Biotech: Agency Also Wants to Inspect Its
Manufacturing Plants
San Diego-based Idec Pharmaceuticals Corp. said it plans to submit information requested by the U.S. Food and Drug Administration on its non-Hodgkin’s lymphoma treatment Zevalin by mid-July.
On May 10, Idec received a letter from the FDA asking the biotech firm to submit more data on clinical, chemistry and manufacturing and control issues.
Idec’s Chief Operating Officer William Rohn said in a May 10 conference call that the FDA does not require Idec to conduct additional trials.
However, the FDA requires Idec to add imaging to its therapy regimen as a safety measure.
Rohn admitted the requirement will make patients’ treatments more complex, as patients will need to see two specialists , an oncologist and a radiologist , and raise treatment costs by more than $500.
Consequently, Idec will need to introduce two separate kits , an imaging kit and a therapeutic kit , to the marketplace, Rohn said.
“We are working with contractors to schedule kits and put them together,” said an Idec official. New labeling is being addressed with the FDA, he said.
Additionally, the agency wants to inspect the manufacturing plants of Idec’s radiolabel compound suppliers, Rohn said, adding the company is working with government agents to schedule an inspection date.
He said the company has already begun to address key issues with FDA agents.
Rohn described Idec’s interactions with federal agents as “positive, productive and open.”
Idec hopes to schedule an oncology drug advisory committee meeting to “have a chance to portray the full profile of the drug,” he said.
Rohn did not want to speculate when the FDA may get back to Idec after it submits the requested data.
He said Idec officials “hope the FDA will not see long-term safety concerns” with the experimental therapy.
But Jim McCamant, editor of the Berkeley-based Medical Technology Stock Letter, remained skeptical about a near approval.
“We don’t have super-high expectations,” McCamant said.
He said that goes for Idec’s drug Zevalin and a similar treatment developed by Idec’s rival Corixa Corp. in Seattle and San Francisco.
McCamant foresees multiple barriers.
These include oncologists and radiologists having to collaborate. He said this is easier done in clinical trials than in a hospital setting.
Doctors would need to learn about the first-ever “immunotherapy” to hit the marketplace in the United States.
Then there is the question of reimbursement for the costly drug.
He said, however, Idec may have an edge on its rival, because Zevalin is the second-generation drug of the highly successful non-Hodgkin’s lymphoma drug, Rituxan.
South San Francisco-based Coulter Pharmaceutical, Inc. (now a unit of Corixa Corp.) developed the rival drug Bexxar, which is also being reviewed by the FDA.
Corixa sought FDA approval for Bexxar on Sept. 15. Corixa was asked to modify its application. The company did so and was asked again March 19 to “outline additional clinical and manufacturing information” to prove Bexxar is safe and effective.
Corixa spokesman Jim DeNike said the company will submit the requested data sometime this summer.
“At that time we expect the FDA to commence a second six-month review,” DeNike said.
DeNike said Corixa isn’t too worried about Idec’s drug Zevalin beating it to the marketplace. “We will continue to move forward,” he said.
To date, there have been no head-to-head studies conducted comparing Bexxar to Zevalin.
