There were big smiles all round in Leverkusen yesterday as Germany’s Bayer presented a strong set of financials for its healthcare division which suggests that the firm’s acquisition of Schering AG is going to prove to be a very sound bit of business.
As we reported yesterday, pharmaceutical sales in particular caught the eye, leaping almost 84% to 7.48 billion euros in 2006, driven by Schering’s Betaferon/Betaseron (interferon beta 1b) for multiple sclerosis (991 million euros; +14.3%) and the Yasmin (ethinyl estradiol/drospirenone) contraceptive franchise (794 million euros; +35.5%). However Bayer’s own products faired pretty well, with the haemophilia agent Kogenate (recombinant antihaemophilic factor), climbing 18.7% to 787 million euros, while the antibiotic Avelox (moxifloxacin) had sales of 396 million euros, up 8.8%.
The erectile dysfunction drug Levitra (vardenafil) increased 20.8% to 314 million euros, while the hypertension treatment Adalat (nifedipine) put in a striking performance once again. Sales were flat at 657 million euros but that is an extremely impressive amount given that patent protection on the active ingredient was lost some 21 years ago, suggesting that Bayer is doing something right when it comes to life cycle management.
However most excitement was reserved for the performance of Nexavar (sorafenib), which is currently approved as a treatment for advanced kidney cancer, and brought in 130 million euros for its first year on the market. Werner Wenning, chairman of the board at Bayer, said that the figure was well beyond expectations and the drug is also being looked at in clinical trials for melanoma and advanced liver cancer. If approved for these indications, Nexavar sales could easily reach 500 million euros, Mr Wenning said, and this could rise to 1 billion euros if the drug gets the go-ahead for other cancers, including breast and lung cancer.
Bayer and partner Onyx were rocked by clinical data from a late-stage trial last December which revealed that Nexavar was not effective in treating patients with advanced melanoma but a Phase III study for liver cancer was much more positive and Arthur Higgins, chairman of Bayer HealthCare, told PharmaTimes World News that a filing with the US Food and Drug Administration is imminent. A dialogue is taking place with the agency at the moment, he noted.
There was one blot on the sales sheet, however, with the performance of Trasylol (aprotinin), which is used to reduce blood loss during heart surgery. Revenues fell 33.5% to 153 million euros, hurt by the FDA’s insistence on a new label which highlights the possible risk of kidney damage associated with taking the drug.
This came after Bayer had been late in presenting new data on Trasylol to the agency, which led to the company setting up an external investigation by a US lawyer. However, Mr Higgins told PharmaTimes World News that the inquiry had to be put on hold as the lawyer was poached by the White House to work as a counsel for President Bush but the investigation has now resumed. At the beginning of this year, further negative data on Trasylol was published in the Journal of American Medical Association, but Bayer rejected it as unreliable and still maintains the drug “is a safe and effective medicine when used correctly.” By Kevin Grogan in Leverkusen
