MADRID, Sept 27 (Reuters) - AstraZeneca said on Saturday it expected to file a new lung cancer pill for U.S. regulatory approval in the second half of 2015, potentially disappointing some investors who had hoped the drug might be ready faster.
Analysts at Citi said in a research note this week they believed AZD9291 could be submitted as early as the first quarter of 2015, putting AstraZeneca ahead in a race with Clovis Oncology, which is developing a similar medicine.
Drugs from both companies target a genetic mutation that helps tumours evade current lung cancer pills, including AstraZeneca’s established product Iressa.
In an update issued at the European Society of Medical Oncology annual congress in Madrid, AstraZeneca said it had made significant progress with its development programme for AZD9291 but did not change the anticipated timetable for filing.
A company spokeswoman said this did not mean there was no chance of an earlier filing. “If we can file earlier we will, but it will definitely be by the second half of 2015 at the latest,” she said.
AstraZeneca believes AZD9291 could sell as much as $3 billion a year. (Reporting by Ben Hirschler; Editing by David Holmes)