Veriton Pharma Ltd has been announced as the new company name for Special Products Ltd.
This name change has occurred both to incorporate the company’s past heritage with its future ambitions to make trusted medicines available for everyday living.
The Chief Commercial Officer commented:
With the launch of Epistatus® 10mg in 1mL Oromucosal Solution Midazolam (as maleate), on the 8th of September 2017, and our extensive range of existing unlicensed medicines, we would like to assure our customers and partners that the excellent service and quality they have come to expect from us as a company will continue and all contacts at the company will remain the same.”
With its legacy of technical expertise, which began in a world-renowned children’s hospital over 20 years ago, Veriton Pharma sources and supplies licensed medicines for CNS and over 75 high-quality, UK batch manufactured unlicensed medicines in the fields of epilepsy, neurology and rare paediatric conditions that licensed products cannot meet.
Headquartered in Weybridge, UK, Veriton Pharma, is a privately owned, speciality pharmaceutical company which also has regional offices in the Middle East and Australia.
Source: The Christchurch Group Published online: 8/1/18
A neurological rehabilitation centre in Lincolnshire has been rated ‘Outstanding’ by the Care Quality Commission (CQC), placing it in the top 1% of healthcare services in the UK.
The Laurels, which opened in 2014 and is run by Christchurch Group, provides specialist community-based transitional rehabilitation in north-east Lincoln. It supports adults with neurological conditions resulting from injury, illness or disease. The service offers accommodation for 12 residents and is a Headway Approved Provider.
Inspectors praised the service for its calm and caring atmosphere, its strong, values-led leadership and the creative and individualised approach to support displayed by the registered manager and staff, which provided clear therapeutic benefits for residents. The CQC also highlighted how residents were actively involved in the preparation and on-going review of their personal care plan and supported to make decisions about how they wanted to be supported.
Richard McKenzie, Christchurch Group Chief Operations Officer, added:
I am delighted that the Laurels has been awarded ‘Outstanding’ status. We are proud to deliver life-changing, evidence-based outcomes for adults with neurological conditions. To have a service recognised as being in the top 1% of regulated healthcare services in the UK is an incredible achievement.
Veriton Pharma Ltd (formerly Special Products Ltd) has announced that Epistatus® 10mg Oromucosal Solution, Midazolam, is now available to prescribe. The NHS price for a single 10mg in 1mL pre-filled syringe is £45.76.
Epistatus® is licensed for use in the treatment of prolonged, acute convulsive seizures in children and adolescents aged 10 to less than 18 years, who have been diagnosed with epilepsy1. Buccal midazolam is recommended by NICE2 for the management of prolonged acute convulsive seizures, and is preferred by most patients and carers compared to the administration of rectal diazepam3,4.
Epistatus is presented “ready-to-use” in a novel, pre-filled, single-dose syringe, to provide carers with the confidence that they are administering the correct dose1,5. The pre-filled syringe is contained within a specially-designed, secure and tamper-evident protective packaging.
Dr Rohit Shankar FRCPsych, Consultant in Adult Developmental Neuropsychiatry – CFT and Hon. Associate Clinical Professor – Exeter Medical School commented:
The importance of having an alternate licensed preparation for use in the treatment of prolonged, acute convulsive seizures, especially in a different mode of delivery is an asset to both clinicians and patients.
In response to market research and insights, Veriton Pharma has invested heavily in the development of this new bespoke syringe, which is designed to allow simple administration of the dose into the buccal cavity5.
For further information on Epistatus 10mg oromucosal midazolam pre-filled syringes, please visit http://www.epistatus.co.uk
References:
Epistatus 10mg oromucosal solution. Summary of Product Characteristics.
National Institute for Health and Care Excellence (2012). The epilepsies: the diagnosis and management of epilepsies in adults and children in primary care. NICE clinical guideline CG 137.
Nakken K and Lossius M. Buccal midazolam or rectal diazepam for treatment of residential adult patients with serial seizures or status epilepticus. Acta Neurol Scand: (2011); 124:99-103.
Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children. European Journal of Paediatric Neurology (2010); doi10.1016/j.ejpn.2010.05.009.
Data on le – Excerpts from Epistatus Patent Application.
Source: News provided by BrainTrainUK Published online: 8/1/18
Advanced QEEG Brain Mapping (AQBM) is now available for the first time in Europe. Using Sterman-Kaiser Imaging Labs software, AQBM is a significant advance on existing QEEGs. AQBM captures more data and provides unprecedented levels of information, analysis and interpretation.
