Key European committee backs GWs Epidyolex, Bayers Vitrakvi and more

Fiercepharma | July 26, 2019

In a busy meeting this week, experts with the European Medicines Agencys Committee for Medicinal Products for Human Use endorsed four new drugs, a Mylan generic, and numerous new indications for already-marketed meds. All the recommendations will go to the European Commission for final approval. Aside from those decisions, the committee also endorsed a new generic from Mylan to Novartis’ Exjade, which treats chronic iron overload. The drug generated $578 million outside the U.S. last year. And the experts signed off on label expansions from several meds including Merck’s Keytruda, Alexion’s Soliris, Johnson & Johnson’s Stelara and Roche’s Tecentriq. Some drugs CHMP previously rejected will get new reviews. UCB's Evenity for osteoporosis will get another look after a previous rejection, and experts will review label expansions for Novartis’ Revolade and PTC Therapeutics’ Translarna after rejecting earlier bids.

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BUSINESS INSIGHTS

Illuccix® Available on High Activity Gallium Generator Technology to Meet High Demand

Telix Pharmaceuticals Limited | November 23, 2022

Telix Pharmaceuticals Limited announces Illuccix® with up to 50mCi for radiolabeling is available for use on 100mCi gallium generators, an important development in radioisotope production. High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area and gain greater production efficiency. "As the only commercially available kit that can take advantage of high activity generators for up to 50mCi radiolabeling, Illuccix gives hospitals, pharmacies, and physicians added confidence that their dose scheduling needs – and the needs of their patients – can be met today and in the future as the potential of 68Ga PSMA-11 is realized in the diagnostic market. We are pleased to continue our collaborative relationships with IRE ELiT and EZAG to continue to make 68Ga PSMA-11 accessible and convenient to use for customers across the United States." Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix Jay Simon, Managing Director of Eckert and Ziegler North America said, "The high activity GalliaPharm® generator may allow for broader availability and expanded service areas. It is about delivering doses when and where they are needed, whether you're a remotely located clinic, a busy metropolitan hospital or a pharmacy. We are pleased to be working with Telix to harness this innovation to maximize the efficiency for our customers and ultimately, their patients." Jean Bonnet, Head of Sales, Strategy and Marketing at IRE Group said, "While current generator technology is sufficient to meet today's demands, the rollout of the higher activity 100mCi generators are future-proofing the ability to meet demand in a market which is growing exponentially. The use of high activity generators has the potential to increase daily elutions and increase the activity in each elution. When radiolabeled up to 50mCi with Illuccix, the result could potentially provide more flexibilitty in meeting the growing demand for 68Ga radiopharmaceuticals while giving customers the benefit of greater dose scheduling flexibility and efficient production." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

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PHARMACY MARKET

ICON selected by BARDA to conduct anthrax vaccine clinical trial

ICON plc | October 07, 2022

ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial. BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance. ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations. “We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.” Edward Wright, President, ICON Government and Public Health Solutions This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023. BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development. Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores. Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics. About ICON plc ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022. About ICON Government & Public Health Solutions ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts. About BARDA’s Medical Countermeasures Clinical Studies Network (CSN) The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.

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PHARMACY MARKET, PHARMA TECH

