32 minute read
Clinical R&D
ACHILLES THERAPEUTICS ENROLLS FIRST US PATIENT IN ONGOING PHASE I/IIA STUDY IN ADVANCED NON-SMALL CELL LUNG CANCER
Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, has announced that the first patient in the United States (US) has been enrolled in the Company's ongoing Phase I/IIa CHIRON clinical trial. CHIRON is an open-label, multicenter Phase I/IIa trial evaluating the safety, tolerability, and activity of clonal neoantigen T cell (cNeT) therapy as a single dose in adult patients with advanced metastatic non-small cell lung cancer (NSCLC). cNeT are selectively expanded T cells that target a patient's own clonal neoantigens which are present on all tumor cells but absent from healthy tissue.
This first US patient was enrolled at the Moffitt Cancer Center in Tampa, FL where Dr. Benjamin Creelan is the Principal Investigator. CHIRON is now open at 10 sites in the UK, EU and the US.
"We are delighted to have taken our cutting-edge, cNeT platform into the US with the successful enrollment of the first patient at the Moffitt Cancer Center in our ongoing CHIRON study," said Dr Iraj Ali, CEO of Achilles Therapeutics. "With our cNeT platform we prospectively target patient-specific clonal neoantigens and are able to generate comprehensive characterization including the dose of the active cNeT component for each product. We look forward to providing an update from 10 patients across our CHIRON and THETIS studies in NSCLC and melanoma, respectively, in the fourth quarter of this year where we will present data highlighting a basis for our proposed potency assay."
CHIRON is expected to recruit approximately 40 patients with advanced unresectable or metastatic NSCLC. The primary objective of the trial is to assess the safety and tolerability of cNeT. Clinical efficacy will be evaluated as a secondary measure. Additional data evaluating cNeT persistence, phenotype, and functionality will be reviewed while also exploring potential biomarkers of clinical activity and factors affecting response. This will include analysis of patient samples using a bespoke plasma ctDNA assay. partner Fenton Pharmaceuticals, has won a public tender to provide portable blood and IV fluid warming devices (˚M Warmer System) to The Ministry of Defence (MOD) of the United Kingdom.
The Ministry of Defence is the government department responsible for implementing the defence policy set by Her Majesty's Government. The UK regular forces consist of the Royal Navy, British Army, Royal Air Force, and Strategic Command.
The ˚M Warmer System was chosen by the UK MOD as it has been proven to satisfy all the criteria set for their blood and IV warming needs. The system is not only small, light and robust, but also offers easy and fast setup. Most importantly, it delivers warm blood or IV fluids to patients within a few seconds.
Ulrik Krogh Andersen (CEO) commented, “Fluid resuscitation before arriving at a hospital is shown to significantly reduce mortality among severely injured patients. We are glad that the UK MOD chose our ˚M Warmer System to treat their service people. With their choice, we at °MEQU keep up with our mission to improve the survival and recovery rate of patients regardless of where the injury occurs.”
Graham Hill (MD Fenton Pharmaceuticals) commented, “We are very happy that the UK MOD has chosen the °M Warmer System as the blood and fluid warmer for British troops. We have for quite some time supplied the system to an increasing number of civilian HEMS units, but this confirms that the system is ideal for both civilian and military use.
"There is still a large unmet need in NSCLC where there are very limited options for relapsed patients. We at the Moffitt are pleased to be the first US-based site for the CHIRON study to evaluate this important, precision tumor-infiltrating lymphocyte therapy," said Dr Benjamin C Creelan, Principal Investigator of the CHIRON study and thoracic oncologist at Moffitt Cancer Center. "This is the first US patient to be enrolled to receive a precision T cell therapy specifically targeting clonal neoantigens and we are pleased to be working with the team at Achilles."
HIQA ADVISES ON APPROACHES FOR CONSIDERING THE EXPANSION OF THE NEWBORN BLOODSPOT
The Health Information and Quality Authority (HIQA) has published a report on approaches for considering the expansion of newborn bloodspot screening programmes. This report was provided to the National Screening Advisory Committee (NSAC) to help inform the development of their processes for the assessment of conditions being considered for inclusion in Ireland’s National Newborn Bloodspot Screening Programme (NNBSP).
