Baxter has reported new phase III results for its long-acting haemophilia A treatment BAX 855 that place it on course for filing in the EU in early 2016.
The new drug – a pegylated version of Baxter’s recombinant Factor VIII product Advate – was submitted for approval in the US in December with a green light expected later this year.
The new data from Baxter’s pivotal trial of BAX 855 show that patients in the twice-weekly prophylaxis arm of the trial experienced a 95% reduction in the median number of bleeds over a year compared to those who were treated on-demand.
“These pivotal trial results provide evidence to support the efficacy profile of BAX 855 in controlling, preventing or reducing the frequency of bleeding episodes when administered prophylactically twice weekly,” said John Orloff, head of R&D at Baxter Bioscience.
The company will wait for the completion of an ongoing paediatric trial in patients under 12 years old before filing the long-acting version with the European Medicines Agency (EMA).
BAX 855 is seen as a critical new product for the company as it faces increased competition from Biogen Idec in its haemophilia franchise, particularly in the US where it recently predicted a “high single-digit” loss in market share and declining sales this year.
Biogen Idec’s long-acting rival Eloctate was launched onto the US market last summer and approved in Japan the following December, while Baxter could also see competition in the future from Bayer’s BAY94-9027 which is in late-stage development.
Fourth-quarter sales of all Baxter’s haemophilia products were up 9% to $1.1bn, suggesting the impact of Eloctate reaching the market was not as great as some had anticipated, although Baxter said its franchise was boosted by conversions of Advate patients from on-demand to prophylactic use and growing sales in emerging markets, notably Brazil.
Biogen Idec reported Eloctate sales of $58m last year, mainly from the US, and is several months ahead of Baxter in Europe as well as it has already filed for approval of the drug with the EMA.
Baxter will be able to supply the European market with BAX 855 made from its new manufacturing facility in Singapore, which was approved by the European Medicines Agency (EMA) towards the end of last year.