Bayer is confident that its new anticoagulant Xarelto is well-equipped to challenge rival product Pradaxa, despite the Boehringer Ingelheim drug having already gained US regulatory approval for a potentially-lucrative indication of stroke prevention.
Speaking at Bayer's annual press conference in Leverkusen earlier this week, chief executive Marijn Dekkers said that Xarelto (rivaroxaban) has peak annual sales potential of more than 2 billion euros. In January, it was filed for stroke prevention in non-valvular atrial fibrillation in the European Union and the USA and for the treatment and secondary prevention of deep vein thrombosis in Europe.
The 10 billion-euro stroke prevention market is particularly interesting but Bayer has to deal with the fact that Boehringer's Pradaxa (dabigatran etexilate) was approved for this indication in the USA last year. Dr Dekkers would not make any forecasts in terms of what market share the company is expecting but analysts are positive about its prospects as Xarelto benefits from once-daily dosing whilst Pradaxa is taken twice-daily.
Both drugs are available in a number of territories for a smaller indication, ie prevention of venous thromboembolism following elective hip or knee replacement surgery. Xarelto is available in 75 countries and Bayer's new R&D head Joerg Reinhardt told PharmaTimes World News that sales last year reached 50 million euros.
However he claims that in the countries where Xarelto is competing with Pradaxa on the VTE indication, Bayer's market share is double. He acknowledged that the market at present is a limited one and stressed that it is impossible to say whether that dominance will translate to the other indications.
Another key drug for Bayer is Nexavar (sorafenib), which is approved for kidney and liver cancer and had sales in 2010 of 705 million euros (+11.7%). Dr Dekkers told PharmaTimes World News that there are few growth opportunities in these indications left, except in China and Japan, and the compound is being studied in a number of other cancers, notably non-small cell lung, breast and thyroid.
Further down the pipeline, Dr Reinhardt noted the potential of VEGF Trap-Eye (aflibercept) which recently achieved positive results in two Phase III studies. as a treatment of central vein occlusion in the eye. On the basis of these data, marketing submissions are planned in Europe and the USA during the first half of 2011.
Dr Reinhardt told PharmaTimes World News that a review of the pipeline had resulted in around 10% of compounds being dropped, mainly projects in Phase I/II. He also noted that a new R&D structure has been put in place so that "instead of three-four meetings taking place, we have one" to speed up the process of decision-making.