Japanese groups Astellas Pharma and UMN Pharma have entered into a memorandum of understanding to co-develop and exclusively commercialise the latter’s the cell culture-based influenza vaccine programmes UMN-0501 and UMN-0502.
UMN-0501 is a cell culture based H5N1 avian influenza vaccine that was granted orphan drug status in June 2008. Phase I/II and Phase II clinical trials have been successfully completed in Japan, “with both immunogenicity and safety identified,” and preparations for Phase III testing are underway, according to the firm.
UMN-0502 is a cell culture based seasonal influenza vaccine based on three different antigens, which will be tested in a Phase I/II clinical train programme in Japan shortly. The companies said they expect to launch both vaccines by the end of fiscal year 2014.
Under the terms of the understanding, Astellas has been granted co-development and exclusive commercialization rights for the programs in Japan, and as such will lead further development and carry all costs. UMN Pharma retains responsibility for manufacturing. Financial specifics were not unveiled.
The move falls in line with Astella’s recently announced commitment to strengthen its vaccines business in Japan, and the group said that the impact of the deal is “immaterial” to its forecasts for the current fiscal year.