The NNBSP provides newborn bloodspot screening (the 'heel prick test'), within the first 72 to 120 hours of life. The current NNBSP screens for eight conditions and each year the NNBSP identifies approximately 110 babies in Ireland with one of these conditions. In 2020, the NSAC recommended the addition of a ninth condition to the programme, and, following the approval of this recommendation by the Minister for Health, the HSE has been making arrangements for its inclusion.
HIQA undertook a review of nine countries recognised as having described policy-making processes in place for their newborn bloodspot screening programmes. The review of the academic literature and relevant policy documents examined how and why these countries decide on conditions to screen for. The review also included an examination of the range of conditions currently screened for, as well as the role of emerging technology in NBS programme expansion internationally.
The report notes that, when considering expansion of a screening programme, important ethical, legal and social implications must be taken into account; these include the perspectives of a broad range of stakeholders, such as, the child, their family, scientists, healthcare professionals, and public health professionals. Furthermore, the resources required to expand the programme should be considered at an early stage.
HIQA has recommended that an explicit, structured approach to each aspect of policy-making on this topic should be prepared to ensure consistency and transparency into the future.
Dr Máirín Ryan, HIQA’s Deputy CEO and Director of Health Technology Assessment, said, “The current newborn screening programme is highly successful with consistently high uptake rates, estimated at around 99.9%. In considering further expansion of the programme, it is vital that the existing processes are protected and maintained and that any expansion of the programme is preceded by clearly defined and transparent decision-making to ensure ongoing trust and confidence in the programme.”
Dr Ryan continued: “International screening advisory groups are increasingly recognising the importance of a ‘lifecycle’ approach to making recommendations on newborn bloodspot screening. This includes taking a thorough look at the practicalities of adding a new condition to the programme, and making sure there is a longterm plan for the success of the programme, including its evaluation.”
°MEQU WINS A PUBLIC TENDER TO SUPPLY °M WARMER SYSTEM – PORTABLE BLOOD AND IV WARMING DEVICE TO UK MOD
It has been announced that °MEQU, in co-operation with UK ˚M Warmer System is currently used both in pre-hospital and in-hospital environments, and ˚MEQU is continuously developing its technology to bring warm blood and IV fluids to more patients.”
ROCHE OBTAINS CE MARK FOR THE SARS-COV-2 ANTIGEN SELF-TEST NASAL ALLOWING FOR RAPID SELF-TESTING OF COVID-19 AT HOME
Roche (SIX: RO, ROG; OTCQX: RHHBY) has received CE mark for its SARS-CoV-2 Antigen Self-Test Nasal for at-home testing. The test will be available in countries accepting the CE mark, including Ireland, through pharmacies and other locations, in packs of five tests.
Finbarr Kenny, Director of Ireland, Roche Diagnostics said, "Our new nasal antigen self-test provides results in 15 minutes and has the added advantage of only requiring a sample from the lower part of both nostrils - making it relatively easy and less uncomfortable to perform. The clinical performance of the test was measured by headto-head comparison with our PCR test. With sensitivity between 86 and 91%, the self-test provides a quick and reliable result indicating if a person is currently infectious with Covid-19.
"As we navigate the careful road to recovery from this pandemic, PCR and rapid antigen (lateral flow) testing for COVID-19 can both play a critical role in helping to allow normal activities to resume safely and with confidence."
An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. With the CE Mark, the SARS-CoV-2 Antigen SelfTest Nasal for rapid self-testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways.
By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.
As societies begin to reopen, and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others.
This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARSCoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. These tests will continue to play an important role in fighting this pandemic and remain available for healthcare professional testing.
In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus.
Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
SANOFI LAUNCHES DEDICATED VACCINES MRNA CENTER OF EXCELLENCE
Sanofi will invest approximately ¤400 million annually in a first-ofits kind vaccines mRNA Center of Excellence. The Center will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-toend mRNA vaccine capabilities with dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, MA (US) and Marcy l'Etoile, Lyon (France).
