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.
- Higher protection in the first six months in the range of 85-90%. Presence of rCTB provides cross protection against ETEC diarrhea.
- New vaccine candidate consists of a single genetically engineered host strain which will allow a significant cost reduction, thereby improving access.
- Easy to administer vaccine of 2ml or less. Eliminates the requirement of clean drinking water following intake.
- Hilleman Laboratories’ thermostable technologies will enhance stability of the formulation, making the vaccine more attractive for worldwide stockpiling purposes.