Adimmune

News

2016-11-23

Adimmune begins shipments to EU and Phase III trial in Europe

TAIPEI,Taiwan, Nov. 23, 2016 /PRNewswire/ -- Approval has been obtained for themanufacturing of Enoxaparin Sodium pre-filled syringes in Poland and elsewherein the European Union, as part of a strategic collaboration with AdimmuneCorporation (4142 TW) and Techdow Pharmaceutical for the European market.Separately, the company has also begun its Quadrivalent Influenza Vaccine PhaseIII trial in Europe.

EnoxaparinSodium Pre-filled Syringe shipments: Adimmune has already received orders fromTechdow for Enoxaparin pre-filled syringes (PFS) and commercial-scalemanufacturing has begun. The first commercial batch shipment will commence inJanuary 2017. The collaboration between Adimmune and Techdow began in 2013 withTechdow providing Enoxaparin API while Adimmune provides a pre-filled syringefilling service, and ships to Europe. Approval has been obtained after threeyears of trial manufacturing and site inspections. The demand for EnoxaparinSodium is strong in Europe and Adimmune expects the utilization rate of its PFSproduction line to ramp up quickly after mass production, boosting 2017top-line growth. At 10M, overall 2016 revenue is up 81% for Adimmune and growthmomentum is expected to continue as this new product starts shipping in 2017.

PhaseIII trials begin: In October, Adimmune initiated its Quadrivalent InfluenzaVaccine Phase III trial in Europe. The recruitment of participants is goingwell with over 1,000 participants enrolled in the program. It is expected thatthe recruitment process will be completed by the end of 2016. Adimmune willbegin the process for a Biologics License Application (BLA) in 2017. This isthe 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.

AboutAdimmune: 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 hasample 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 humanvaccine manufacturing has enabled Adimmune to expand its business to China,Europe, Japan and the US. Currently Adimmune is the largest provider of fluvaccine (3 strains) and sole provider of Japanese Encephalitis vaccine andTetanus vaccine in Taiwan. Adimmune is listed on the Taiwan Stock Exchange(4142 TT).