Takeda taps Biological E to ⁠ramp up Qdenga manufacturing capacity on quest to make 100M doses a year

With a new manufacturing partnership in India, Takeda has added new firepower to its stated goal of producing 100 million doses of dengue fever vaccine Qdenga annually by the end of the decade.

Takeda linked up with India’s Biological E. Limited (BE) to speed up access to Qdenga. The new partner will produce multi-dose vials that will be ready for endemic countries to buy by 2030 “at the latest”, the Japanese drugmaker said in a release.

The multi-dose vials offer several advantages for national vaccine programs, Takeda explained, including cutting packaging and storage expenses.

Under the deal, BE will scale up to a manufacturing capacity of 50 million doses a year, helping Takeda move toward its effort to produce 100 million doses annually. Takeda, for its part, manufactures the vaccine at its Singen, Germany, facility and through its long-time partnership with CDMO IDT Biologika GmbH.

The India-based manufacturer has “deep expertise” in vaccine manufacturing and “longstanding support of public health programs around the world,” the head of Takeda’s global vaccine business unit, Gary Dubin, M.D., said in the release.

So far, the company has launched Qdenga in Indonesia, Thailand, Brazil and Argentina, plus certain European markets. There has been “strong initial demand” in private markets, Takeda said in an earnings presentation earlier this month.  

The vaccine has made it onto some government immunization programs, including in Brazil. The company has engaged in “productive discussions” with governments in other endemic regions to add the shot to their national immunization programs, Takeda added in its presentation.

Meanwhile, Takeda pulled its FDA bid last year after the agency requested additional data that the drugmaker figured it couldn’t produce within the review cycle.

At the time, the company said its future plan for the U.S. would be “further evaluated” given the need for travelers and those in dengue-endemic areas of the U.S. such as Puerto Rico.

The company has pegged its peak Qdenga sales projection at $1.6 billion to $2 billion. After generics hit Takeda's popular attention-deficit/hyperactivity disorder (ADHD) drug Vyvanse last year, Takeda will rely more on Qdenga and other recent launches to pick up the slack.