Adimmune Corporation announced that as part of strategic collaboration with Techdow Pharmaceutical for the European market, it has obtained approval for the manufacturing of enoxaparin sodium pre-filled syringes in Poland and elsewhere in the European Union,
The company has also announced that it begun quadrivalent influenza vaccine phase III trial in Europe.
Adimmune has already received orders from Techdow for enoxaparin pre-filled syringes (PFS) and commercial-scale manufacturing has begun. The first commercial batch shipment will commence in January 2017. The collaboration between Adimmune and Techdow began in 2013 with Techdow providing enoxaparin API while Adimmune provides a pre-filled syringe filling service, and ships to Europe. Approval has been obtained after three years of trial manufacturing and site inspections. The demand for enoxaparin sodium is strong in Europe and Adimmune expects the utilization rate of its PFS production line to ramp up quickly after mass production, boosting 2017 top-line growth. At 10M, overall 2016 revenue is up 81% for Adimmune and growth momentum is expected to continue as this new product starts shipping in 2017.
In October, Adimmune initiated its quadrivalent influenza vaccine phase III trial in Europe. The recruitment of participants is going well with over 1,000 participants enrolled in the programme. It is expected that the recruitment process will be completed by the end of 2016. Adimmune will begin the process for a Biologics License Application (BLA) in 2017. This is the largest clinical trial in Europe initiated by a Taiwanese vaccine company, and a milestone for Adimmune to begin selling its own-brand product in Europe.
Adimmune is the No.1 flu vaccine provider in Asia to obtain US, EU, China and Taiwan cGMP, and will obtain Japan cGMP in 2017. The company has ample capacity in flu vaccine of 25mn doses/year and pre-filled syringe (PFS) of 25mn doses/year. Its solid capability in high-quality commercial scale human vaccine manufacturing has enabled Adimmune to expand its business to China, Europe, Japan and the US. Currently Adimmune is the largest provider of flu vaccine (3 strains) and sole provider of Japanese Encephalitis vaccine and Tetanus vaccine in Taiwan.