Medigen Vaccine Biologics. Co (MVC) enters a license agreement with US National Institute of Health (NIH) on November 17th to develop, make, sell and sublicense NIH’s live attenuated dengue vaccine in 17 countries, including Taiwan, Korea, Australia, India, 7 Southeast Asian countries1 , and 6 countries2 in Middle East.
The vaccine was developed by Dr. Stephen Whitehead’s laboratory in NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and was licensed to other institutions, including Butantan Institute in Brazil and Merck in North America and Europe. Among all licensees, MVC obtains market rights in Southeastern Asia, Middle East and India, regions covering 1/3 of global population with highest dengue incidence rate.
NIH’s vaccine elicits robust antibody and cellular immune response against all 4 DENV serotypes with just only 1 dose. In March 2016, NIH further announced a human challenge study result, indicating vaccinated volunteers are 100% protected while the placebo group developed viremia and/or rash after being exposed to a genetically-modified type 2 dengue virus. Based on the study, a phase 3 clinical trial sponsored by Butantan was initiated in Brazil this year, enrolling near 17,000 healthy subjects aged 2 to 59 years old. The trial will provide more solid safety and efficacy data to expedite global marketing.
After entering agreement with US NIH, MVC will initiate consultation with national regulatory authorities to conduct a local clinical trial in Taiwan, followed by a multi-regional clinical trial in target market. With EV71 and mock-up vaccines under clinical development, MVC strives to become one of the leading pharmaceutical companies to prevent emerging tropical infectious diseases.
1. 7 South-Eastern Countries: Philippines, Indonesia, Vietnam, Thailand, Malaysia, Singapore and Pakistan.
2. 6 Middle-Eastern countries: Saudi Arabia, United Arab Emirates, Kuwait, Bahrain, Oman, Qatar.