First consortium of local manufacturers to make affordable biosimilars available for low income countries

At the initiative of the World Health Organization, and with the support of Utrecht University, local manufacturers in low income countries will collaborate to bring a biological drug to market for the lowest possible price. The drug, called palivizumab, protects against the common virus RSV. According to the World Health Organization (WHO), this virus is the second most common cause of death in children up to one years of age in low income countries. The four companies, mAbXience, Libbs, Medigen and SPIMACO, have signed a contract for the production of this drug with Utrecht University and the WHO on Wednesday, 9 March.

“This is the first time that commercial parties in low income countries will deal with a global health issue on their own”, explains project founder and Professor of Pharmaceutical Biotechnology at Utrecht University, Huub Schellekens. By sharing the development costs, the companies in the consortium will be able to offer the drug for a much lower price. Utrecht University and University Medical Centre Utrecht will be responsible for the pre-clinical and clinical research and for quality control of the locally produced medicines.

RSV
The cold virus RSV can cause serious respiratory tract infections, especially in premature infants. The disease occasionally requires treatment in a hospital, even in the high income countries. In low income countries, the number of premature births is much higher than in more prosperous countries; around 20% of all births. Unfortunately, prevention is impossible due to the high price of the drug palivizumab, so according to the WHO tens of thousands of children die of the disease every year.

Biosimilars
The active substances in palivizumab are natural proteins of the type that have been used in biological pharmaceuticals available on the market since the early 1990s. As soon as a patent for a biological pharmaceutical expires, other companies release a cheaper biosimilar version of the drug to the market. Unfortunately, local pharmaceutical manufacturers in low income countries often lack the biotechnological knowledge to produce these biosimilars, so they must be imported and remain too expensive for the people who need them.

UCAB
To address this problem, the World Health Organization went looking for a university that had the biotechnological expertise to produce the biosimilars, and that was willing to transfer that knowledge. The WHO chose Utrecht University’s Department of Pharmaceutical Sciences in part due to its leading position in the field. Utrecht University in turn set up the UCAB Foundation to implement the project.

Lunamab
The biosimilar for palivizumab will be developed by UCAB and the pharmaceutical company mAbXience. They will then transfer the necessary technology and knowledge to the other partners in the consortium. UCAB will also arrange for the drug to be approved for release to market in the low income countries. The drug will be named Lunamab, after Prof. Huub Schellekens’ granddaughter Luna. He expects that the drug will be available on the market in the first countries by late 2017.

mAbXience
mAbXience is a subsidiary of the international pharmaceutical firm Chemo. Chemo founder and CEO Hugo Sigman van Chemo has supported Prof. Schellekens’ initiative from the very beginning. The other partners are the Brazilian Libbs, the Taiwanese Medigen and the Saudi Arabian SPIMACO.

Life Sciences
This research is closely related to Utrecht University’s strategic research theme Life Sciences.

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