"During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before. However, key areas of innovation such as thermostability and tolerability improvements will be critical to unlock the applications of mRNA in routine vaccination against a broader set of infectious diseases and across all ages. The Sanofi mRNA vaccines Center of Excellence aims to lead the field in this next chapter of vaccine innovation," said JeanFrancois Toussaint, Global Head of Research and Development, Sanofi Pasteur.
The Center of Excellence will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio collaboration established in 2018 and expanded in 2020.
"This massive new investment clearly puts us in the race to develop next-generation vaccines where mRNA technologies can have greatest impact." said Thomas Triomphe, Executive Vice President, Global Head of Sanofi Pasteur. "While mRNA won't be the solution for every infectious disease, its translation into routine prevention could have immense impact for many unmet public health needs. It now becomes a critical new technology in our comprehensive vaccines toolbox, one which could help reinvent health protection in the future."
Sanofi is committed to rapidly establishing an industrycompetitive mRNA platform and is working with our partners and all relevant stakeholders, internally and externally, to achieve this objective.
TAKEDA, RCPE, INSILICOTRIALS AND THE UNIVERSITY OF GRAZ PARTNER UP
Biopharmaceuticals are large and complex drugs that mimic the action of the molecular mechanisms in living organisms. In the past decade, the number of deaths due to cancer and HIV/ AIDS have been significantly reduced and the treatment of several chronic diseases, such as diabetes and cardiovascular diseases, has been enhanced due to the emergence of biopharmaceuticals.
Biopharmaceuticals represent one of the fastest growing segments in current drug pipelines, but their large-scale manufacturing and processing pose specific challenges to the drug formulation scientist, as these large and complex molecules are rather sensitive to variations of environmental conditions and process-induced stress. Filling is the final step of the manufacturing process for liquid protein formulations and the focus of this project.
A 36-month joint project between the manufacturing site in Vienna of Takeda, one of the world's largest pharmaceutical companies, the Research Center Pharmaceutical Engineering (RCPE), the technology company InSilicoTrials, and the University of Graz has been initiated to establish the mechanistic basis of the relationship between process parameters and the effect of the resulting stresses on the characteristics of protein based drugs. Takeda and RCPE are in the process of building an ongoing partnership which has been and is currently being used to increase the scientific knowledge for biopharmaceutical products and processes.
This project will enhance the understanding of the processinduced mechanisms for proteinbased biopharmaceuticals. Participation in collaborative programs of this kind will also be supportive to product and process development of protein-based drugs in the future, resulting in reduced material requirements and drug development timelines.
This collaboration will adopt an innovative approach between Takeda and the partner companies where a lab scale version of one of Takeda's filling line will be designed and assembled. The line will be used to simulate the Takeda filling process on a smaller scale, comparing the effect of various settings of process parameters (filling speed, vial shape, protein concentration etc.). In addition, computational fluid dynamics simulations will be performed to estimate the shear forces, as well as size and dynamics of interfaces the concentrated protein solution is exposed to during the filling process. The generated experimental and simulation data will then be used to train and test algorithms based on state of the art machine learning models, to predict the potential impact of these parameters on the properties of the protein molecule. The final goal is a set of in-silico tools that can be used to guide the design and parameterization of the filling process.
BREAKTHROUGH FOR TRACKING RNA WITH FLUORESCENCE
Researchers at Chalmers University of Technology, Sweden, have succeeded in developing a method to label mRNA molecules, and thereby follow, in real time, their path through cells, using a microscope – without affecting their properties or subsequent activity. The breakthrough could be of great importance in facilitating the development of new RNA-based medicines.
RNA-based therapeutics offer a range of new opportunities to prevent, treat and potentially cure diseases. But currently, the delivery of RNA therapeutics into the cell is inefficient. For new therapeutics to fulfil their potential, the delivery methods need to be optimised. Now, a new method, recently presented in the highly regarded Journal of the American Chemical Society, can provide an important piece of the puzzle of overcoming these challenges and take the development a major step forward.
