Analysts predict a second-quarter launch of IDEC Pharmaceuticals Corp.’s investigational agent for non-Hodgkin’s lymphoma.
In accordance with the six-month deadline imposed by the Prescription Drug User Fee Act, the FDA notified IDEC Wednesday that its July 8 application for Zevalin (ibritumomab tiuxetan) is approvable pending resolution of certain manufacturing compliance issues at the company’s fill/finish provider, Catalytica Pharmaceuticals Inc., of Greenville, N.C.
“While I cannot speak for the FDA, my own interaction with them over the past week suggests that there is strong support at the agency for Zevalin and a desire on their part to make it available on a broader basis through approval and commercialization,” William Rastetter, IDEC’s chairman, president and CEO, said in a conference call with investors and analysts Wednesday.
Following recommended approval by the FDA’s Oncologic Drugs Advisory Committee Sept. 11, analysts were looking toward a first-quarter launch, with first-year sales ranging from $70 million to more than $100 million. However, the snag at Catalytica delays the launch and obviously cuts projected sales by millions of dollars.
“This is an issue at the fill/finish contract manufacturer for IDEC,” Peter Ginsberg, senior biotechnology analyst at U.S. Bancorp Piper Jaffray in Minneapolis, told BioWorld Today. “I would consider this to be a minor part of the manufacturing process; the FDA has OK’d other parts of the manufacturing. I do not think this is going to be a significant delay, but it is going to be a few months.”
Ginsberg said at its peak in the U.S., Zevalin sales likely could top $200 million annually. He expects sales to reach $40 million in 2002 and $112 million in 2003.
A research note released by Patrick Mooney, a vice president with Thomas Weisel Partners LLC in New York, estimated 2002 sales at $62.3 million, and 2003 sales at $111.4 million.
Rastetter deferred most questions about Catalytica and Zevalin’s launch to IDEC’s upcoming year-end conference call Jan. 29.
Details about the compliance issues at Catalytica are sketchy because the FDA letter does not list specific problems. The next step, Rastetter said, is to meet with the FDA and Catalytica to negotiate a solution. “If we all agree that re-inspection [of the Catalytica facility] is the best course to take, the FDA has expressed its willingness to move quickly with re-inspection,” Rastetter said.
The FDA conducted a pre-approval inspection of Catalytica in August, but since then, Rastetter said substantial compliance and validation upgrades triggered by a third-party compliance expert have taken place. “In September, October, November and December, Catalytica saw a tremendous amount of work on things like environmental monitoring, training procedures, fill-line revalidations and so forth. So in essence, the organization that exists today at Catalytica is a different one, even in terms of some of the upper management that existed in August when it was inspected.”
Rastetter said he was aware that the FDA had problems late last year at the Catalytica plant in reference to Indianapolis-based Eli Lilly & Co.’s sepsis product, Xigris. (Xigris received FDA approval Nov. 21.)
On the bright side, Rastetter said, the FDA’s complete review letter says filing for Zevalin is complete and acceptable. “That’s important because it means a tremendous amount of work leading up to approval has already been accomplished. For example, one critical hurdle labeling discussions with the agency has been completed successfully. Therefore, we have FDA authorization to begin production of package inserts, labels and packaging,” he said.
He wouldn’t comment on details of the label except to say, “It’s bigger than a breadbox and we are very happy with the labeling discussions. I hope that’s an indication of where we are.”
In a 13-to-2 vote, ODAC recommended 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. And in a unanimous vote, the panel recommended approval of Zevalin for Rituxan-refractory patients. (See BioWorld Today, Sept. 13, 2001.)
Even with this delay, IDEC likely will launch Zevalin before Seattle-based Corixa Corp. wins clearance for its lead product candidate, Bexxar, a monoclonal antibody conjugated to the radioisotope idoine-131. Bexxar is being developed to treat relapsed or refractory, low-grade follicular, CD-20-positive B-cell non-Hodgkin’s lymphoma.
Corixa filed its BLA in September and Mooney said the company is likely to present its application at the February meeting of ODAC.
In a deal worth about $47 million, IDEC partnered Zevalin with Schering AG, of Berlin, outside the U.S. IDEC retains the rights in the U.S. (See BioWorld Today, May 11, 2001.)
IDEC’s stock (NASDAQ:IDPH) closed Wednesday at $63.21, down $1.05.