Analysis includes:
Peak Frequency
Sensory integration
Visual perception & memory integration
Motor, body, emotive ability
Social & executive perception
Cortico-limbic integration
Verified neuromarkers for pyschological pathologies
The analysis of corticolimbic integration makes AQBM unique. The tool assesses the balance of instinct and reason driving interpretation and behaviour. Neuromarkers identify correlations between EEG patterns and traits by Brodmann Area.” AQBM enable increased understanding of brain functions for therapy and inform EEG Biofeedback protocols.
Managing Director Stuart Black
Available in BrainTrainUK’s clinic locations in London, Surrey, Bucks, Herts and Yorkshire. For more information call 0207 118 0887 or email enquiries@braintrainuk.com
Advocacy Centre North’s advocacy service for people with neurological conditions in Newcastle and Gatesheadhas completed its second year. Thanks to funding from the Big Lottery Fund we have been delivering this pioneering service, which is the first and only specialist advocacy service in the country for people with neurological conditions, including stroke, acquired brain injury, Parkinson’s, Multiple Sclerosis, muscular dystrophy, Motor Neurone Disease and autism.
The service is provided using both paid and volunteer advocates who receive specialist training delivered in partnership with Northern Neurological Alliance. Their specialist knowledge of this client group and their needs significantly enhances the service. The trained advocates have offered Independent Advocacy on a wide range of issues ensuring people with neurological conditions have access to the services that they need and that they communicate their wishes in often challenging circumstances.
During the first year we set up the service in a way that ensures it meets the needs of people with neurological conditions and the service:
Provided 2358 hours of direct advocacy support to 69 people
Recruited and trained 12 new volunteer Advocates 100% of clients who returned questionnaires said their advocate was “excellent”. During the second year we are proud to say that the service:
Provided 3835 hours of direct advocacy support to 111 people
Recruited, trained and supervised 44 volunteer advocates
Supported people with 20 different neurological conditions, some with multiple conditions and some with no diagnosis as yet.
Our Neurological Advocacy Service is being externally evaluated by Barefoot Research and Evaluation. An interim report covering the first 18 months of the service has been published. It includes case studies, statistics and recommendations.
The report says:
After 18 months, the project has become well established with two highly specialised neurological advocates and a developing team of trained volunteers. The service is working with a diverse caseload with a number of complex cases referred in from a range of sources, including self and family. They are developing as a centre of expertise in Newcastle and Gateshead for neurological advocacy services. The client need is showing some early differences to other advocacy services, such as higher number of cases per referral and an increased complexity to those cases. These differences will be monitored as the project and evaluation progresses.
Advocacy Centre North is part of Newcastle Council for Voluntary Service. Information about Advocacy Centre North and how to refer to this and our other services is available at: http://www.advocacycentrenorth.org.uk
Conference details: 16-19 November, San Francisco, USA Report by:IBTA Conflict of Interest Statement: None declared Published online: 6/12/17
This year’s Annual Meeting of the Society for Neuro-Oncology and Education Day (SNO 2017) represented one of the most significant events in the brain tumour research calendar.
The event saw the coming together of nearly 2,500 brain tumour researchers, clinicians, patient organisation representatives, and other stakeholders from across the globe. A wide range of topics was addressed: there were 88 oral platform presentations; 128 rapid reports; 90 e-poster presentations and 770 traditional poster presentations. Fifty countries were represented. SNO 2017 presentation abstracts can be viewed online here
The Society for Neuro-Oncology has produced two informative ‘Daily Highlights’ videos that summarise a selection of important findings presented on the 17th and 18th November at SNO 2017.
A selection of short videos with interviews, highlighting some of the key findings covered at the Meeting (courtesy of Practice Update, free registration required) can be found via the links below:
Survival benefit of Optune is correlated with the amount of daily use, trial analysis shows
A retrospective analysis of a phase III trial (EF-14) of Optune – a wearable Tumor Treating Fields device – in newly diagnosed glioblastoma has demonstrated a link between length of use and clinical effect. Findings presented on 17th November at SNO 2017, showed that patients who used the device more than 90% of the time had the greatest survival (24.9 months), while those who wore the device for the prescribed 70 – 80% of the day had an average (median) survival of 21.7 months. However, even those who had a lower compliance rate of 50% had “benefit in terms of progression-free survival”, the results showed. Read more. A separate analysis of the EF-14 trial data, also presented at SNO 2017, showed that newly diagnosed glioblastoma patients receiving Optune therapy who continued using the device after first recurrence also appeared to have a survival benefit, compared to those who did not use the device. Read more (conference abstract).
