October 2022 • PharmaTimes Magazine • 9
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Stada launches prostate cancer
treatment across 21 European countries
Stada is broadening its offering to patients, pharmacists and physicians in Europe by introducing abiraterone acetate 500mg film-coated tablets in 21 European countries.
Used for treating metastatic prostate cancer, abiraterone adds to Stada’s comprehensive oncology offering that spans oral and injectable medicines, including biological agents such as bevacizumab and epoetin zeta.
Upon the expiry of market protection for the abiraterone reference brand, Zytiga, abiraterone will launch in several European countries including France, Germany, Italy, Spain and Nordic markets. Stada’s generic version is authorised for the same indications as the reference product.
Used in combination with prednisone or prednisolone, abiraterone stops the body producing the male hormone testosterone. Abiraterone does this by blocking an enzyme called CYP17, found in the testes and elsewhere in the body. Due to the cancer needing a supply of testosterone to survive and grow, by reducing the production of testosterone, abiraterone may slow the growth of prostate cancer.
According to the European Commission and the European Cancer Information System, in 2020 more than 335,000 new cases of prostate cancer were recorded in the EU, with almost 70,000 deaths.
With around one in 11 men developing prostate cancer during their lifetime, the Commission estimates that, in EU-27 countries in 2020, prostate cancer accounted for 23.2% of all new cancer cases (excluding non-melanoma skin cancers) diagnosed in men and for 9.9% of all deaths due to cancer in men.
UCB reveals new Bimzelx ‘complete skin clearance’ data
UCB has announced new three-year results from the BE BRIGHT open-label extension study evaluating the long-term safety, tolerability and efficacy of Bimzelx – also known bimekizumab – in adults with moderate to severe plaque psoriasis who completed one of three pivotal phase 3 studies.
This data, together with a three-year safety analysis of pooled data from phase 2 and 3 studies, was presented at the European Academy of Dermatology and Venereology (EADV) Congress in Milan. A total of eleven abstracts highlighting data related to bimekizumab in psoriasis are being presented at the congress.
Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Data presented from the BE BRIGHT study showed that over eight out of ten patients who achieved complete skin clearance (PASI 100) – following 16 weeks of bimekizumab treatment – maintained PASI 100 response and health-related quality of life outcomes for three years with continuous maintenance dosing.
Pooled data from up to three years of treatment in phase 2 and 3 clinical trials showed that bimekizumab was generally well-tolerated over this period with no safety signals identified.
HOT & NOT
PrecisionLife – a company that generates insights into disease biology to create novel precision medicines for chronic diseases – has unveiled the results of a study that provides the first detailed genetic insights into the pathophysiological mechanisms underpinning myalgic encephalomyelitis or chronic fatigue syndrome.
It is the first time that replicable genetic findings have been reported in over 30 years of study into the disease, offering new approaches for better diagnosis and treatment of patients.
The European Union has granted stem cell specialist Neuroplast an orphan medicinal product designation for the applicability of its stem cell technology platform to frontotemporal dementia, following a positive opinion from The European Medicines Agency.
With an existing orphan disease designation for traumatic spinal cord injury, Neuro-Cells is now approved for a fast-track development pathway with market exclusivity for both a trauma-induced and chronic degenerative central nervous system disorder.
PhoreMost – the UK-based biopharmaceutical company dedicated to ‘drugging the undruggable’ – has announced a multi-project target discovery collaboration with Roche. Under the terms of the agreement, PhoreMost will receive an upfront payment and is also eligible for preclinical success-based milestones.
The company is set to deploy its in-house expertise and next-generation phenotypic screening platform, Siteseeker, across several disease-relevant pathways nominated by Roche, while novel targets identified will be further validated by Roche.
The European Commission has granted marketing authorisation to Polpharma Biologics, Formycon and Bioeq jointly developed treatment Ranivisio – also known as ranibizumab – a biosimilar of Lucentis. The original therapy is already a treatment for several serious retinal diseases across the EU.
EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein.
Liz Truss will urgently need to grip the crisis facing the NHS ahead of a gruelling winter by providing extra support that hospitals, ambulances, mental health and GP services need to deal with intensifying pressure.
NHS leaders say the Prime Minister will inherit an NHS in the most challenging state it has been in for decades, with front-line services facing lengthening waiting times and other pressures, which are undermining the NHS being the best it can be for our patients.
NHS leaders from across England, Wales and Northern Ireland are warning of rising numbers of people falling ill and worsening health outcomes across the country, unless the government takes urgent action to limit further energy price increases.
They fear a widening of health inequalities for people living in communities with the highest levels of deprivation if individuals and families are driven further into poverty because of excessive energy costs.
Liz Truss will be expected to make a series of critical economic decisions relating to the 'cost of living crisis' in the next few weeks.