Bayer to seek approval for haemophilia drug this month

[December 02, 2014]  FRANKFURT (Reuters) - Drugmaker Bayer AG said on Tuesday it will this month file for approval of its experimental haemophilia drug Bay 81-8973, based on its established Kogenate brand, as it seeks to build a range of treatments against the hereditary bleeding disorder.

The German company in March unveiled plans to spend more than 500 million euros ($622 million) to set up haemophilia drug production sites in Germany, in a sign of confidence in its development pipeline.

Patients have seen new treatment options and more are in the offing. U.S. regulators earlier this year approved Biogen Idec's long-lasting haemophilia A drug Eloctate and hemophilia B treatment Alprolix, both co-developed with Swedish Orphan Biovitrum AB.

Novo Nordisk has two long-acting drugs against type A and B in the third and last phase of testing required for regulatory approval.

Bayer's established haemophilia A therapy product Kogenate, had 1.2 billion euros ($1.5 billion) in sales last year.

Apart from Bay 81-8973, which Bayer aims to bring to U.S. and European markets, the company has another drug candidate against the type A of the bleeding disorder in the third and last phase of testing.

Bayer has previously said it expects to seek approval for this drug, known as Damoctocog alfa pegol, in mid-2016.

People with haemophilia have a fault in a gene that regulates the body's production of proteins called clotting factors. This can cause spontaneous bleeding as well as severe bleeding following injuries or surgery.

(Reporting by Ludwig Burger; Editing by Maria Sheahan)

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