Pharmaceutical Market Europe • July/August 2022 • 8-9
NEWS
Bristol Myers Squibb (BMS) announced that analysis from two phase 3 trials of Zeposia (ozanimod) showed early use of the treatment demonstrated cognitive benefits in people with relapsing multiple sclerosis (MS).
The greatest effect of the treatments was seen in people with high thalamic volume (TV), supporting an association between preserved brain volume (BV) and improved long-term cognitive outcomes.
MS is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body, affecting approximately 2.5 million people worldwide.
Relapsing forms are characterised by unpredictable attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS.
Zeposia was approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS in March 2020, while the European Commission authorised the drug for the treatment of adult patients with relapsing remitting MS with active disease in May 2020.
Zeposia is designed to bind to S1P receptors 1 and 5, reducing the capacity of lymphocytes to migrate from lymphoid tissue and decreasing the number of circulating lymphocytes in the blood.
Novartis has announced positive results from a phase 3 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) for patients with advanced oesophageal cancer, regardless of PD-L1 status.
Results from the RATIONALE 306 study showed tislelizumab plus chemotherapy reduced the risk of death by 34%, with the treatment demonstrating a median OS of 17.2 months, compared to 10.6 months in patients receiving chemotherapy plus a placebo.
Tislelizumab is a humanised immunoglobulin G4 monoclonal antibody designed to minimise binding to Fc gamma receptors on macrophages, which may result in anti-PD-1 resistance.
The treatment is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed oesophageal cancer, and the FDA was due to deliver its verdict by 12 July.
The EMA is also reviewing the drug for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.
BeiGene, tislelizumab’s original developer, has already secured approval for the PD-1 inhibitor in China for the treatment of non-small cell lung cancer (NSCLC), classical Hodgkin’s lymphoma, liver cancer hepatocellular carcinoma (HCC) and PD-L1-high urothelial carcinoma.
Through a collaboration and licence agreement with BeiGene, Novartis has the rights to develop, manufacture and commercialise tislelizumab in North America, Europe and Japan.
Pfizer has announced its commitment to further reduce its Greenhouse Gas (GHG) emissions, aiming to achieve a voluntary net-zero target by 2040, ten years earlier than the expectations of the Net-Zero Standard.
The Net-Zero Standard urges long-term action to reduce company emissions by 95% and value chain emissions by 90%.
To meet this commitment, Pfizer will need to move away from the use of fossil fuels at an accelerated rate, which will include the use of a fleet of hybrid and electric vehicles, and will encourage suppliers to take similar action.
The company is working with suppliers to encourage a commitment to climate change that includes establishing a GHG baseline by the end of 2022 and setting a reduction target by the end of 2025.
The company has also signed a pledge by the US Department of Health and Human Services (HHS) that calls on stakeholders in the US healthcare system to reduce GHG emissions and ‘build a more climate resilient healthcare infrastructure’.
Between 2000 and 2020, the company reduced company emissions by over 60%.
In 2020, Pfizer announced a plan to become carbon-neutral by 2030 and to reduce Scope 1 & 2 GHG emissions by 46% from a 2019 baseline.
A new report calls for ‘critical action’ from healthcare decision-makers to ensure the COVID-19-driven surge in virtual health and care drives health access and equity.
The report, The Future of Health and Care – driving access and equity through inclusive policies, from the Broadband Commission for Sustainable Development Working Group on Virtual Health and Care, co-chaired by the World Health Organization (WHO) and the Novartis Foundation (Novartis), details how the past two years have changed access to health and care in 23 countries.
The insights from the report form the foundation for a comprehensive roadmap providing practical actions to help countries ensure inclusive access to virtual services for entire populations.
It found that the use of virtual health solutions and care solutions surged during the pandemic. In the US, the percentage of telehealth claims (compared to all health claims) was 25 times higher in January 2022 compared to 2019.
However, many countries are yet to develop coherent frameworks to ensure virtual health services work effectively alongside in-person care.
The report also acknowledges that some population groups may have less access to mobile phones and internet or lower levels of digital literacy, meaning countries have to ensure equitable policymaking to further integrate virtual services into their health systems.
The EFPIA-EURORDIS joint statement on patient access to medicines for rare diseases across Europe has been published.
The statement is based on an 18-month structured dialogue between the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EURORDIS, a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
A conceptual framework for Equity-Based Tiered Pricing (EBTP) to better align medicines’ prices with countries’ ability to pay is proposed in the statement.
A number of proposals are also included, supported by both EFPIA and EURORDIS, that aim to improve pricing and reimbursement processes and Health Technology Assessment (HTA), at both EU and member state level.
The final proposal recognises the significant number of rare conditions where no treatment option exists and focuses on the launch of a Moonshot to stimulate translational research for the development of medicines that will address some of the remaining unmet medical needs of rare disease patients.
The report acknowledges that the recommendations it contains cannot ‘entirely alleviate the access challenge that rare disease patients face’ but the organisations believe that these proposals ‘collectively represent an important step forward and a foundation for future collaboration’.
Gilead Sciences has announced it has signed the Kigali Declaration for neglected tropical diseases (NTDs), joining the global community seeking to end NTDs by 2030.
The declaration aims to increase government support and secure commitments to achieve the SDG3 target on NTDs and to deliver the targets set out in the World Health Organization’s (WHO) Neglected Tropical Disease Roadmap which includes global targets to prevent, control and in some cases eliminate 20 diseases and disease groups by 2030.
Gilead has committed to supporting and investing in global initiatives that will address health equity. It will also spearhead and contribute to a broad stakeholder dialogue driving pharmaceutical sector engagement and investment in tackling environmental issues causing NTDs, such as climate change and lack of access to clean water.
These efforts are in addition to the company’s commitment to ending visceral leishmaniasis (VL) and it will continue its product donation to the VL elimination programme led by WHO between 2023 and 2027.
Although progress has been made in the fight against NTDs, with WHO reporting that an estimated 10.6 million malaria deaths and 1.7 billion malaria cases were averted from 2000 to 2020, the global toll of malaria and NTDs remains high.