Friday, June 28, 2013

International Medica Foundation outlicenses China rights to its neonatal rotavirus vaccine to Shanghai BravoBio

The International Medica Foundation has outlicensed to Shanghai BravoBio Co., Ltd. of China,  rights to Rotashield -  the first rotavirus vaccine that has been clinically tested for use in newborns. Shanghai BravoBio will be responsible for developing the vaccine in China.  
Rotashield has several attributes, which makes it the ideal rotavirus vaccine, of which the important ones being
1) Neonatal dosing will ensure protection from disease at an earlier age. This is specifically importatn from a developing countries perspective as rotavirus in developing countries strikes infants at a younger age than in industrialized countries. Up to 15 percent of rotavirus illness occurs before three months of age in developing countries

2)Second, neonatal dosing would fit with the World Health Organization (WHO) schedule that includes a BCG vaccine at birth and the three remaining immunization visits at six, 10, and 14 weeks, therefore, neonatal dosing is an ideal time to give a vaccine in developing countries since that is when most infants will come in contact with a health care provider

3)Third, the neonatal schedule of two doses versus the original three-dose schedule would significantly reduce the cost of providing vaccine to a large number of infants. Finally, neonatal dosing minimizes the risk of intussusception associated with dosing at an older age

This will be the first time that a rotavirus vaccine will be developed for the Chinese market where the first dose of the rotavirus vaccine will be orally administered to newborns. 

International Medica has been developing a rotavirus vaccine for global use to overcome the shortcomings of the currently marketed rotavirus vaccines, which do not protect very young infants, may be associated with an increased risk of vaccine associated intussusception (a blockage of the intestine which requires hospitalization), are costly and require expensive refrigerated storage. 

International Medica's oral rotavirus vaccine addresses all of these problems. Based on the RRV-TV vaccine originally developed at the National Institutions of Health, International Medica has successfully completed a large safety and efficacy Phase 2 clinical trial in Africa in 998 young infants that received both doses of the vaccine before they were 2 months old. "We are very pleased that our vaccine is providing strong, early protection to infants, usually before the first dose of other rotavirus vaccines is even administered. As recently reported in the Journal of Infectious Diseases, two early doses of our RRV-TV vaccine is comparable in efficacy to three doses of other rotavirus vaccines given later to older infants," says Dr. Leonard Ruiz, President of International Medica. 

The International Medica Foundation is a nonprofit foundation, headquartered in Rochester, Minnesota, that focuses on developing a safe, effective and affordable rotavirus vaccine that is clinically tested and then can be provided to families throughout the world. International Medica is seeking private sector commercialization partners for other regions of the globe.

About Shanghai BravoBio Co Ltd

Shanghai BravoBio Co., Ltd. is a private biotech firm headquartered in Shanghai, and has multiple sites in China. Its main business is to develop, manufacture and market preventative, therapeutic, and diagnostic biologics in China, focusing on human vaccines.

About Rotavirus Vaccine

Rotavirus is a vaccine preventable disease but rotavirus gastroenteritis causes an estimated 329,000 hospitalizations and 4,900 deaths in infants and children each year in China. Almost 16 million babies are born in China annually and like all newborns the world over are at risk of rotavirus infection which can cause life-threatening diarrhea.



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