October 30, 2008 / 2:34 PM / 11 years ago

Astra drug Crestor finally gets German green light

LONDON, Oct 30 (Reuters) - It has been a long time coming but AstraZeneca’s (AZN.L) blockbuster cholesterol drug Crestor has finally won approval in Germany — more than five years after its first launch in some other European markets. The Anglo-Swedish company said on Thursday it had secured new marketing authorisation licences this month in Germany, which is Europe’s biggest market, as well as Spain, Poland, Norway and Malta.

However, the Anglo-Swedish drugmaker still has a fight on its hands to negotiate an acceptable price for the product in Germany, which has a reputation for trying to keep a tight lid on medicine costs.

“The next step, clearly, is to work through access and pricing in those markets, including Germany,” Chief Financial Officer Simon Lowth told analysts in a results conference call.

“It’s too early to tell you how that will unfold. It’s clearly a strong product and we look forward to seeing how we can best bring it into the German market.”

Germany is viewed by drug companies as a particularly difficult market due to government actions designed to drive down drug prices. These include a so-called jumbo reference system that lumps together drugs in the same class in terms of pricing.

Most European countries approved Crestor in 2003. But Germany at the time wanted stricter warnings on possible side effects, following concerns about the entire statin drug class triggered by the withdrawal of Bayer’s BAYG.DE Baycol in 2001.

Worries about safety issues dogged Crestor’s early commercial life. But those concerns have since waned and the product has gone on to establish itself as an effective and popular treatment, with a better record of reducing levels of bad cholesterol than many rivals.

Worldwide sales of the medicine reached $2.61 billion in the first nine months of this year, up 24 percent on the year-ago level in constant currency terms.

The latest marketing authorisations mean Crestor is now approved for use in every country in the European Union. (Reporting by Ben Hirschler; Editing by Quentin Bryar)

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