TAK-003 (Takeda) is a needle-free, tetravalent live-attenuated vaccine currently in Phase II/III development in the US and dengue-endemic countries in Asia and Latin America, including Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Peru, the Philippines, Sri Lanka, Thailand, and Vietnam.
TAK-003 is expected to gain approval approximately four years behind Dengvaxia (tetravalent live-attenuated chimeric vaccine; Sanofi Pasteur), but has the potential to supersede its rival if it is able to provide comparable protection with shorter single-dose or two-dose schedules. The inclusion of the dengue virus serotype 2 (DEN-2) non-structural genes within TAK-003 could also be a major differentiator if it results in improved protection against DEN-2 strains. However, TAK-003’s launch after the anticipated conclusion of one-off adolescent vaccination catch-up campaigns in wealthier endemic markets, and its possible exclusion from the public sectors of Latin American markets due to the importation of low-cost TetraVax-DV (tetravalent live-attenuated chimeric vaccine; Biological E/Panacea Biotec/Butantan Institute/Merck & Co/Vabiotech) from Brazil, have significantly lowered the vaccine’s public sector commercial potential. Takeda may therefore seek to divert a significant percentage of its vaccine supply to the military and traveler segments in non-endemic markets, where a single-dose schedule would be very competitive and a higher price per dose could be achieved.
TABLE OF CONTENTS
4 Product Profiles
4 TAK-003 : Dengue vaccines
LIST OF FIGURES
6 Figure 1: Design of the TAK-003 vaccine
13 Figure 2: TAK-003 for dengue fever – SWOT analysis
LIST OF TABLES
5 Table 1: TAK-003 drug profile
7 Table 2: TAK-003 completed studies in dengue fever
11 Table 3: TAK-003 ongoing studies in dengue fever
12 Table 4: TAK-003 Phase II trial data in dengue fever
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