GoodRx Expands Pharmacy Services Platform With $150M vitaCare Acquisition

GoodRx | October 21, 2022

To circumvent overpriced prescription drugs and grow its robust pharmacy services platform, GoodRx finalized its vitaCare acquisition. Based on a transaction that started in the first quarter of 2022, GoodRx agreed to secure vitaCare for $150 million in cash. Based on vitaCare’s financial performance through 2023, an additional $7 million consideration is also possible. A report cited by Globe Newswire showed that the global pharmacy market size has a forecasted value of $1,627.74 billion by 2030. Pharmaceutical platforms, with accessible clinical programs and digital adoptions, have a positive impact on today’s healthcare system, with vitaCare as one of the promising brands. vitaCare, a healthcare service platform, offers cost-effective solutions to patients. More precisely, the platform helps individuals navigate insurance coverage and its optimized benefits to attain lower-priced medications. Rising investments in pharmacy services have sparked interest in vitaCare, including that of GoodRx. The acquisition of vitaCare is in line with GoodRx’s mission, though. Co-CEO Doug Hirsch states that the company seeks to relieve the financial burden that comes with securing medication. Pharma manufacturers have constantly observed barriers to proper patient care, especially for affordable medicine and complicated reimbursement processes. With vitaCare at the helm, new tools are utilized to ensure more patients are linked to relevant savings programs and transparent pricing information. Hirsch hopes that the acquisition will facilitate a smoother brand prescription process overall. Profit-wise, GoodRx predicts the deal will contribute under 1% of its total revenue in 2022, though there is no substantial long-term discern. This acquisition is the latest in GoodRx’s commitment to delivering consumer-focused healthcare services. The company has a history of connecting individuals to accessible, research-based health information. One of the most notable ones is its partnership with Wheel in 2021, which generated better outcomes for patient care. Telemedicine software provider Wheel offers flexible clinical services to a broad patient base. Wheel’s platform equips clinics with the capability of synchronous and asynchronous consults. It utilizes network virtualization to create a seamless experience for healthcare providers and patients. Our post ‘Network Virtualization: The Future of Businesses and Networks’ previously discussed how virtualization empowers a software’s scalability — and this certainly manifests in Wheel’s platform. Providers can choose from a range of services that enhance patient care. One of the services is ePrescription medications, which remotely administers prescriptions. Following the integration of GoodRx’s technology into Wheel’s platform, health providers and patients alike can meet reduced costs of care. As it stands, GoodRx’s coupon price API operates with over 200 billion pricing data points daily. Consumers use these to identify lower-priced medications. With the integration, Wheel-mobilized clinics can offer their patients a GoodRx coupon. GoodRx can also adapt its services to remote healthcare activities through the partnership. After all, GoodRx is essentially a marketplace. Ultimately, GoodRx champions solutions that provide consumers with affordable healthcare access and medication. With vitaCare among its ranks today, the company can focus on promoting better patient adherence to treatment plans.

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PHARMA TECH

ArisGlobal Accelerates Growth Announces Executive Evolution

ArisGlobal | September 08, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today announces an expansion to its C-suite. James Jarrett is the company's new Chief Financial Officer, Kathleen Turland joins as the first Chief Legal Officer, and Aman Wasan has stepped into the new role of Chief Commercial Officer. The three appointments are happening during a time of significant momentum for ArisGlobal, which has experienced annual recurring revenue growth of 34% in the first half of 2022 YoY. James Jarrett, Chief Financial Officer Jarrett brings over a decade of executive leadership experience driving revenue and cash flow growth. He has partnered with management teams and boards of directors of high-growth, highly leveraged companies undergoing rapid change. Prior to joining ArisGlobal, he served as the CFO for Emergence Health Holdings, Carewell Urgent Care, and ProCure Proton Therapy Center. Kathleen Turland, Chief Legal Officer Turland is a global strategic leader with more than 20 years of legal experience. She brings her broad range of legal and business skills to ArisGlobal, having worked with companies experiencing significant growth and expansion over the years, including General Electric, and FUSE Group. She started her legal career in New York, clerking for a Federal Court Judge, and working at two revered New York law firms. Aman Wasan, Chief Commercial Officer Wasan is an expert in general management and commercial leadership with a deep understanding and knowledge of drug safety and clinical research. Since joining ArisGlobal in 2018, Wasan has excelled in six different positions, most recently as Senior Vice President of Global Commercials, where he managed global enterprise business. Before joining the ArisGlobal team, Wasan worked for Bioclinica as the company's Global Head of Safety and Regulatory Services. "As we continue scaling our business and building new functions to better serve our customer base, expanding our C-suite will help us execute our mission and further drive our success in the life sciences industry. James, Kathleen, and Aman carry a wealth of industry knowledge instrumental in empowering ArisGlobal to further expand its customer pipeline, continue to develop innovative technology, and maintain a role as a trusted leader in the market." CEO Mike Gordon Turland's addition to the company also represents consistent and focused efforts by ArisGlobal to continually put women in positions of leadership. Turland joins ArisGlobal veterans Ritu Shrivastava, Vice President Corporate Development, and Heidi Hattendorf, Vice President of Marketing, on the executive team. Currently, ArisGlobal also has women in core leadership positions across business, product, quality, people, and technology functions. About ArisGlobal ArisGlobal is led by passionate individuals who support life sciences leaders in developing and monitoring breakthrough medicines and therapies. With more than 35 years of expertise in the life sciences industry, ArisGlobal develops technology products within the platform LifeSphere to power pharmaceutical and biotech research and development. Building on our commitment to corporate social responsibility and sustainability initiatives, we give back to the communities where we live and work – in the U.S, Europe, India, Japan, and China.

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Food For Thought? Pills. Three times a day, all your nutrients, all your favorite flavors. Feel like having lobster for breakfast? Done. Trying to like mushrooms, but can’t stand the texture? Problem solved. Meal replacement pills are the future. At least, that’s what people have been saying for the past century. So what if we got them now? How would they affect our diet? Would we be healthier? Could they solve world hunger? Will we see them in our lifetime?

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