With flu season in full swing, Mitsubishi Tanabe has its eyes on the horizon as it aims to get its quick-to-produce, tobacco-based flu vaccine on the market by 2018 or 2019. Nikkei Asian Review reported on Tuesday that the Osaka-based company has "all but finished" safety and efficacy trials of the vaccine in the U.S. and Canada and plans to run late-stage trials by the end of the year.
Mitsubishi Tanabe is developing the vaccine using technology obtained in its 2013 acquisition of Quebec City-based Medicago. Genetic material from the flu virus is implanted into tobacco leaves, which then produce flu-like particles containing antigens to provoke an immune response, Nikkei reported. The process takes one month to produce a vaccine, compared to the 6 months required to produce a traditional egg-based jab. Another plus is that tobacco grows quickly and produces a large yield of leaves, so vaccines can be made quickly and in large amounts.
If approved, these advantages could give Mitsubishi Tanabe's vaccine a leg up over traditional flu vaccine makers, including GlaxoSmithKline ($GSK) and Sanofi ($SNY), which both market egg-based jabs. Because these vaccines take 6 months to make, health authorities must decide far in advance which strains to include in them. This can lead to strain drift, where the vaccine strains differ from the strains that actually circulate.
Mitsubishi Tanabe plans to enter the U.S. market and "will also consider Asian countries if we meet profitability goals," President Masayuki Mitsuka said, as quoted by Nikkei. The company is unable to move forward in Japan as of yet because of strict rules on production processes that will not allow the commercialization of a vaccine that uses genetic manipulation. "Japanese standards will have to be revised," delaying commercialization of vaccines produced using this technology in Japan, Nikkei reported.
Other vaccine makers seeking to develop faster methods to make flu vaccines include Cranbury, NJ's VaxInnate and Gaithersburg, MD-based Novavax ($NVAX), which are both working on recombinant jabs. Novartis ($NVS) won approval in 2014 to grow flu virus in cells instead of eggs, which shaves about four weeks off the manufacturing process, but then sold its flu vaccine business to Australia's CSL ($CSL) last year. And in November, Sanofi announced a new collaboration to create a "universal" vaccine through the genomic sequencing of flu viruses, which would address strain mismatch.
- read the Nikkei Asian Review story