Roche will not meet its previously disclosed goal of filing an investigational new drug application for an siRNA-based drug candidate in 2010, an official from partner Tekmira Pharmaceuticals disclosed last week.
As reported by Gene Silencing News in 2009, Roche had been expecting to file the IND on what would be its first RNAi drug sometime this year (GSN 10/1/2009).
Although the Swiss drugs and diagnostics firm has ongoing efforts to develop its own RNAi delivery technologies, Lou Renzetti, global head of RNA therapeutics for Roche, said at the time that its first candidate would use Tekmira's so-called stable nucleic acid lipid particle delivery approach.
However, "Roche has recently provided guidance to us that they are not going to meet their previous stated objective of filing an IND by year end," Tekmira President and CEO Mark Murray said last week during a conference call held to discuss this company's second-quarter financial results.
"It's difficult to know" the extent of the issue forcing the delay, he added in response to a question from a financial analyst. "Roche is a very large organization … and they just haven't told us clearly" what is going on.
"We will update the timeline as Roche provides updated guidance to us," he said.
A Roche spokesperson confirmed that the company has "informed Tekmira that the IND application for the lead product will not be filed before the end of 2010 as expected," but declined to provide additional details.