AstraZeneca looks to oncology pipeline after failure of Iressa
pharmafile | January 20, 2005 | News story | Sales and Marketing |
AstraZeneca has withdrawn its marketing application for its lung cancer drug Iressa in the European Union following the release of new long-term data which showed it to be no better than placebo in prolonging the lives of patients.
The news is a major blow for the company, which had hoped the drug could become a megabrand 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 Asian patients or those who have never smoked may show a better response, and have promised to look into the possibility of providing the drug for these groups.
Iressa's demise will be a major boost for Tarceva, another drug in the same EGFR (epidermal growth factor receptor) inhibitor class, marketed by Roche, Genentech and OSI. Tarceva has already been approved in the US and will shortly be launched 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 has come as 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.
Meanwhile, another oncology pipeline drug ZD6126, for a range of solid tumours, demonstrated toxic side-effects in phase II trials at the end of 2004, and has now been sent back to the laboratory for further testing.
Commenting on the setbacks, AZ chief executive Tom McKillop said: "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."
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.
Despite the bad news, McKillop said the company remained financially strong, and has reiterated its existing earnings guidance of $2.10 or slightly higher.
The company had hoped the drug would be a successor to its current rising star in breast cancer treatment Arimidex, which in turn built on the reputation of tamoxifen (branded as Nolvadex), currently the gold standard in breast cancer treatment.
Meanwhile, results are expected shortly from ZD6474, a drug designed to block the formation of blood vessels to supply tumours, thus holding back their growth. The drug has a similar mode of action to Iressa although it has the extra mechanism of action in blood vessels.
Dr George Blackledge, medical director of Astra-Zeneca's cancer research division said there was some "exciting" data on another drug, AZN2171, which is in phase I development and also works to inhibit the formation of blood vessels.
He said: "This is one that may move very quickly, assuming that the very encouraging data holds up.Two further candidates with potential, AZN6244 and AZN3409 are expected to start phase II trials in 2005."
