First European approvals for Amgen's Neupogen

1991/03/25

US BIOTECH company Amgen has won the first European approvals to market its cancer treatment drug Neupogen, weeks after winning approval in the US from the Food and Drug Administration. Last week the Swedish and UK health authorities gave it the go-ahead.

The company and its European marketing partner Hoffmann-La Roche are now awaiting approval from a number of other European countries.

Neupogen contains human granulo-cyte-colony stimulating factor (G-CSF) which has been shown in clinical trials to stimulate production of neutrophils with minimal side-effects. It is reported to reduce the risk of fever and low white blood cell count that commonly occur as a result of cancer chemotherapy, necessitating dose reduction and delays.

'This therapy is a significant breakthrough for cancer patients who until now have had their treatments delayed or reduced because of the risk of potentially fatal infections,' says Dr Armin Kessler, chief operating officer of Hoffmann-La Roche in Basel. Roche is to market the drug in Sweden and the UK, and to collaborate with Amgen in its development in the EC.

First cloned, expressed and produced in 1985 by Amgen, Neupogen is the second haematopoietic growth factor to be commercialised by the company. Its first, Epogen, is based on recombinant human erythropoietin and regulates the body's production of red blood cells. Launched in the US in 1989, Epogen is marketed under licence in Europe by Cilag. Sales of Epogen in 1990 are estimated at $277m, making it the world's second best selling biotech drug after Eli Lilly's Humulin.

Neupogen potentially has markets up to twice as large as those for Epogen. While these are expected to be penetrated more slowly, and could generate competition in the form of granulocyte macrophage colony stimulating factor (GM-CSF), in the US notably from Immunex and a Schering-Plough/Sandoz venture, the gaining of approvals in the US and now Sweden and the UK is seen by observers as a major boost to Amgen's ambitions to become a major pharmaceutical force worldwide.