Japanese pharmaceutical company Takeda and US-based Frazier Healthcare Partners have announced a collaboration to launch HilleVax, Inc., a biopharmaceutical company to develop and commercialize Takeda’s norovirus vaccine candidate.

Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales.

Takeda will retain commercialization rights in Japan and HilleVax will integrate certain Japan development activities into its global development.

Takeda remains committed to vaccines, and this collaboration allows it to focus its global resources on dengue, COVID-19, pandemic influenza and Zika, in addition to the vaccines it currently distributes in Japan.

HIL-214, which is a virus-like particle (VLP) based vaccine candidate, completed a randomized, placebo-controlled Phase 2b field efficacy study in 4,712 adult subjects in which HIL-214 was well-tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of acute gastroenteritis from norovirus infection. 

Norovirus is a common intestinal infection marked by diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration. 

No vaccines are currently approved for norovirus infection, and HIL-214 continues to be the most advanced norovirus vaccine candidate in human clinical trials.