"Since our method can help solve one of the biggest problems for drug discovery and development, we see that this research can facilitate a paradigm shift from traditional drugs to RNA-based therapeutics," says Marcus Wilhelmsson, Professor at the Department of Chemistry and Chemical Engineering at Chalmers University of Technology, and one of the main authors of the article.
Making mRNA fluorescent without affecting its natural activity
The research behind the method has been done in collaboration with chemists and biologists at Chalmers and the biopharmaceuticals company AstraZeneca, through their joint research centre, FoRmulaEx, as well as a research group at the Pasteur Institute, Paris.
The method involves replacing one of the building blocks of RNA with a fluorescent variant, which, apart from that feature, maintains the natural properties of the original base. The fluorescent units have been developed with the help of a special chemistry, and the researchers have shown that it can then be used to produce messenger RNA (mRNA), without affecting the mRNA's ability to be translated into a protein at natural speed. This represents a breakthrough which has never before been done successfully. The fluorescence furthermore allows the researchers to follow functional mRNA molecules in real time, seeing how they are taken up into cells with the help of a microscope.
A challenge when working with mRNA is that the molecules are very large and charged, but at the same time fragile. They cannot get into cells directly and must therefore be packaged. The method that has proven most successful to date uses very small droplets known as lipid nanoparticles to encapsulate the mRNA. There is still a great need to develop new and more efficient lipid nanoparticles – something which the Chalmers researchers are also working on. To be able to do that, it is necessary to understand how mRNA is taken up into cells. The ability to monitor, in real time, how the lipid nanoparticles and mRNA are distributed through the cell is therefore an important tool.
"The great benefit of this method is that we can now easily see where in the cell the delivered mRNA goes, and in which cells the protein is formed, without losing RNA's natural protein-translating ability," says Elin Esbjörner, Associate Professor at the Department for Biology and Biotechnology and the second lead author of the article.
Crucial information for optimising drug discovery
Researchers in this area can use the method to gain greater knowledge of how the uptake process works, thus accelerating and streamlining the new medicines' discovery process. The new method provides more accurate and detailed knowledge than current methods for studying RNA under a microscope.
"Until now, it has not been possible to measure the natural rate and efficiency with which RNA acts in the cell. This means that you get the wrong answers to the questions you ask when trying to develop a new drug. For example, if you want an answer to what rate a process takes place at, and your method gives you an answer that is a fifth of the correct, drug discovery becomes difficult," explains Marcus Wilhelmsson.
On the way to utilisation – directly into IVA's top 100 list
When the researchers realised what a difference their method could make and how important the new knowledge is for the field, they made their results available as quickly as possible. Recently, the Royal Swedish Academy of Engineering Sciences (IVA) included the project in its annual 100 list and also highlighted it as particularly important for increasing societal resilience to crises. To ensure useful commercialisation of the method, the researchers have submitted a patent application and are planning for a spin-off company, with the support of the business incubator Chalmers Ventures and the Chalmers Innovation Office.
RCSI PARTNERS WITH OLYMPUS TO SUPPORT WOMEN IN SURGERY
RCSI has announced that the third PROGRESS Fellowship for Women in Surgery will be supported by Olympus. The prestigious Fellowship gives female surgeons the opportunity to gain exceptional experience and exposure to their chosen field, supporting their progression to consultant.
RCSI published the 'PROGRESS: Promoting Gender Equality in Surgery' report in 2017, identifying the complex barriers to female progression in surgery. The report called for the provision of a fellowship for female surgeons to inspire exceptional trainees by providing the opportunity to avail of career-defining international fellowship training.
Launched in 2019, the Fellowship enhances the expertise and skill base of Irish female surgeons by supporting their opportunities to gain international exposure in their chosen fields, acquire additional surgical skills, have access to new technologies and contribute to the advancement of surgical science and practice on the island of Ireland.
