OSAKA -- Mitsubishi Tanabe Pharma is developing a process that uses tobacco leaves to produce influenza vaccines within one month -- a sixth of the time typically needed.
The technique will be put into commercial use as soon as fiscal 2018 or 2019. Mitsubishi Tanabe has all but finished verifying the safety and effectiveness of the vaccines in the U.S. and Canada. The inoculations are set to undergo final clinical trials in the U.S. by the end of this year.
The company "will first do business in the U.S., and we will also consider Asian countries if we meet profitability goals," said President Masayuki Mitsuka.
Normally, the flu viruses used for vaccines are cultured using chicken eggs. Those viruses are made inactive before injection. However, the approach takes half a year to produce vaccines, making it difficult to create the most effective vaccine for a particular flu season.
Other methods can shorten the production time to roughly three months, including one that uses insect cells to incubate viruses.
Mitsubishi Tanabe will use technology developed by Canada's Medicago, a company it acquired in 2013. The technology implants genetic material into the leaves that produces flu-like particles containing antigens, which trigger immune responses. Because the particles are not live flu viruses, chances of infection are minimal.
Tobacco is cheap, grows quickly and produces a sizable yield of leaves, making it an ideal incubator for vaccines. Speedy mass production of flu vaccines will enable more people to become inoculated during pandemics.
Clinical trials are also being conducted for bird flu and H7 influenza vaccines produced from tobacco leaves. In addition, the company is developing vaccines for rotavirus, which causes severe diarrhea, and for rabies using the same technique.
Quality control will be easier since the vaccines will be made in greenhouses and similar structures, and production costs will likely shrink.
In Japan, Mitsubishi Tanabe is partnering with Osaka University's Research Institute for Microbial Diseases in selling flu vaccines. However, there are severe restrictions on production processes inside Japan.
Because the new process uses genetic manipulation, Japanese standards will have to be revised, which will delay commercialization of the technique. For those reasons, Mitsubishi Tanabe chose the U.S. as the first market for the vaccine.
The Japanese company is aiming for 80 billion yen ($702 million) in U.S. sales by fiscal 2020, according to last year's medium-term plan. As a key driver for that goal, the vaccine is projected to sell tens of billions of yen every year.