mAbxience has been selected by the WHO and UCAB (The Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health ) to lead the project aimed at developing Palivizumab biosimilar (Synagis®), alongside the University of Utrecht in the Netherlands. This monoclonal antibody is used to prevent Respiratory Syncytial Virus (VRS), a disease that currently stands as the second global cause of infant mortality in babies and premature born babies under the age of one year according to data from the WHO.
The biosimilar development is being promoted by the World Health Organisation and is aimed at guaranteeing that every country can gain access to this treatment. Palivizumab has proved to be highly effective in the prevention of RSV, especially in high-risk children. However, the high cost of this medicine means it cannot be widely administered in many developing countries, which are precisely those where the virus is most prevalent and presents the highest mortality rates. According to data from The Lancet, between 66,000 and 199,999 children died from complications stemming from RSV in 2005. 99% of those deaths were recorded in developing countries.
Biosimilars are medicines of an equivalent nature in terms of quality, effectiveness and safety to their benchmark biologics that are developed once the patent on the original product has expired, thereby enabling the price to be lowered significantly.
mAbxience and the University of Utrecht (through its Centre of Excellence for Accessible Biotherapies (UCAB) will undertake the work to develop this biosimilar medicine. They will subsequently transfer the technology, information and resulting know-how to local producers in those countries where the drug will be commercialised so they can assume responsibility for its manufacture. However, in those cases in which its not possible, mAbxience will supply the medicine.
The biosimilar development will be jointly financed by those stakeholders involved in the process. A collaborative model has been adopted that will enable a cost reduction for every party. Furthermore, the development is being promoted by the WHO through technical support and advice.
In this regard, Martin Friede (Team Leader, WHO Technology Transfer Initiative) is delighted that mAbxience has been chosen as the lead partner for the project by the University of Utrecht, “We look forward to working with mAbxience to ensure that a high-quality and affordable version of Palivizumab will be developed, approved and made available”. The WHO has entered into a memorandum of understanding with the University of Utrecht, which will be responsible for managing the technical aspects aimed at ensuring that biosimilars are made to improve access to essential medicines in developing countries.
The founder of mAbxience, Hugo Sigman, said that “We are proud that the WHO took us into consideration in order to take part in this project, highlighting the fact that our commitment and experience in the development and production of biosimilar monoclonal antibodies, which meet the highest quality standards has achieved recognition from the leading international bodies”.
RSV is a disease, which even if it only causes cold-like symptoms in adults, it has a serious impact on children, especially amongst premature babies and amongst those who might be suffering from other diseases. The virus causes lung and respiratory tract infections that can eventually also affect the heart and immune system, leading to other types of pathology.