Ovarian cancer drug breaches blood-brain-barrier around glioblastoma and may be an effective brain tumour treatment, study shows
Results from the OPARATIC phase I trial of olaparib, a chemotherapy agent used in ovarian cancer, alongside temozolomide in recurrent glioblastoma were presented at SNO 2017 on 16th November. According to the study, analysis of brain tumour tissue revealed that olaparib penetrated throughout the tumour mass where the blood-brain-barrier is disturbed, but did not enter unaffected regions of the brain where the blood-brain-barrier was intact. Researchers also identified an intermittent dosing regimen to reduce side-effects, and these findings have paved the way for two additional clinical trials – PARADIGM and PARADIGM-2 – that will test olaparib in combination with radiotherapy and temozolomide in newly diagnosed glioblastoma. Results from the trial were also presented earlier in the month at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool, UK.
Small clinical trial suggests adding cannabinoids to temozolomide may lengthen survival in recurrent glioblastoma
Presented at SNO 2017, results of a small randomised double-blind placebo-controlled trial provide evidence that a preparation of cannabinoids (CBD:THC) co-administered with temozolomide may improve survival in recurrent glioblastoma. Twenty one patients receiving temozolomide were randomly assigned CBD:THC or placebo, and the survival at one year was 83% with CBD:THC, compared with 44% for placebo. “Further investigation of CBD:THC in patients with glioblastoma is warranted”, conclude the study’s authors. View poster presentation (pdf file).
Depatux-m (ABT-414) combined with temozolomide may improve survival in recurrent glioblastoma, phase II trial results show
First results of the randomised phase II clinical trial of depatux–m (ABT-414) in recurrent glioblastoma (with EGFR amplified status) has shown that it may improve survival when combined with temozolomide, although the trial’s primary endpoint was not met. The research also stated that: “The main toxicity observed in depatux-m treated patients was ocular (grade 3: 27.9%, grade 4: 1%).” Depatux-m is an antibody combined with a drug that selectively targets tumour cells that overexpress the EGFR molecule, a feature present in 40-50% of glioblastomas. Read more (SNO 2017 abstract).
Medicenna presents updates on phase I and II clinical trials of MDNA55 in recurrent glioblastoma
The pharmaceutical company Medicenna has given an update on drug distribution and safety data from the first 15 recurrent glioblastoma patients treated to date in a phase IIb clinical trial of MDNA55, a drug delivered into the brain via a catheter that targets the overexpressed interleukin-4 receptor on glioblastoma cells. Presented at SNO 2017 on 16th November, the results show greater coverage of tumour with MDNA55 than in previous trials, with some patients’ tumours achieving near 100% coverage. Read more. This phase IIb trial commenced in December 2016 and is presently recruiting recurrent or progressive glioblastoma patients. More information (Clinicaltrials.gov website).
Studies suggest that ‘liquid biopsy’ may aid childhood medulloblastoma and brain metastasis treatment planning
It may be possible to use a ‘liquid biopsy’ to monitor the progress of childhood diffuse intrinsic pontine glioma (DIPG), according to findings from a study presented at SNO 2017. Researchers showed that tumour DNA could be extracted from patient blood and cerebrospinal fluid (the fluid around the spinal cord and brain) and analysed. Levels of circulating tumour DNA showed correlation with radiotherapy effect and has the potential to track treatment response, forgoing the need for tumour biopsy, the authors suggest. “We detected H3K27M, a major driver mutation in DIPG, in about 80 percent of cerebrospinal fluid and plasma samples”, the lead author said. Read more.
A separate study also examining ‘liquid biopsies’, presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress in Singapore on November 17, has shown that it may be possible to detect mutations in the EGFR gene in brain metastases in lung cancer patients, potentially aiding treatment decisions (tyrosine kinase inhibitors are beneficial in this subset of patients). Read more.
4/1/2018: More highlights from SNO 2017
A round-up of noteworthy research presented at the meeting has also been compiled by the Musella Foundation, and can be viewed online here. A series of videos with highlights from the conference has been made available by the Society for Neuro-Oncology and can be watched via their website here.
News from the European Headache Foundation Congress Enrico Greppi Award for study supported and funded by Allergan The award is supported by the Italian Society for the Study of Headaches (SISC) and endorsed by the EHF.
