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Baxter 'will file long-acting haemophilia drug by year-end'

New version of Advate clears late-stage trial
Baxter building

A long-acting version of Baxter's haemophilia A therapy Advate has cleared a phase III trial, setting up regulatory filings before the end of the year.

BAX 855 is a pegylated form of Advate, which is currently the leading recombinant Factor VIII product in the market but is facing competition from longer-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.

Baxter's new drug was tested in the 138-patient study as both a preventive therapy and for on-demand treatment of haemophilia A in people aged over 12, with the aim of reducing bleeding rates compared to on-demand treatment alone.

The primary measure in the trial was the annualised bleeding rate, with BAX 855 achieving a median of 1.9 bleeds over 12 months compared to 41.5 in the on-demand group. The long-acting drug was also able to manage bleeding episodes, tackling 96 per cent of cases with one or two infusions.

No patient in the study developed inhibitors to BAX 855, and there were no reports of treatment-related serious adverse effects, such as hypersensitivity, said Baxter.

"The positive results of the BAX 855 study reflect our ongoing, long-term commitment to drive innovation and expand treatment options for patients with haemophilia," commented Baxyer BioScience R&D head John Orloff.

Baxter recently announced it will separate its $6bn-a-year biopharmaceuticals business from its medical products arm. In July the company raised the financial forecasts for its haemophilia franchise, despite the competition from Biogen Idec which also includes a long-acting haemophilia B therapy - called Alprolix - that will compete with Baxter's recently-approved Rixubis.

Baxter will file BAX 855 initially in the US, and is also conducting a 60-patient study of the drug in 60 children aged under 12 that will be required before it can move ahead with a marketing application in Europe.

22nd August 2014

From: Research, Sales

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