Ms Ailín Rogers FRCSI received the inaugural Fellowship in robotic colorectal surgery and multivisceral resection for advanced pelvic malignancy at Royal Marsden Hospital in London. In 2021, Ms Helen Mohan FRCSI began her Fellowship in colorectal surgery at Peter MacCallum Cancer centre in Melbourne, Australia. These two Fellowships were supported by Johnson & Johnson Medical Devices.
Professor P. Ronan O'Connell, RCSI President, said: "We are delighted to welcome Olympus as a partner on the 'PROGRESS Women in Surgery Fellowship'. Through this Fellowship, we are committed to taking the necessary steps to remove the barriers that are preventing women from progressing further in surgery, promote a better understanding of the challenges faced by women in surgery and encourage women medical graduates to strive for a career in surgery."
Alison Harvey, Country Manager of Olympus, said: "Olympus are excited to partner with the RCSI on this fellowship and further demonstrate our commitment to improve patient outcomes through supporting the development of Irish female surgeons. By supporting the PROGRESS Women in Surgery Fellowship, Olympus will help promote gender diversity as well as provide opportunities for the recipient of this fellowship to gain essential experience at world leading institutions."
The successful candidate will be awarded a Fellowship up to an amount of ¤45,000, and the RCSI PROGRESS Fellowship Medal which will be presented at the annual RCSI Charter Day Meeting.
The closing date for applications is Monday, 1 November.
EMPAGLIFLOZIN (JARDIANCE®) APPROVED IN IRELAND FOR THE TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION
The European Commission has granted marketing authorisation for Empagliflozin (Jardiance®) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure) in Ireland, Boehringer Ingelheim and Eli Lilly and Company have announced. The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021.
Marketing authorisation is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction (ARR 5.2%) in the combined relative risk versus placebo of cardiovascular death or hospitalisation due to heart failure. The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalisation for heart failure by 30 percent (ARR 8.7%) and significantly slowed kidney function decline.
“Empagliflozin was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Dr Douglas Clark, Head of Medical Affairs for UK and Ireland at Boehringer Ingelheim. “We are delighted to now be able to offer empagliflozin to people with heart failure with reduced ejection fraction, regardless of diabetes status, and to provide an additional treatment option for the thousands of people who live with heart failure and important metabolic conditions. We look forward to collaborating with NCPE to ensure access to this trusted therapy.”
Heart failure is often associated with other diseases of the cardio-renal-metabolic systems such as type 2 diabetes and kidney disease. Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others. Heart failure is a very common and severe complication of a heart attack and occurs when the heart cannot pump sufficient blood to the rest of the body. There are two forms of the condition; heart failure with reduced ejection and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) has approved tralokinumab for the treatment of moderate-tosevere atopic dermatitis in adult patients who are candidates for systemic therapy.
The MHRA and EC approvals make tralokinumab the first and only approved biologic that specifically targets the IL-13 cytokine alone, a key driver of atopic dermatitis signs and symptoms.
Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis. Tralokinumab will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.
Tralokinumab can be used with or without topical corticosteroids (TCS). “Atopic dermatitis can be an intensely itchy, challenging and unpredictable skin condition for some. As clinicians, we always want more options for patients and the approval of tralokinumab means that clinicians across the UK and Ireland now have an important new treatment option for patients with moderate-tosevere atopic dermatitis in adult patients” said Professor Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust.
fraction means the heart cannot contract normally, while preserved ejection fraction means the heart cannot properly fill with blood. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.
The EMPEROR-Reduced trial is part of the EMPOWER clinical programme, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions. The safety profile was similar to the established safety profile of empagliflozin.
HSE REIMBURSES NEW SUBCUTANEOUS FORMULATION OF TYSABRITM (NATALIZUMAB) TO TREAT ADULTS LIVING WITH HIGHLY ACTIVE RELAPSING REMITTING-MULTIPLE SCLEROSIS
Biogen Ireland have announced that the HSE has agreed to reimburse a subcutaneous (SC) injection of TYSABRITM (natalizumab) for adults living with highly active relapsing-remitting multiple sclerosis (MS).
The announcement follows the European Commission’s (EC) decision on the 30th March 2021 meaning that the new route of administration is now approved in Ireland.
