The enterprise, supported by the World Health Organization (WHO), covers the development of palivizumab, a drug indicated to prevent severe respiratory infection in newborns.
Libbs, a national pharmaceutical industry, signed in March 2016 its participation in the international partnership for development and production of the monoclonal antibody – palivizumab, indicated to prevent infection in newborns, mainly premature babies, by the respiratory syncytial virus (RSV).
According to WHO data, every year are recorded about 60 million cases of the disease with over 160 thousand deaths of babies worldwide, caused by RSV. Because it is an expensive drug, the main objective of the partnership is to offer the product at an affordable price, suitable to the economy of each country, in order to expand access and save the lives of a greater number of babies.
The project will be coordinated by the Utrecht University, in The Netherlands, with support from WHO, and developed by our associate mAbxience, by Libbs, Medigen, Taiwan pharmaceutical industry and by Spimaco, Saudi Arabia pharmaceutical industry. We expect palivizumab t be available within about 5 years.
The director of unit B2B at Libbs, Marco Dacal, says that this proposal was presented in late 2013, when the project of other biological drugs of Libbs was in advanced stage of its schedule. “Our associate at Biotec, mAbxience, told us about their development of a monoclonal antibody to a relevant pathology, the infection caused by RSV, one of the deadliest diseases for newborns worldwide. What caught our attention was the fact that this drug, able to save lives, was generally underused, mainly in countries as Brazil”, says Dacal.
The first meeting of the project was held in 2014, at Utrecht University. “At first there was about 10 pharmaceutical companies interested in the partnership. However, only those with greater relevance and conditions to produce and distribute the palivizumab locally were selected, such as Libbs, due to our entry into the segment of monoclonal antibodies”, explains.
It is worth mentioning that mAbxience is the key company in this partnership, due to its know-how to develop an enterprise of this magnitude. “We need to emphasize the importance of this initiative and its complexity, since in the biological drugs sector, the product is the process itself, and each company will have their own technology transfer. On the other hand, it is essential to point out that the development of biosimilar palivizumab is following all the necessary requirements to guarantee a safe and effective final product”, says Dacal.
Dacal also explains that, at first, this is not a Product Development Partnership (PDP), although, along the process, it may become a PDP, mainly because of its relevance in reducing mortality of newborns and the impact on the health budget. “For illustrative purposes and according to international guidelines, vaccination with palivizumab is recommended for premature babies below 32 weeks. In Brazil this procedure is given for babies below 28 weeks. However, between 28th and 32nd weeks, there is huge potential to save these babies”, explains Dacal.
More about palivizumab
Palivizumab is a monoclonal antibody, suitable to prevent infection by respiratory syncytial virus, one of the main causes of death of newborns. The drug is administered as vaccine, in five doses, one per month, throughout the period of greatest risk of infection.