning and artificial intelligence in personalized medicine, the pharmaceuticals industry will move from a symptom-driven treatment approach to a genetics-based approach. Additionally, precision medicine can offer in-depth information about cellular and molecular alterations, accelerating the development of targeted therapies." Digitalization and innovation in the pharmaceuticals industry will unlock new growth opportunities, including: Digital therapeutics companies must excel in areas where many pharmaceutical companies are lacking, including data analytics, interoperability, user-centric design, and flexible business models. Innovative formulation and delivery technologies that improve RNA stability at ambient temperatures will facilitate the rapid global adoption of RNA-based treatments at reduced costs. Contract development and manufacturing companies should partner with global companies to meet the required experience in clinical drug manufacturing and expand market reach in Asia-Pacific. Global Pharmaceuticals Outlook, 2022 is the latest addition to Frost & Sullivan's Healthcare & Life Sciences research and analyses available through the Frost & Sullivan Leadership Council, which helps organizations identify a continuous flow of growth opportunities to succeed in an unpredictable future. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion

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Spotlight

ISP involves setting different prices for different indications or for distinct patient subpopulations eligible for treatment with a medication. The relative clinical benefit of a drug can vary widely between different indications or between different subpopulations within the same indication. However, despite different clinical benefit across indications, the reimbursement system in the United States, rooted in a history of pricing by dosing unit, assigns a single uniform price to a drug, no matter how it is used. As a result, price and clinical value do not necessarily align well across multiple indications. With multi-indication drugs on the rise, it is important for payers and manufacturers to consider the options through which pricing can better reflect differential benefit by indication.

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