Natalizumab SC offers comparable efficacy and safety and builds on the long-term data and established clinical benefits of the natalizumab intravenous (IV) formulation. Natalizumab is the only high-efficacy disease modifying therapy for RRMS that offers two routes of administration providing patients and healthcare professionals (HCPs) with the flexibility to choose the one that best fits their individual needs.
The SC and IV formulations of natalizumab 300 mg, are administered once every four weeks by a HCP in a clinical setting.
The new SC formulation expands the clinical setting beyond infusion centres, potentially bringing care closer to home, e.g., via community healthcare centres, offering patients treatment convenience whilst still providing medical oversight of treatment administration.
The administration by a HCP allows for ongoing disease monitoring, including screening for progressive multifocal leukoencephalopathy (PML), identifying and treating potential hypersensitivity reactions and ensuring adherence to treatment. As well as the shorter SC administration time, compared to the IV formulation, the SC injections also provide the option for HCPs to reduce or remove the 1-hour post-dose observation period, after the first six doses, based on clinical judgement.
“This is an important treatment option for people living with MS, as it provides individuals with more flexibility around how they would like to receive their treatment. It still provides people with the opportunity to access their MS Care team but will minimise the time spent receiving treatment and can potentially be administered in more convenient locations, closer to home” said Ava Battles, CEO, MS Ireland.
The approval of the SC route of administration for natalizumab is based on data from the DELIVER (Phase 1) and REFINE (Phase 2) studies.
The SC formulation of natalizumab 300 mg has shown comparability to the Q4W IV administration of 300mg natalizumab in efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profiles. The safety of natalizumab SC in both the DELIVER and REFINE studies was generally consistent with the well-established benefit-risk profile of natalizumab IV in other clinical studies and the post-marketing setting, with the exception of injection site pain which can occur with SC injections.
“This unprecedented year has put the HSE under significant resource pressures and created new challenges for those living with long-term conditions, like MS, when accessing vital, life impacting treatments,” said Dr Bronagh Hayden, Head of Medical Affairs Biogen Ireland. “As our healthcare and everyday environment evolves, we must continue to provide solutions to address capacity and resource concerns within the health service, whilst addressing patient needs. Reinforced by nearly 15 years of real-world evidence and post marketing experience with natalizumab IV, SC offers a new method of delivery that can help to reduce patient time in a hospital setting and increase convenience in clinical practice.”
LEO PHARMA ANNOUNCES MHRA AND EC APPROVAL OF ADTRALZA (TRALOKINUMAB)
LEO Pharma UK and Ireland, a leader in medical dermatology, has announced that the Medicines
PEMETREXED CLONMEL
Clonmel Healthcare is delighted to announce the launch of Pemetrexed Clonmel 25mg/ml concentrate for solution for infusion.
Pemetrexed Clonmel 25mg/ ml concentrate for solution for infusion is indicated for malignant pleural mesothelioma and non-small cell lung cancer.
Full prescribing information is available on request or alternatively please go to www.clonmel-health.ie. Medicinal product subject to medical prescription.
Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.
PA 126/270/001. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: May 2021. 2021/ADV/PEM/060H.
Astellas by European Commission Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) has announced that the European Commission (EC) has approved an additional indication for the Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, oral once-daily therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-
Ph.D., “Astellas”) has announced that the European Commission sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC). Men diagnosed with mHSPC tend to have a poor prognosis, with a (EC) has approved an additional indication for the oral once-daily median survival of approximately 3-4 years,1 underscoring the need for new treatment options. therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC). Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.
With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC. The EC approval is based on results from the pivotal Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC.
Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).3
The safety analyses of the ARCHES trial appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In ARCHES, Grade 3 or greater adverse events (AEs) (defined as severe/ disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (24.3% vs. 25.6%).3 The EC marketing authorization for enzalutamide in men with mHSPC 1 is applicable to European Union (EU) member countries, and is also valid in Iceland, Norway and Liechtenstein.
This approval will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.
With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castrationresistant prostate cancer (CRPC) and mHSPC. 2 The EC approval is based on results from the pivotal Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC.
