Bayer has temporarily suspended global sales of its blood loss agent Trasylol pending a full evaluation of data from a Canadian Phase III study that was halted last month on safety concerns.

The move follows requests from health authorities in the USA, Canada and Germany that marketing be suspended until final data from the BART trial - an independent randomised, controlled study assessing the drug in high-risk cardiac surgery patients – become available for assessment.

In September, a Food and Drug Administration panel voted that Trasylol (aprotinin) - which is used to reduce blood loss during heart surgery - should remain on the US market despite studies suggesting that it doubled the risk of kidney failure and could also increase the risk of death.

But, in October, the US Food and Drug Administration announced its intention to take another look at the drug following a data safety monitoring board’s recommendation to halt patient enrolment in the planned 3,000-patient BART study, after preliminary findings indicated a higher risk of death compared to two antifibrinolytic drugs used in the study, epsilon-aminocaproic acid and tranexamic acid.

Full results in eight weeks
Once the complete dataset from this trial is available, which is expected take around two months, Bayer says it will work with health authorities to assess whether there is any impact on the positive benefit-risk assessment for Trasylol and if it should remain on the market. But the company stressed that it “believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labelling”.

The firm says that health authorities have indicated their interest in creating a program that would allow the use of Trasylol in certain surgical patients “with an established medical need”, especially as there is no other anti-bleeding product specifically approved for use in cardiac surgery.

So what does this mean for Bayer? Well, estimated sales of Trasylol for the first three quarters of 2007 are around 93 million euros and, according to media reports, analysts seem fairly confident that, even if the drug were pulled from all markets, the impact on Bayer would not be great, especially as the small patient population means that the risk of any resultant litigation is low.

Positive third quarter
Meanwhile, the company has booked third-quarter sales of nearly 7.8 billion euros, marking growth of 4.5% over the year-earlier period, and is predicting record growth for the full year.

Despite adverse shifts in exchange rates and high raw material prices, earnings before interest, taxes, depreciation and amortisation and before special items climbed 6.9% to 1.5 billion, and the operating result – earnings before interest and tax – and special items jumped 23.9% to 953 million euros.

Full details of Bayer’s third-quarter performance will follow tomorrow from our reporter attending the results conference in Germany.