As R and D shrinks, UK trials new payment scheme for antibiotics

pharmaphorum | July 09, 2019

With big pharma still abandoning R and D into antibiotics and resistant infections on the rise, the UK has launched a new payment system that it hopes will incentivise the development of new drugs. A new subscription approach will see companies paid upfront for access to new antibiotics based on their value to the NHS, rather than the volume of medicines sold, according to Health Secretary Matt Hancock. The idea is that this will give companies who develop innovative antimicrobials a greater return on their R&D investment than would occur if those drugs are held in reserve for resistant infections, and so only used sparingly. It also removes the incentive for companies to market antibiotics in order to boost sales at a time when the NHS is trying to reduce their use to counter the emergence of antimicrobial resistance (AMR). Hancock said the UK cannot act alone, however, and he urged other countries to follow suit. AMR is becoming a major public health concern around the world, resulting in around 700,000 deaths each year at the moment with fatalities expected to increase as the antibiotic armamentarium loses its potency. Companies are now being asked to propose identify medicines that could be considered for inclusion in the pilot, which will use an adapted NICE health technology assessment (HTA) approach to determine payments teased by Hancock at the World Economic Forum in Davos earlier this year.  “Imagine a world in which a papercut can lead to infection that can’t be controlled. We must stop that from happening,” said Hancock. “Tackling superbugs needs global leadership and peoples’ lives depend on us finding a new way forward.” For decades, pharma companies have been gradually withdrawing from antimicrobial research because they find it hard to get a return on the estimated £1 billion it costs to develop a new drug, turning their attention to more lucrative therapeutic areas such as cancer and diabetes.

Spotlight

The Food and Drug Administration (FDA) or other regulatory body-approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars.

Spotlight

The Food and Drug Administration (FDA) or other regulatory body-approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars.

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BUSINESS INSIGHTS

Accord BioPharma Partners with StoryMD to Deliver Advanced Prostate Cancer Educational Content to Clinicians and Patients

Accord BioPharma | September 21, 2022

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today a partnership with StoryMD. The StoryMD platform is a single, unified, personalized digital health information portfolio that curates the most relevant, visually rich content based on a patient's condition. Accord BioPharma has signed on as StoryMD's very first corporate partner, to support StoryMD's advanced prostate cancer content, allowing Accord BioPharma to provide a comprehensive, user-friendly tool to help patients and their caregivers navigate advanced prostate cancer, just in time for prostate cancer awareness month this September. "At Accord BioPharma, we recognize the need to go beyond biology – and beyond our responsibility of drug development – to help change the clinician and patient experience at all touchpoints in the care continuum where we can," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "StoryMD exemplifies that mission by providing clinicians with clear, easy-to-understand visuals, videos, and health information that help their patients understand their disease journey. Partnering with StoryMD on their advanced prostate cancer content felt like a natural fit given our recent drug launch." In March of this year, Accord BioPharma announced the U.S. launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. CAMCEVI should not be used in patients with hypersensitivity to GnRN, GnRH agonist analogs as anaphylactic reactions to these drugs have been reported in the medical literature. Accord BioPharma is heading all commercial initiatives in the U.S. and Canada. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. Through a vast library of curated, clinically accurate disease-state information, graphics, and videos, StoryMD enables physicians to share an easy-to-understand disease journey with patients at the point of care, which can help increase patient retention of information and engagement, improve physician efficiency, and reduce the amount of misinformation patients may seek out on their own. "Accord BioPharma is making efforts to provide important patient and provider education in pursuit of our aim to offer latest treatment options to patients of advanced prostate cancer and we look forward to our collaboration with StoryMD to provide comprehensive and user-friendly tools for patients and care givers" said Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd, which is the parent company of Accord BioPharma. "Every once in a while, you meet a person and a partner who has a vision. Chrys Kokino has that vision to go beyond drug development and sees the value in advancing technology rather than being afraid of it. And that's exactly what we want – partners who recognize the gap in communication between physicians and patients and who want to work together to close that gap and fill an unmet need." Alexander Tsiaras, CEO and Founder at StoryMD On the importance of prostate cancer awareness, Tsiaras said, "I have a family member who works in the medical field, and when he was diagnosed with prostate cancer, it was amazing how little he knew. Cancer is such a confusing and overwhelming disease – 'Do I wait and watch? Should I be aggressive in treatment?' So, even for the most educated among us, it is a scary moment. Accord BioPharma and StoryMD are working together to go beyond offering patients drug options to impart knowledge and serve as a trusted resource." About Accord BioPharma Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient's experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. About CAMCEVI® CAMCEVI® injection emulsion is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels (less than or equal to 50ng/dL) after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.

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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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PHARMA TECH

Cambrex Completes First Phase of $30 Million Capacity Expansion Project in High Point, North Carolina

Cambrex | September 05, 2022

Cambrex today announced the completion of the first phase of its $30 million investment in its small molecule active pharmaceutical ingredient manufacturing facility in High Point, North Carolina. The newly constructed space adds analytical and chemical development laboratories totaling 30,000 square feet and provides future workspace for 85 analytical and chemical development scientists. These laboratories will support the development of APIs to be manufactured in the facility's current clinical manufacturing area, as well as the future expanded clinical manufacturing and commercial manufacturing suites. "With the growing number of therapies in clinical development and trend toward more targeted therapeutics, including orphan drugs, this expansion is preparing Cambrex to support the growing demand for small-scale API manufacturing. Our expansion goes beyond providing capacity – it provides state-of-the-art technology and laboratory equipment, an energy efficient infrastructure, and an ideal space for our scientific experts to work side-by-side with our clients." Tom Loewald, CEO, Cambrex Phase 2 of the project is ongoing and will approximately double the facility's manufacturing capacity with the addition of clinical and commercial manufacturing suites with reactors up to 2,000 liters. The new commercial area will provide an ideal scale for the manufacturing of orphan drugs and niche therapies, while larger volume products developed at the facility can be manufactured commercially at one of Cambrex's larger scale facilities in Iowa and Sweden. This expansion follows Cambrex's 2021 investment in the Cambrex High Point continuous flow R&D center of excellence, including expanded capabilities for continuous flow process development, manufacturing, and scale up. Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, stability storage, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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