Baxter has officially opened its $370m manufacturing facility for haemophilia A drug Advate in Singapore, shortly after getting EU approval for the plant.
EU approval of the Singapore plant allows it to process and supply Advate to the EU, Iceland and Norway, and as additional regulatory approvals come in Baxter will use the facility to serve additional markets, including the Asia-Pacific region.
Advate is the leading recombinant Factor VIII product in the market and has been growing strongly – despite looming competition in the haemophilia A market – thanks to its continued roll-out in emerging markets such as Brazil, Turkey and Russia and also on the back of new tender wins in the UK and Australia that will boost market share.
The new plant boosts Baxter’s production capacity for Advate by 50 per cent and will also be used to produce other recombinant proteins in the company’s pipeline – including recombinant Factor IX product Rixubis for haemophilia B – when a second processing suite is added in the coming months.
Rixubis (formerly BAX 326) debuted in the US last year and became the first new Factor IX drug on the market with labelling covering both prophylaxis and control. It was filed for approval in the EU later that year.
The plant will also support production of Baxter’s extended half-life recombinant Factor VIII treatment BAX 855, which aims to defend the company’s haemophilia A franchise from long-acting rivals such as Biogen Idec’s Eloctate, which has just reached the market, and Bayer’s BAY94-9027 which is in late-stage development.
Around 400 staff are currently employed at the Singapore unit, with another 50 expected to be added when the second processing suite comes online in 2015.
Baxter recently announced it will separate its $6bn-a-year biopharmaceuticals business from its medical products arm, in a manner reminiscent of the earlier break-up of Abbot to form AbbVie, in order to allow the units to respond to “diverging business dynamics.”
The separation of the two units will allow the biopharma division to trim its focus on core areas – Baxter has also recently hived off vaccine assets to Pfizer – as well as boost growth and profitability and expand its manufacturing network to serve emerging markets.