Germany delay undermines Crestor confidence
pharmafile | October 31, 2003 | News story | |Â Â Â
AstraZeneca's cholesterol treatment Crestor has been dealt a serious blow following Germanys withdrawal from a pan-European approval process.
Germany, the EU's biggest pharmaceutical market, has been joined by Spain and Norway in withdrawing from the mutual recognition procedure and in doing so has undermined confidence in the long-awaited drug before its launch.
Launches in these markets are expected to be delayed by at least a few months, although the procedure has been agreed in 13 other countries where launches are expected to go ahead without any hold-ups.
Although no reason has been given for the decision, analysts are convinced concerns about the drugs safety are the most likely explanation.
Nick Turner of Jeffries Europe says that Crestor's superior efficacy will not make European doctors switch from existing statins such as Merck Sharp and Dohme's Zocor and Pfizer's Lipitor.
"Given the evidence for the long-term safety of Lipitor and Zocor and the safety concerns on superstatins that were raised by the Baycol withdrawal, we believe that an 8-9% increase in the number of patients achieving treatment goals on the starting dose of Crestor is unlikely to sway medical opinion away from the established drugs," he said.
AstraZeneca abandoned the drug's 80mg dose last year after it was linked to serious side-effects but insists this has no bearing on the lower dose range. Despite this, the company has been forced to submit new data to the FDA to kick-start Crestors approval in the US, now expected towards the end of 2003.
Turner said this and the delays in Europe would "conspire to highlight safety issues with prescribers". Bayers statin Lipobay/Baycol was withdrawn in 2001 after it was linked to fatal side-effects in some patients.
The product has already been launched in two markets, Canada, where it was launched at a lower price to Lipitor, and the Netherlands, where it matches the cost of Pfizer's product.
These pricing strategies are almost certain to be matched in all other markets in order for the company to seize as much market share, and as early as possible. AstraZeneca is aiming to take 20% of the global statin market, which is currently worth $19 billion a year and growing at 15% annually.
