Bayer and partner Genzyme Corp have been boosted by the news that European regulators have granted the German firm expanded marketing authorisation for its oncology drug MabCampath, sold in the USA as Campath.

The European Commission has given the green light for MabCampath (alemtuzumab) to be used as a treatment for B-cell chronic lymphocytic leukaemia in patients for whom fludarabine combination chemotherapy is not appropriate. The drug “works in an entirely different way than chemotherapy”, Bayer noted, and is the only monoclonal antibody approved in Europe for the treatment of B-CLL. It is already approved for the treatment of B-CLL in patients who have been previously treated with alkylating agents and have failed fludarabine therapy.

Approval for the expanded label was based on data from the CAM307 Phase III trial comparing MabCampath with chlorambucil in previously untreated patients with the disease. The study demonstrated that the Bayer/Genzyme drug showed superior progression-free survival and reduced the risk of disease progression or death by 42%. Last September, the US Food and Drug Administration gave the firms the go-ahead to market Campath as a first-line treatment for B-CLL.

Broker still bullish on Bayer
Meantime, the Leverkusen-headquartered firm may have been replaced (by Belgium’s UCB) as Dresdner Kleinwort’s key pick outside the ‘big five’ pharma stocks in Europe, but the analysts say in a report that they “remain very bullish on Bayer”. It had a “great run in 2007,” the broker says and despite a 54% share price climb for the year, the stock remains cheap, “particularly when compared to Novo Nordisk with which Bayer shares safe-haven characteristics”.

Like Novo, Bayer has a “very solid patent profile, lucrative pipeline and solid management,” the Dresdner Kleinwort report adds, and growth should accelerate by the time its peers suffer patent expiries. Also, its non-pharma businesses will “dilute patent risks further without increasing capital intensivity”, the broker concludes.