2017 Enrico Greppi Award Winner: Fluctuations in Episodic and Chronic Migraine Status Over the Course of One Year: Implications for Diagnosis, Treatment and Clinical Trial Design1
Relatively little is known about the stability of a diagnosis of episodic migraine (EM; <15 headache days) or chronic migraine (CM; ≥15 headache days) over time. The researchers in this study examined natural fluctuations in self-reported headache frequency as well as the stability and variation in migraine type (EM and CM).1
The researchers analysed longitudinal data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study in US adults with CM and EM to better characterise within-person change in the headache days. At baseline 5,464 respondents had EM, 525 respondents had CM. Using negative binomial repeated measures regression models (NBRMR) they found that the rate of headache days increased 26% increase per observation wave for CM compared to EM (rate ratio 1.26; 95% CI, 1.2–1.33).1
Key findings include:
There are substantial variation in headache day frequency in people with EM and CM followed at three-month intervals1
Nearly 75% of people with CM experienced less than 15 headache days during assessment at some time point during the 12-month period1
Transitions from EM to CM are more common than previously observed1
This natural variation should be considered when diagnosing, treating and studying CM1
Headache day diagnosis is often assumed to be relatively stable for an individual, however this research suggests that headache frequency can be variable. This could impact a patient’s diagnosis, potentially moving them over time between the CM and EM diagnostic categories. For example, when a patient transitions from 16 headache days per month to 14 days per month, their diagnosis may change, but the underlying pathophysiology of their disorder does not change.1
Importantly, these findings should prompt clinicians to assess how they interpret the effects of preventative treatment in practice. Clinicians often rely on a short term improvement in headache days to determine treatment effectiveness, but these results show that a variation in headache days may not be related to treatment, and that a longer term assessment may be required.1
Richard Lipton, MD, Vice Chair of Neurology, Albert Einstein College of Medicine, and an author on the paper comments: “There is a traditional bright line of 15 headache days per month that separates people with episodic migraine from those with chronic migraine, but people with migraine experience striking fluctuations in the frequency of their headaches. Therefore headache days alone, in any particular time period, may not be sufficient to distinguish between episodic and chronic migraine. More data is needed to fully understand the underlying biological differences.”
References
Serrano D et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design, The Journal of Headache and Pain, 2017, 18:101
Data from the Phase III STRIVE study reported erenumab cut in half the number of days with migraine symptoms for 50 percent of patients with episodic migraine1
Across the UK, an estimated 8.5 million people live with migraine and research suggests the condition is likely to impact the lives of almost 200,000 people every day2
Erenumab is the first and only fully human monoclonal antibody specifically designed to block the CGRP receptor, which plays a critical role in migraine activation.
On 30th November, Novartis announced that the New England Journal of Medicine (NEJM) has published positive results from the pivotal Phase III STRIVE study, which showed 50 percent of people using erenumab 140 mg for six months instead of placebo saw the amount of migraines experienced over a month reduced by at least half.1
Migraine is more prevalent than diabetes, epilepsy and asthma combined3 and almost 200,000 people across the UK are impacted by migraine every day.2 There is an urgent need for new treatment options and erenumab is the first and only fully human monoclonal antibody of its kind designed to specifically prevent migraine. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.
“STRIVE is the first fully reported Phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine,” said Peter Goadsby, M.D., Ph.D., FAHS, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College Hospital, London. “The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.”
These data show erenumab can significantly reduce the number of monthly migraine days experienced by patients, with a 3.7-day and 3.2-day reduction with erenumab 140 mg and 70 mg, respectively, from a baseline of 8.3-days (1.8-day reduction with placebo). Additionally, 50 percent of patients treated with erenumab 140 mg had the number of days with migraine symptoms cut by at least half (this figure was 43.3% following treatment with erenumab 70 mg, and 26.6% with placebo). Results from the Migraine Physical Function Impact Diary (MPFID) show patients treated with erenumab also reported improved physical health and ability to participate in daily activities over the six month trial period. Furthermore, erenumab has been shown to be effective and tolerable over the long term with a safety profile comparable to placebo.1
Migraine is too often trivialised as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives. The effects can last for hours – even days in many cases. An option that can prevent migraine and that is well tolerated is therefore sorely needed and we hope that this marks the start of real change in how this condition is treated and perceived.” Simon Evans, Chief Executive, Migraine Action
“Migraine is a highly debilitating neurological condition that affects millions of people across the UK; more must be done urgently in order to help reduce the huge personal, societal and economic burden associated with migraine”, said Dimitrios Georgiopoulos Chief Scientific Officer, Novartis UK. “Erenumab is the most significant breakthrough in this field in 20 years and it is now imperative we continue to work with all parties to make this well-tolerated and effective treatment option for migraine available to those who can benefit from it.”
Erenumab is the first investigational therapy targeting the CGRP pathway to have received FDA and EMA regulatory filing acceptance to date. The STRIVE study is one of the pivotal trials included in the US and EU regulatory applications under review for erenumab.
