Germany’s Bayer has presented a strong set of financials for its healthcare division for the third quarter at its autumn press conference in Leverkusen which prove that the acquisition of Schering AG last year has provided the firm with some very big earners.

As we reported yesterday, group sales were up 4.5% to 7.79 billion euros, with healthcare turnover climbing5.7% to 3.68 billiobn euros. Pharmaceutical sales were up 5.2% to 2.57 billion, driven by Schering’s Betaferon/Betaseron (interferon beta 1b) for multiple sclerosis (262 million euros; +6.5%) and the Yasmin (ethinyl estradiol/drospirenone) contraceptive franchise (278 million euros; +35.0%).

However one disappointing factor during the quarter was the news that Betaferon does not work any better at a higher dose, ie 500mcg compared with 250mcg, which led to the firm taking a 152 million euro impairment charge. While the results from the BEYOND study were disappointing, Bayer Healthcare chairman Arthur Higgins looked on the positive side and told PharmaTimes World News that at least the data confirmed that Betaferon 250mg is highly effective and very well tolerated compared with Teva’s rival drug Copaxone (glatiramer acetate).

Back to the financials and as for Bayer’s own products, the haemophilia agent Kogenate (recombinant antihaemophilic factor), climbed 7% to 213 million euros, while the antibiotic Avelox (moxifloxacin) had sales of 99 million euros, up 25.3%.
The erectile dysfunction drug Levitra (vardenafil) rose 10.4% to 85 million euros, though sales of the hypertension treatment Adalat (nifedipine) slipped 1.9% to 152 million euros, while the antibiotic Cipro/Ciprobay (ciprofloxacin) fell 17.9% to 96 million euros as a result of generic competition.

However most excitement was reserved once again for the performance of Nexavar (sorafenib), which has just been approved for a new indication, liver cancer. The drug brought in 76 million euros as a treatment for advanced kidney cancer, representing a 100% rise. The drug is also being looked at in clinical trials for malignant melanoma, breast and lung cancer and Mr Higgins said that data from a Phase III lung cancer trial should be available by the end of next year.

Still keeping the faith with Trasylol
Inevitably much of the conference was taken up with questions about Trasylol (aprotinin), used to reduce blood loss during heart surgery and temporarily suspended. Bayer chairman Werner Wenning told PharmaTimes World News that the firm had little to add to the announcement on Monday that health authorities in the USA, Canada and Germany had asked that marketing be suspended until final data from the BART trial - an independent randomised, controlled study in Canada assessing the drug in high-risk cardiac surgery patients – become available for assessment.

“I can’t say any more until the complete data is seen,” he said, noting that this will take up to six to eight weeks. Mr Higgins was more forthcoming, however, and said that the US Food and Drug Administration has been “very, very cooperative” in working with the company on Trasylol and despite the suspension, the agency has requested that treatment continue to be used in certain situations after discussing the issue with physicians.

Mr Higgins told PharmaTimes World News that Bayer is still committed to the product. The FDA has twice recently said that available data continue to support a favourable risk-benefit profile for Trasylol when used according to labelling, though he acknowledged that the BART study may possibly change that state of affairs. Whatever happens, Mr Higgins and Mr Wenning both noted that the financial contribution of Trasylol is no longer material, given that sales for the nine-month period were 93 million euros.

By Kevin Grogan in Leverkusen