AstraZeneca Plc might not launch its biggest new drug hope, Crestor, in Germany because of a row over the product's label and potential pricing problems, the company's chief executive said on Thursday.
The Anglo-Swedish group is the latest drug-maker to slam the hostile environment in Germany, Europe's biggest market, where government healthcare reforms are making life increasingly difficult for the pharmaceutical industry.
"Germany is becoming a really sad situation in Europe in terms of pharmaceuticals," Tom McKillop told Reuters in an interview.
McKillop said he still hoped cholesterol fighter Crestor would go on sale in Germany but he was not prepared to compromise on the product's label, setting out its recommended use, or its price.
Most European countries approved Crestor early last year. But Germany wanted stricter warnings on possible side effects, following concerns about the entire drug class triggered by the withdrawal of Bayer AG's Baycol in 2001.
Baycol was linked to more than 100 deaths but AstraZeneca says there is no evidence that Crestor has similar problems and its drug is just as safe as established rivals, such as Pfizer Inc's Lipitor.
"There is no doubt that of the all the regulatory agencies around the world, the Germans were most scarred by the Baycol experience and have been very, very conservative in their position," McKillop said.
"We were not prepared to accept what the Germans were asking for first time round and we are discussing and showing them newer data. It will be up to them to decide at what point they want to accept our European label."
McKillop said Germany was, in any case, an increasingly difficult market following government actions designed to drive down drug prices.
These include a system known as "jumbo reference pricing" which would lump all cholesterol-lowering statin drugs together in terms of pricing.
"If the price we were receive in Germany were a threat to our European pricing, we wouldn't launch anyway," he said.
"This is increasingly an issue I think drug companies are going to be faced with. If you have one country that really seriously erodes a company's pricing structure, then you are going to see companies saying: 'Sorry, we can't launch'."
AstraZeneca shares were down 1.6 percent at 2,667 pence at 1520 GMT, under-performing the DJ Stoxx European drugs index, which was 0.4 percent lower.
A number of drug firms have railed against Germany's healthcare system recently, including Pfizer, which has said it may move research to Britain.
In the United States, McKillop said Crestor sales had been checked temporarily by safety concerns following a call in March by the Public Citizen consumer group for the drug to be banned.