Hilleman Laboratories announces strategic collaboration with Gotovax AB to develop next generation Oral Cholera Vaccine
Aims to offer OCVs at a significantly more affordable price than the ones currently
available in the market for developing countries
First-of-its-kind partnership undertaken to address unmet needs of the Cholera disease
burden in highly endemic areas like Bengal delta, Africa
Demand for vaccine is expected to sharply increase in Cholera endemic countries
Hilleman Laboratories' thermostability technology to facilitate stockpiling in diverse
geographies
New Delhi, June 17, 2014: Hilleman Laboratories, an equal joint-venture partnership between Merck &
Co., a global research-driven pharmaceutical company and Wellcome Trust, a global charitable foundation,
today announces its strategic collaboration with Gotovax AB, a University of Gothenburg spin-off
biopharmaceutical company, to develop a high impact Oral Cholera Vaccine. With this collaboration,
Hilleman Laboratories aims to deliver the vaccine at a significantly more affordable price than the ones
currently available in the market. Easy to administer, with cross protection against ETEC diarrhea and
enhanced with a longer shelf life; this vaccine candidate will be most suited for geographies with the highest
cholera burden like Africa and South Asia.
"Cholera is endemic in over 50 countries with estimated mortality
of 100,000-120,000 deaths and a morbidity of 3.8-4.4 million
annual cases attributed to this disease. There is an urgent need
of highly effective and affordable Cholera vaccines both for
outbreaks as well as mass vaccination campaigns. Our
partnership with Gotovax AB is carefully aligned to Hilleman
Laboratories' core philosophy of addressing unmet health needs
of the underprivileged by developing accessible and innovative
vaccines which are affordable," said Dr. Davinder Gill, CEO,
Hilleman Laboratories.
"We expect our vaccine to significantly reduce the burden of
disease thanks to our lower price, increased thermostability and
reduction of projected gap in supply by current manufacturers,"
added Dr. Gill.
The huge Cholera burden has led to a demand for an effective, low-cost Cholera vaccine for use in epidemic
outbreaks as well as for mass vaccinations in endemic settings. A market also exists for travelers to
endemic regions. Demand estimates for Cholera vaccines vary significantly across scenarios with an
expected 30 million doses needed by 2016 rising to expected 200 million doses by 2025, assuming
vaccination of all 1-14 year old patients in high risk populations. Global public health community has also
expressed concern that current Cholera vaccine manufacturers may not be able to meet the projected
increase in demand further strengthening the requirement for alternate, low-cost vaccine supply.
Explaining the uniqueness of this vaccine candidate, Prof. Jan Holmgren, MD, PhD, CEO, Gotovax AB and
Director of the University of Gothenburg Vaccine Research Institute, said "Cholera is caused from enteric
infection with the bacterium Vibrio cholerae primarily (~99%) of the O1 serotype. By transferring a functional
wbeT methyl transferase gene into the genome of an O1 Inaba strain we have created a resulting "Hikojima"
strain that stably expresses both the Ogawa and Inaba serotype antigens on its surface; thus improving the
stability and efficacy of the vaccine candidate as well as significantly reducing the cost of production."
Dr. Gerd Zettlmeissl, Chairman of Board of Directors, Hilleman Laboratories said, "We are very excited
about this collaboration and intend to make a significant contribution towards addressing the Cholera
disease burden in developing countries. This program complements our ongoing efforts in the development
of an oral thermostable Rotavirus vaccine and strengthens our vision of building a portfolio of enteric
vaccines."
Under this agreement, Hilleman Laboratories gains world-wide exclusive rights to the vaccine candidate
developed at the University of Gothenburg. Hilleman Laboratories will further develop the vaccine and will
be responsible for conducting clinical studies towards successful licensure and commercialization. The
clinical development strategy will initially center on prevention of clinically severe Cholera and interruption
of transmission during Cholera outbreaks. The clinical studies will be conducted to assess safety and
immunogenicity in a small cohort of adults, followed by children, toddlers and infants down to 1 year of age
in a phased manner.
Hilleman Laboratories plans to collaborate with leading research institute(s) in the field of enteric diseases
for clinical development, and with vaccine manufacturing organizations in developing countries for large
scale manufacturing and distribution.
About Hilleman Laboratories
Hilleman Laboratories is a first-of-its-kind joint-venture partnership formed between Merck & Co., a global research-driven pharmaceutical organization and Wellcome Trust, a global charitable foundation dedicated to human and animal health by supporting the brightest minds.
Hilleman Laboratories has been named after renowned scientist and father of modern vaccines Dr. Maurice Hilleman. His dedication to making a difference through the practical application of vaccine research and delivering vaccines to people most in need forms the core mission of Hilleman Laboratories.
Operating on a not-for-profit principle, Hilleman Laboratories aims to bridge the gap between early vaccine research and clinical proof of concept and become a preferred partner for Low Cost Vaccine Manufacturers for vaccine development and usage for public health in the developing world.
University of Gothenburg
The University of Gothenburg, Sweden is one of the largest universities in Scandinavia, with eight faculties, 37,000 students and 6,000 employees. Its health faculty - The Sahlgrenska Academy, hosts more than 1,500 researchers in experimental as well as clinical medicine. One of its sincelong recognized areas of international prominence its vaccines and vaccine-related immunology, especially mucosal vaccines against enteric infections, in which area it has established a special centre of excellence, University of Gothenburg Vaccine Research Institute (GUVAX).
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