TOKYO – Takeda Pharmaceutical Co. Ltd. said its TAK-214 vaccine, the world’s first to tackle the Norovirus, is now in phase IIb field efficacy trials.
Targeting norovirus, the vaccine could open up a huge market for Takeda, of Osaka, Japan. There are an estimated 700 million cases of illness related to the virus recorded annually across the world. In poorer countries, the virus can damage people’s lifestyles significantly or prove fatal. It leads to more than 200,000 deaths a year, according to researchers.
The trials will involve healthy adults ages 18-49 and evaluate the intramuscular administration of the vaccine against moderate or severe acute gastroenteritis due to norovirus. It will be double-blind, randomized and placebo-controlled.
“The trial has just started, and will continue to enroll [volunteers] until the target number of cases is recorded,” said Elissa Johnsen, head of product and pipeline communications at Takeda.
If the trial is successful, “approval for the vaccine will be sought in the U.S., Canada, Europe, Japan and other geographies based on disease burden and medical need,” said Johnsen.
The announcement comes after Takeda purchased Ligocyte Pharmaceuticals Inc. for $60 million with future contingent considerations based on development and Inviragen Inc. for $35 million with future payments of up to $215 million.
“Our acquisition of Ligocyte Pharmaceuticals  and Inviragen  enhanced Takeda’s core vaccine research and development capabilities and helped further establish a vaccine research and development presence,” Johnsen said.
Speaking of the new phase of trials, Robert Goodwin, vice president and global norovirus program head for Takeda Vaccines, praised the efforts of collaboration between different parts of the Takeda Group.
“Together with our collaborators, Takeda has dedicated a substantial scientific effort to understand the best ways to prevent norovirus illness through vaccination,” he said. “This trial moves us one step closer to putting an important tool for prevention in the hands of individuals, families and public health systems around the globe.”
Takeda’s new vaccine covers two genogroups that are responsible for the majority of human illnesses. In initial studies, the vaccine was shown to be clinically effective, according to the Osaka, Japan-based company.
“Results from phase I and phase II studies showed the candidate is generally well tolerated and had a clinically relevant impact, as defined by a reduction in disease symptoms and severity in a human challenge study,” said Johnsen.
The company filed with the U.S. government to conduct the new trial on Jan. 27. Estimated enrollment for the trial is 3,400 participants, with study completion expected around December 2017. The primary completion date is expected in August of the same year.
Trials will be on applicants from anywhere in the world, and will take place at an undisclosed U.S. Navy location in the U.S.
With the vaccine still far from the market, the company has yet to decide on strategies for releasing it if it proves successful, or pricing.
“It is premature to discuss the regulatory strategy or timetable for the norovirus vaccine,” Johnsen said. “It would [also] not be appropriate to comment on price at this time.”
Takeda has a number of other vaccines in the pipeline for illnesses such as dengue fever, polio, and hand, foot and mouth disease. Rajeev Venkayya, president of Takeda Vaccines, said that the progress in developing the norovirus vaccine “demonstrates our commitment to tackling important infectious diseases that affect populations everywhere.”
As well as vaccines, Takeda has drugs in the pipeline for oncology, gastroenterology, central nervous system diseases, diabetes and other ailments. “Takeda has built a strong pipeline that is relevant to developed and developing countries.”
Takeda’s shares opened the week at ¥4,378 (US$42.53) and closed at ¥4,132, much more affected by the decision by voters in Britain to opt out of the European Union than by the announcement of of the new norovirus vaccine trial. The company’s shares started the year worth ¥5,917, but have declined in tandem with the Japanese stock market, which has over the course of the year seen foreign money pulled out at the same time as the yen has strengthened through a period of economic uncertainty.