Headquartered in Japan, Takeda Pharmaceutical Company Ltd. is the largest pharmaceutical company in Asia and is speeding up development of a vaccine for dengue fever—a mosquito-borne flavivirus disease.1 The Japanese drugmaker has initiated a 20,000 patient based Phase 3 study in Asia and Latin America to test its TAK-003 experimental dengue vaccine.1
As part of the push to bring the new dengue vaccine to market, Takeda announced in November that it is building a $106 million plant at its manufacturing site in Singen, Germany.1 Plans call for completing construction by 2019.
The Aedes aegypti mosquito is the primary transmitter of the dengue virus and lives in hot and humid urban and semi-urban areas and breeds in containers. This mosquito, which also transmits yellow fever, chikungunya and Zika virus, formerly was only prevalent in Asia and Latin America but now is found in many countries with warm climates. Humans with or without symptoms can be carriers of the dengue virus and transmit it to others, as well as serve as a source of infection for uninfected mosquitoes.2
In the U.S., there have been sporadic reported cases of dengue fever in Hawaii and Florida. According to the World Health Organization (WHO), in 2015 there were 2.35 million cases of dengue reported in the Americas, including 1181 deaths.2
Dengue fever in infants, children and adults causes a flu-like illness that lasts about a week and rarely is fatal. Symptoms include high fever, severe headache, pain behind eyes, swollen glands, nausea and vomiting, skin rash, muscle/joint pain and skin rash. The symptoms begin manifesting about three to 14 days after a bite by a mosquito infected with the dengue virus.
There is a less than one percent mortality rate if appropriate rehydration therapy and care is given to avoid complications, which are manifested by rapid breathing, severe abdominal pain, bleeding gums and persistent vomiting with blood in vomit that can lead to respiratory distress, internal bleeding, damage to organs and death.
Dengue has become a more common infectious disease, particularly in tropical and subtropical regions of the world.3
Takeda’s Global Dengue Program medical director, Derek Wallace, states,
As an organization, we have a history of vaccine sales in Japan. But in order to be a vaccine company with a global global footprint, we’ve needed to build a team with significant experience in vaccine development and manufacturing. This Phase III demonstrates that we have that.3
Currently there are five different kinds of dengue vaccine candidates that are undergoing clinical trials, including live-attenuated vaccines, subunit, DNA and purified inactivated vaccine candidates.4
Sanofi Pasteur developed the first dengue vaccine, Dengvaxia (CYD-TDV), in 2015. Vaccine market analysts estimate that Dengvaxia could generate more than $1 billion in sales revenue for Sanofi by 2020.5
The WHO states that dengue is the fastest spreading mosquito-borne viral disease and that “about half of the world’s population is now at risk,” with dengue outbreaks or epidemics reported in over 100 countries resulting in 50-100 million human dengue infections per year.
Based on these statistics and dire predictions by public health officials, Takeda sees healthy market potential for sales of its dengue vaccine now in development.1
1 Palmer E. Takeda to Build $106M Vaccine Plant for Dengue Vax Push. FiercePharma.com Nov. 30, 2016.
2 World Health Organization. Dengue and Severe Dengue. July 2016.
3 MedGadget. Dengue Vaccines Market Globally Expected to Drive Growth through 2026. MedGadget.com Dec. 2, 2016.
4 Sagonowsky E. Takeda’s Hefty Dengue Ph III Displays a Vaccine Unit with New “Global Footprint”, Exec Says. FiercePharma.com Nov. 15, 2016.
5 MacDonald G. Takeda building Dengue fever vaccine plant. BioPharma Dec. 1, 2016.