About STRIVE
STRIVE (NCT02456740) is a global Phase III, multicentre, randomised 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in episodic migraine (4 to 14 migraine days a month) prevention. In the study, 955 patients were randomised to receive once-monthly subcutaneous placebo, or erenumab (70mg or 140mg) in a 1:1:1 ratio. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline. The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study (months 4, 5 and 6).4
Secondary study endpoints assessed in the same treatment phase included the proportion of patients with a reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days. The impact of migraine on physical function and the impact on everyday activities were each assessed as secondary endpoints by the novel Migraine Physical Function Impact Diary (MPFID).
Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID).5 Treatment with erenumab was well tolerated, with a safety profile comparable to placebo.1
About erenumab (AMG 334)
Erenumab (AMG 334) is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which plays an important role in migraine activation. Erenumab has been studied in several large global, randomised, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have participated in our clinical trial programme across the four placebo-controlled Phase II and Phase III clinical studies and their open-label extensions.
4 ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention (STRIVE). Available at: https://clinicaltrials.gov/ct2/show/NCT02456740. Accessed October 2017.
NICE also recommends use of Merck’s multiple sclerosis therapy cladribine tablets (Mavenclad®) for highly active disease in adults
Today (9th November 2017) sees the approval by NHS England of a commercial agreement that allows NHS patients in England immediate access to the innovative new multiple sclerosis (MS) treatment, cladribine tablets (Mavenclad®).1 NHS England and Merck, the manufacturer of cladribine tablets, have partnered on the commercial access agreement, representing an example of a “win-win-win” for the NHS, patients and industry at a time of intense financial pressure on the NHS.
Alleviating pressure on NHS services is critical, as the MS population has outgrown the services available and MS as a condition is costing the UK economy between £3.3bn-£4.2bn each year.2
Elisabeth Prchla, Merck UK General Manager, said:
We are delighted with the NHS England decision on this commercial agreement, which will see patients in England access the treatment immediately. This is a first of its kind in multiple sclerosis, which can also be a benchmark for the future, bringing together the NHS, government and industry to achieve faster access for patients, in line with the UK’s Life Sciences Industrial Strategy.
She continued, “This milestone underscores our commitment to unmet needs in the MS community – we have been working closely with NHS England to find a solution that not only provides access to our medicine as early as possible but will also save the NHS money at a time of immense financial pressures.”
This commercial agreement follows the recent positive recommendation from the National Institute for Health and Care Excellence (NICE).3 Last week, NICE issued a Final Appraisal Determination (FAD) that recommends cladribine tablets as an option for treating highly active MS in adults. Use of cladribine tablets is recommended only if a person has rapidly evolving severe relapsing–remitting multiple sclerosis, that is, at least two relapses in the previous year and at least one T1 gadolinium-enhancing lesion at baseline MRI or relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as one relapse in the previous year and MRI evidence of disease activity.3
This is the first MS disease-modifying therapy that has gone straight to a positive final recommendation in the NICE appraisal process, involving just one committee meeting. In the FAD, NICE concluded that cladribine tablets are less costly than other treatments and require less frequent dosing and monitoring requirements. The recommendation in the FAD forms the basis of NICE’s final guidance (Technology Appraisal Guidance, TAG), anticipated in early 2018, and once this is published the NHS must provide funding within 90 days.3
Merck is committed to improving the lives of patients with MS through the delivery of innovative medicines and patient support programmes. We are delighted that cladribine tablets are now available for certain patients with highly active relapsing-remitting MS and proud to have worked together with NICE and NHS England to deliver this treatment as early as possible,
Marco Lyons, Head of Medical Neurology and Immunology at Merck
Cladribine tablets are taken for a maximum of 10 days in the first year and a maximum of 10 days in the second year, with no additional treatment needed in years three and four. Patients can take cladribine tablets at home from the first dose as treatment does not require hospital administration.4 Monitoring is limited to the first two years only, meaning that cladribine tablets have the lowest administration and monitoring burden of all available high efficacy disease modifying therapies.4-8
Cladribine tablets received marketing authorisation from the European Commission in August 2017 based on an extensive 12-year clinical trial programme.9-13 The comprehensive dataset has informed the treatment regimen and monitoring requirements. The most clinically relevant adverse reactions are lymphopenia and herpes zoster (shingles). Pre-treatment assessments are required before initiating treatment and lymphocyte counts must be assessed before, and during, treatment in the first two years. Cladribine tablets should not be taken by certain people, including immunocompromised patients and pregnant women.4
References
1 Commercial agreement for cladribine tablets (MAVENCLAD®). NHS England November 2017
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