Independent Advisory Panel Recommends
‘Accelerated’ Approval
San Diego’s biotechnology firm Idec Pharmaceuticals Corp. cleared a major hurdle when the Food and Drug Administration’s advisory panel recommended approval for its powerful radioactive non-Hodgkin’s lymphoma drug, Zevalin.
Idec said Sept. 11 the FDA’s oncologic drugs advisory committee voted 13-2 to recommend Zevalin for treating non-Hodgkin’s lymphoma patients.
This makes final approval near certain.
In an unexpected move, the independent panel also recommended “accelerated” approval for the drug, which means Idec could sell the drug if certain provisions that have yet to be determined are met.
Phillip Schneider, Idec’s CFO, remained cautious in his interpretation.
“In a panel meeting one individual said we may just need to follow existing data for one year (that means patients who have participated in a Zevalin trial),” Schneider said. Idec won’t know whether it will need to run more studies until it meets with FDA officials, he added.
Brad Stone, an FDA spokesman, declined to comment on a timeline for the meeting.
“It depends on the drug and the amount of data that is before the FDA (and) what we privately determine is the safety and efficacy of the product,” Stone said.
If approved, Zevalin would be the first cancer-fighting antibody with an attached radioactive isotope on the market.
The unique approach uses antibodies that occur naturally in the bloodstream to deliver a radioactive particle to a tumor without harming the healthy cells.
Idec is already marketing a successful non-Hodgkin’s lymphoma drug named Rituxan.
The attached isotope makes Zevalin more toxic than Rituxan, and thus, would be used as a last resort after all other treatments failed.
Consequently, the market size for Zevalin is significantly smaller than for Rituxan.
Schneider estimated between 35,000 and 40,000 patients may receive Zevalin infusions vs. the hundreds of thousands of patients receiving Rituxan today.
Zevalin’s price has yet to be determined. Idec is seeking coverage from health plans and government health insurance programs.
Compared to Rituxan, whose proceeds are shared with Genentech, Idec retained rights for Zevalin in the United States.
A patent dispute, however, is pending.
On Sept. 11, Idec filed two separate lawsuits seeking a declaratory judgment that it didn’t infringe on patents held by Glaxo SmithKline and Corixa Corp., Coulter Pharmaceuticals, Inc., which developed a similar treatment to Zevalin.
Kenneth Woolcott, Idec’s vice president general counsel and licensing executive, said Idec filed the lawsuits after it learned Corixa in Seattle planned to assert patents once Idec began to commercialize Zevalin.
On Sept. 12, Corixa and GlaxoSmithKline in Philadelphia said in a joint statement they filed a complaint in Delaware District Court for patent infringement against Idec.
In the complaint, it is stated the firms “seek available remedies under the patent law, including monetary damages and permanent injunctive relief.”
John McCamant, editor of the Berkeley-based Medical Technology Stock Letter, said Glaxo and Corixa hope to cash in after Zevalin hits the market.
“Idec is a very, very rich company,” McCamant said.
He pointed to Idec’s market capitalization of $8.5 billion versus Corixa, which has a market cap of $440 million, despite its “promising pipeline of drugs.”
“Idec is overvalued relative to Corixa,” McCamant said bluntly.
He added, “Idec will need to sell an awful lot of drugs to meet the expectations built into the market cap.”
Idec spokesman Vince Reardon said the Sept. 11 endorsement by the FDA’s advisory committee was bittersweet for Idec.
“There was no party,” he said.
