Bayer may have presented its best set of financials ever at its spring news conference in Leverkusen but a conservative forecast for 2008 involving a slowing-down in pharmaceutical sales is causing some concern.
As we reported yesterday, pharmaceutical revenues in 2007 shot up over 37% to 10.3 billion euros but Bayer chairman Werner Wenning told PharmaTimes World News that growth should be in the mid-single digits this year as the company faces up to generic competition for the hypertension treatment Adalat (nifedipine) and the antibiotic Cipro/Ciprobay (ciprofloxacin). Also of concern is a patent dispute with Barr Pharmaceuticals over the Yasmin (ethinyl estradiol/drospirenone) contraceptive franchise, sales of which passed the 1 billion euro mark. A decision on the dispute is expected shortly.
Another drug which brought in one billion euros was the multiple sclerosis drug Betaferon/Betaseron (interferon beta-1b) and Novartis will launch a generic version in the USA this year. However, Bayer will be doing the manufacturing of the drug for the Swiss-headquartered firm and also receive a double-digit royalty, Bayer Healthcare chairman Arthur Higgins told PharmaTimes World News, and the Novartis agreement should actually expand the market.
The run-up to Bayer’s results was dominated by the problems that the firm is having with currently-suspended Trasylol (aprotinin), which reduces bleeding during coronary artery bypass grafting. Two new analyses confirmed an increased incidence of death and kidney damage among patients given the drug and a US TV programme was broadcast and promoted by the claim that the lives of 22,000 patients could have been saved if the US Food and Drug Administration had pulled it two years ago.
Bayer voluntarily suspended sales in November 2007 after a Canadian study was stopped because of patient deaths and Mr Wenning limited himself to saying that the company is still waiting for the release of all the data from that trial before it decides what action to take. However the lawsuits are coming from the USA, around 50 or so.
Mr Higgins told PharmaTimes World News that he was not aware of any moves by Bayer to consolidate these suits and said that the firm is confident that it has acted correctly, noting that the FDA – twice – said last year that available data continue to support a favourable risk-benefit profile for Trasylol.
The company also commented on the disappointing data from last week which led to the firm calling a halt to a Phase III trial evaluating its promising oncology agent Nexavar (sorafenib) in patients with non-small cell lung cancer in combination with the chemotherapeutic agents carboplatin and paclitaxel. Mr Higgins said that the data was disappointing but such is the nature of research, particularly with lung cancer where there are hundreds of pathways that need to be explored. Combination therapy is the future, he added, and lung cancer studies will continue, as will research into Nexavar, which is approved for liver and kidney cancer, as a treatment fro breast cancer.
The next big thing to come out of Bayer’s pipeline is expected to be the antithrombotic Xarelto (rivaroxaban), which has been filed in Europe for the prevention of venous thromboembolism after major orthopaedic surgery of the lower limbs. Mr Higgins said the compound has the potential to “transform our company”, and concluded by saying that Bayer is in good shape for a firm of its size, in terms of healthcare, when analysts’ estimates put the value of the pipeline at around 9 billion euros. By Kevin Grogan in Leverkusen
