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09 Dec 16

Adimmune begins shipments to EU and Phase III trial in Europe

25 Nov 16

Approval has been obtained for the manufacturing of Enoxaparin Sodium pre-filled syringes in Poland and elsewhere in the European Union, as part of a strategic collaboration with Adimmune Corporation (4142 TW) and Techdow Pharmaceutical for the European market. Separately, the company has also begun its Quadrivalent Influenza Vaccine Phase III trial in Europe.

Enoxaparin Sodium Pre-filled Syringe shipments: 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.

Phase III trials begin: 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 program. 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.

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