schering buoyed by fda priority cancer drug review
UPDATE 3-Schering buoyed by FDA priority cancer drug review September 9, 2004 7:43am ET (Reuters)
(Adds dermatology unit named Intendis, details)
By Mark Thompson
FRANKFURT, Sept 9 (Reuters) - German drugmaker Schering AG was boosted on Thursday as the U.S. Food and Drug Administration granted its Bonefos treatment "priority review" for the prevention of bone tumours in breast cancer patients.
The status is usually granted to drugs that could represent significant therapeutic improvement over existing treatments and address unmet medical needs. It provides for a six-month review from the date of filing.
Industry analysts said the move was a positive surprise for the Berlin-based company and could breathe new life into sales of the product, which brought in just 49 million euros ($60 million) last year.
Equinet analyst Martin Possienke said the new application might generate extra sales of about 150 million euros.
Schering said its U.S. affiliate Berlex Laboratories was seeking approval for Bonefos as an oral treatment for reducing bone metastases in breast cancer patients.
"This designation recognises the significant unmet medical need facing women currently living with breast cancer," Schering's vice president clinical development oncology, Reinhard von Roemeling, said in a statement.
Bonefos belongs to a class of medicines -- known as bisphosphonates -- with considerable commercial potential.
Novartis AG's rival product Zometa, for example, sold nearly $900 million in 2003, of which two-thirds was in the United States.
But a second London-based analyst said Schering appeared to be ahead of Novartis in developing its drug for the prevention of bone metastases. Metastases occur when cancer spreads from one part of the body to another.
Bonefos is already approved in 79 countries as a treatment for bone breakdown and abnormally high blood calcium levels in cancer patients.
Schering shares stood out as one of only two gainers on the blue-chip DAX index , adding 1.9 percent to 48.05 euros by 1038 GMT while the index fell 1 percent.
About one in eight women in the United States will develop breast cancer, according to a National Cancer Institute report.
Schering is the world's biggest producer of hormone drugs by volume. It launched hormone replacement therapy (HRT) pill Angeliq in top European market Germany and some Nordic countries earlier this month.
Oncology is Schering's third-biggest pharmaceutical business.
Separately, Schering said it had given the named Intendis to a new company formed by spinning off its dermatology unit. The new firm will start operations as a separate legal entity from January 1 of next year and have a workforce of 600 globally.
Schering said in June that it was separating the low margin unit and could seek partners for it as part of a programme to improve profitability.
A Schering statement quoted Wolfgang Kehr, designated head of the new company, as saying that its aim was to become one of the ten largest companies worldwide in dermatology by 2010.
The business had sales of 200 million euros in 2003 out of Schering's total sales of 4.83 billion. (Additional reporting by Ben Hirschler in London and Sitaraman Shankar in Frankfurt
