Trial data sounds death knell for Iressa
pharmafile | December 21, 2004 | News story | Sales and Marketing |
AstraZeneca has effectively given up on its cancer drug Iressa, admitting that data from a new large scale trial shows it to be no better than placebo in prolonging the lives of lung cancer patients.
The news is a major blow for the company, which had hoped the drug could become one of its megabrands in oncology, with peak sales forecast at over $1 billion.
Iressa (gefitinib) has been used in over 200,000 patients since its first launch in Japan in 2002 and is licensed in more than 30 other countries including the US, but AstraZeneca says it will now stop marketing the drug and will discuss its withdrawal with regulators.
The new large-scale trial of nearly 1,700 patients was looking for increased survival rates in patients, but despite statistically significant improvement in tumour shrinkage, this did not translate into a significant survival benefit.
Patients on the trial all had non-small cell lung cancer (NSCLC) and were either intolerant of or no longer responding to their last chemotherapy treatments.
Lead researchers say Japanese patients or those who have never smoked may show a better response, but the company now looks highly unlikely to pursue a marketing application in Europe.
Tarceva, another drug in the same class (epidermal growth factor receptor inhibitors) marketed by Roche, Genentech and OSI has already been approved in the US and will shortly be launched in Europe, and will benefit from Iressa's failure.
AstraZeneca chief executive Sir Tom McKillop said: "I think with the Tarceva product being potentially available, then it is unlikely that Iressa would be approved in Europe."
The FDA says it will evaluate the recent study results and may order Iressa's withdrawal from the market or other regulatory actions as appropriate.
Iressa only received approval from the FDA at the start of 2004 but the US already accounts for half of its sales, which stood at $300 million for the first nine months of the year.
The news is yet another blow to AstraZeneca's share price and its long-term revenue outlook after several major setbacks in 2004, including the FDA's rejection of Exanta, continued safety doubts about Crestor and a delay in the development of diabetes drug Galida.
In response to Exanta's rejection, the company has announced that current head of global marketing, product portfolio and licensing John Patterson will take on a special new boardroom role to ensure the costly regulatory setback is never repeated.
McKillop concluded: "We have embarked on some major breakthrough clinical research with drugs like Exanta and Iressa.
"This is difficult; fundamentally breaking new ground. But when we look back, we realise that we could, indeed, have managed some of these risks better. So we are taking on board that learning and we are determined to implement more effective mechanisms to manage risk and to deliver these programmes effectively."
Despite the bad news, McKillop said the company remained financially strong, and has reiterated its existing earnings guidance of $2.10 or slightly higher.