3
Data from the ARCHES trial showed enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).
3
The safety analyses of the ARCHES trial appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In ARCHES, Grade 3 or greater adverse events (AEs) (defined as severe/disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (24.3% vs. 25.6%).3 The EC marketing authorization for enzalutamide in men with mHSPC is applicable to European Union (EU) member countries, and is also valid in Iceland, Norway and Liechtenstein.4 This approval will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.
Vimovo® is indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID) -associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.1
Certification No. XTD_2021_0073_IE Date of Preparation: May 2021
Reference: 1. Vimovo Summary of Product Characteristics. Legal classification: POM. Marketing Authorisation number, pack sizes: PA 1019/024/001, 60 packs. Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Further information is available upon request from Grünenthal Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Citywest, Co Dublin. M-VMO-IE-10-20-0002 – October 2020
AXIS Consulting’s recently published Irish Health and Market Access Landscape Report 2021 is a comprehensive overview of the Irish health ecosystem, with critical insights on how the various bodies involved in decision making in Ireland connect and interlink.
The inaugural 42 page report provides a deep understanding of the processes involved in reimbursement and the actual timelines for companies from when they make a submission to the authorities to a final reimbursement decision by the HSE. The report finds that the average time taken between the final NCPE recommendation on a Health Technology Assessment (HTA) to HSE reimbursement approval is on average 13.7 months and notes, that this is considerably longer than the time frame for a reimbursement decision when no HTA has been conducted.
Commenting on the findings, Brenda Dooley, AXIS CEO said “While Ireland has a particularly lengthy timeline to reimbursement decision making, this may be due to HSE funding challenges but is, perhaps, more reflective of the lack of an agreed timeline for pricing discussions”. “At the moment we are awaiting the outcome of the negotiations for a new industry state framework agreement. We are hopeful that an important outcome of the negotiations will be the introduction of a process that expedites the timelines for decision making with regards to the introduction of new medicines in Ireland.”
The Irish Health and Market Access Landscape Report is available to purchase at www.axisconsulting.ie
Brenda Dooley, AXIS CEO
When it comes to your patients’ psoriasis treatment goals
High skin clearance matters to patients: Patients who achieve and maintain high levels of skin clearance (PASI 9099 or PASI 100) have significantly better HRQoL than those with lower levels of skin clearance (PASI 75-89).2
Sustaining high skin clearance or complete skin clearance is associated with incremental and durable benefits in HRQoL and mental health of psoriasis patients.2
What means everything to the patient? The potential for nothing left on their skin.*
* Nothing on the skin: Defined as 75% achievement of PASI90 at Week 16 and ≥50% achievement of PASI 100 at Week 52 in UltIMMa-1 and UltIMMa-2.1
PRESCRIBING INFORMATION (PI)
SKYRIZI®▼ (risankizumab) 75 mg solution for injection in pre-filled syringe. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution. INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg (two 75 mg injections) by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available. Overweight patients: No dose adjustment required. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections (e.g. active tuberculosis). SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. If a serious hypersensivity reaction occurs, administration of Skyrizi should be discontinued immediately and appropriate therapy initiated. Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated. PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from Skyrizi therapy, taking into account the benefit of breast-feeding to the child and the benefit of Skyrizi therapy to the woman. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification
of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; Website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.
LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBERS/PRESENTATIONS: EU/1/19/1361/001: Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes). Further information is available from: AbbVie Ltd., 14 Riverwalk, Citywest Business Campus, Dublin 24. DATE OF REVISION: March 2020. PI/1361/002 HRQoL, Health-Related Quality of Life; PASI, Psoriasis Area Severity Index. REFERENCES: 1. Gordon KB, et al. Lancet 2018; 392: 650-661. 2. Ryan C et al. Poster presented at the 27th European Academy of Dermatology & Venerology (EADV) Congress 2018; September 12–16; Paris, France. Skyrizi® Summary of Product Characteristics, available on www.medicines.ie. Date of preparation: September 2020 | IE-RISN-190074
