Washington Editor

Cell Therapeutics Inc.'s deal to acquire Zevalin (ibritumomab tiuxetan), the first radioimmunotherapy approved for marketing in the U.S. for non-Hodgkin's lymphoma (NHL) from Cambridge, Mass.-based Biogen Idec., sets the stage for the Seattle-based firm's reentry into the anticancer drug market.

CTI has agreed to pay Biogen $10 million in cash upfront, up to $20 million in milestone payments and royalties on sales. The milestone payments will be paid when the product receives approval for a first-line indication for NHL.

Under the agreement, which is expected to close in 30 days, CTI will take over U.S. marketing, sales, and development of Zevalin. The product will continue to be sold outside the U.S. by Bayer Schering under an agreement with Biogen Idec.

Biogen reported 2006 sales of the drug at $16.4 million.

CTI Chief Executive Officer James A. Bianco told BioWorld Today that the acquisition of Zevalin is part of the firm's strategy to jump into the lymphoma drug market.

The company saw modest success with its leukemia drug Trisenox (arsenic trioxide), which received approval in 2000, Bianco said. He noted that sales of that drug, the firm's first commercial product, peaked at about $22 million. CTI sold Trisenox to Cephalon in 2005.

Zevalin, Bianco said, has an untapped potential in the marketplace because of the changing environment in how the drug can be administered to patients.

When it was first approved in 2002, the drug was administered in the hospital setting only, primarily in large academic centers. However, because more oncologist group practices have invested in PET scan technology, they have nuclear medicine specialists or radiation oncologists onsite, which make those practices more ideally suited to administer Zevalin.

CTI will be working to get the product into all large oncology practice groups that have nuclear medicine specialists or radiation oncologists onsite.

CTI also plans to seek approval of the drug as a first-line consolidation therapy for patients who do not achieve complete remission on standard chemotherapy, which would move Zevalin therapy to earlier in the course of the disease.

Currently it is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL, including patients with Rituximab-refractory NHL.

Up to 55 percent of patients receiving standard chemotherapy for NHL do not achieve complete remission, Bianco noted.

Because of Zevalin's particular type of radioisotope, it also is safer to handle and administer than GlaxoSmithKline's Bexxar (tositumomab), Bianco claimed.

He said the firm expects Zevalin sales to peak at $250 million.

Zevalin, he said, also complements CTI's development of pixantrone, an agent being investigated as a treatment for various hematological malignancies, solid tumors and immunological disorders. CTI plans to submit a new drug application to FDA in mid-2008 for approval of pixantrone. The firm hopes to launch that product in 2009, Bianco said.