Novartis will seek regulatory clearance for kidney cancer drug Everolimus in H2 of 2008 after it cleared late-stage testing earlier than expected, the Swiss drugmaker said.Everolimus, which analysts say could generate around €300 million a year in revenue by 2012, would compete in the crowded market for kidney cancer treatments that include Bayer's Nexavar, Pfizer's Sutent and Wyeth's Torisel.
“This is positive news for Novartis even if Everolimus would be competing in a crowded kidney cancer market,” said BNP Paribas analysts in a note.
Late-stage, or Phase III trials of the drug were halted early after interim results showed significantly better survival in patients with advanced kidney cancer who received Everolimus compared to placebos, Novartis said.
Worldwide regulatory filings for this indication beginning with US and EU authorities would be made in the second half of 2008, Novartis said. Regulators take roughly one year to render decisions, required before new treatments can come to market. (Reuters)