As Takeda prepares to launch its dengue vaccine after a decade in development, there are many more uncertainties than with the launch of a traditional commercial product.
Nevertheless, the Tokyo-based company is expanding its manufacturing capacity for Qdenga in anticipation of strong demand, CEO Christophe Weber said Monday afternoon at the annual J.P. Morgan Healthcare Conference.
Takeda has been gearing up for a while. In 2016, the company revealed its plan to build a 100 million euro ($106 million) plant in Singen, Germany, dedicated entirely to production of the two-shot vaccine. Components of the vaccine are currently manufactured at the site and by 2025 it will be used for end-to-end manufacturing, a company spokesperson said Tuesday. In the meantime, Takeda is also using a contract manufacturer.
With its new launch, Takeda is entering territory that is somewhat unfamiliar as the rollout will feature private and public markets.
“When the public market will kick off and how it will happen, we have to see that,” Weber said.
Takeda is more certain about the private market, which includes travelers from developed countries to those where dengue is endemic.
Takeda also is uncertain about Qdenga's potential as a commercial product, assigning Qdenga wide range of peak sales—between $700 million and $1.5 billion.
The vaccine is set to launch imminently in Indonesia. Launches in several endemic countries around the world are expected to follow after the EU signed off on the shot last month. Meanwhile, in November, Qdenga received priority-review designation from the FDA. The company expects an FDA decision in the first half of this year, according to the company spokesperson.
A key advantage of Qdenga is its ability to provide protection for 4.5 years—“not six months, like some recent vaccines,” Weber quipped. Another is that, unlike previous dengue vaccines, Qdenga can be used regardless of prior exposure to the virus. This is important because it is often difficult to determine whether patients have prior exposure as first-time infections are typically mild and often mistaken for the flu.
Dengue has appeared in more than 125 countries and is one of the primary causes of hospitalization in children in many parts of the world. The EU approval is for adults and children aged 4 and older. The nod in Indonesia is for people ages 6 through 45.
"When you have a dengue flair in your country, everybody is going to hospitals," Weber said. "Many of the dengue endemic countries are comparing dengue with COVID. They are living with this type of public health disruption."
Sanofi was first with a vaccine for dengue. But its launch of Dengvaxia in the Philippines was derailed in 2017 when the company revealed that the shot could cause more serious dengue infection if given to patients who had never contracted the virus.
“We believe we have a very strong proposition here for all endemic countries. There are 4 billion people living in endemic countries in the world,” Weber said.