Unspecified compliance issues at a North Carolina manufacturing facility likely will cause IDEC Pharmaceuticals Corp. to delay the launch of Zevalin, a radioimmunotherapy for non-Hodgkin’s lymphoma.
Although IDEC on Tuesday was expecting the FDA to approve Zevalin, the company released a statement saying it had been informed by phone that marketing approval would be “pending resolution of certain manufacturing compliance issues at the company’s fill/finish provider.” The provider is Catalytica Pharmaceuticals Inc., of Greenville, N.C.
IDEC’s stock (NASDAQ:IDPH) closed Tuesday at $64.26, up $1.95.
As per the Prescription Drug User Fee Act, the FDA was required to respond to IDEC’s Zevalin application by Tuesday in order to meet the six-month deadline.
IDEC said the FDA would not require additional clinical data or trials.
“We’ve been told there are certain manufacturing compliance issues, but we don’t know the nature of the exact problem,” said Vince Reardon, director of corporate communications for San Diego-based IDEC. “We do know that the problem is not specifically related to the product.”
And since IDEC doesn’t know what the problem is, the company can’t say how long it will take to correct it, Reardon told BioWorld Today.
According to research notes released by Leah Rush Cann, senior vice president at Wachovia Corp. in New York, the FDA previously had manufacturing concerns with the Catalytica plant in reference to Indianapolis-based Eli Lilly & Co.’s sepsis product, Xigris, which received FDA approval Nov. 21.
Cann’s note reported that IDEC Chief Operating Officer Bill Rohn said the issues with Catalytica could be resolved through a re-inspection of the facility, a third-party inspection or a commitment from Catalytica to remedy the situation.
Several months ago, Lehman Brothers of New York estimated that Zevalin would be launched in early 2002 and generate about $70 million in its first year of U.S. sales.
Cann anticipates a March 1 launch with 2002 sales reaching $133 million in the U.S., a higher figure than many other analysts project.
Back in September, the FDA’s Oncologic Drugs Advisory Committee recommended approval of Zevalin for two different indications. (See BioWorld Today, Sept. 13, 2001.)
In a 13-to-2 vote, the panel recommended accelerated approval of Zevalin in patients who have not failed Rituxan, a treatment for chemotherapy-refractory, low-grade, non-follicular NHL that is co-promoted in the U.S. by IDEC and Genentech Inc., of South San Francisco. In a second vote, which was unanimous, the panel recommended approval of Zevalin for Rituxan-refractory patients.
Zevalin is used to shrink tumors but may have some side effects, including reduction in blood cell counts.
Although IDEC retains all rights to Zevalin in the U.S., the company partnered the drug with Schering AG, of Berlin, outside the U.S. in a deal worth about $47 million. (See BioWorld Today, May 11, 2001.)
IDEC will host a conference call this morning to discuss the FDA letter.