Baxalta Singapore plant gets FDA OK to produce Advate hemophilia product

The hemophilia A treatment Advate is the cornerstone to the future of Baxalta ($BXLT), the company that was created when Baxter International ($BAX) spun off its drug operations in July. Now the newbie will be able to produce more of the product at a plant in Singapore it opened just last year.

Baxalta announced today that the FDA has approved its biologics plant in Singapore to manufacture the bulk drug substance for Advate. The company said the approval followed an inspection in which the FDA had no observations.

The fact is, the plant has been producing bulk product there for Advate for nearly two years after its approval in January 2014 by the European Medicines Agency to manufacture for the EU market. Advate is the world's most prescribed Factor VIII-replacement therapy and Baxalta's biggest seller at nearly $2 billion.

The company said in a release that the approval will allow Baxalta to grow its global Factor VIII portfolio, "including Advate and additional investigational treatments, identical in each Baxalta manufacturing facility in which it is produced."

Spokesman Geoffrey Mogilner said today in an email that the immediate plan is to only produce the Advate BDS at the Singapore facility, but "our longer-term plan is to produce multiple products at the Singapore facility."

One of those products is expected to be Baxalta's follow-up, long-acting version of Advate, which was approved by the FDA just yesterday. The injection, to be marketed as Adynovate, replaces the missing coagulation protein to blame for certain types of hemophilia. Advate is under pressure from newer drugs from Novo Nordisk ($NVO) and Biogen ($BIIB).

Baxalta also found itself immediately under pressure from Shire ($SHPG), which offered to buy the Bannockburn, IL-based drugmaker for about $30 billion to get its hands on Baxalta's $3.4 billion hemophilia portfolio. Baxalta has refused the offer as too low and says its future is fine in it own hands.

- here's the release

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