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SAN FRANCISCO Remember Zevalin? The once-trumpeted radioactive immune therapy for non-Hodgkin s lymphoma from IDEC Pharmaceuticals Inc. (now Biogen Idec Inc.) won approval in February 2002. Hopes ran high, with sales projections in the $500 million range, but performance fell short. Biogen Idec reported $18 million in worldwide sales last year, $16.4 million of that amount in the U.S.

Cell Therapeutics Inc. has big plans for the drug, said James Bianco, CEO of CTI, before presenting at the Biotechnology Industry Organization s InvestorForum in the Palace Hotel last week. In August, CTI agreed to pay $10 million for Zevalin, plus as much as $20 million in royalties. Treatment approaches have changed, now that oncology practices have invested in PET scan technology with nuclear medicine specialists or radiation oncologists onsite. In the old days, doctors had to send patients to hospitals for Zevalin therapy, which meant the physicians would not get reimbursed from Medicare or private insurers. So the patients took chemotherapy, even though as much as 55 percent of chemo patients fail to get complete remission of their disease.

Now, encouraging anecdotal evidence of Zevalin s efficacy has begun to surface, along with similar good news for NHL patients related to Bexxar (tositumomab), the radiolabeled monoclonal antibody sold by GlaxoSmithKline plc. Originally developed by Corixa Corp. and taken over by partner GSK in late 2004, Bexxar like Zevalin apparently is knocking down the disease after a single course of therapy. CTI, aiming to push Zevalin into the front-line setting, projects peak annual Zevalin sales of $250 million.

Zevalin (ibritumomab tiuxetan), consisting of a monoclonal antibody linked to the radioisotope Yttrium-90 to target the CD20 antigen on mature B cells and B-cell tumors, won clearance specifically for relapsed or refractory low-grade, follicular or transformed B-cell non-Hodgkin s lymphoma, including those with disease not responding to therapy with Rituxan (rituximab), Biogen Idec s NHL compound that is co-promoted in the U.S. with Genentech Inc. Rituxan is the top-selling cancer drug worldwide, tallying worldwide sales in 2006 of $4 billion.

It was tough for Biogen Idec when you have a drug like Rituxan, from an economics and pure business standpoint, Bianco told BioWorld Financial Watch. Rituxan is a very easy-to-use drug that s making physicians a lot of money, with a low toxicology profile and it works. What we re now beginning to learn is that Zevalin may give you that extra boost.

With partner Schering AG, Biogen Idec a year ago started a Phase III trial of Zevalin in aggressive lymphoma, aiming to enroll about 400 patients to test the efficacy and safety of Zevalin vs. observation in patients with diffuse large-B-cell lymphoma who are in complete remission or unconfirmed complete remission after first-line CHOP-Rituxan therapy. Primary endpoint: overall survival.

As long ago as the 2005 meeting of the American Society of Hematology, Biogen Idec reported data showing that patients might benefit from earlier and consolidated Zevalin use. Recent success drew the attention of the New York Times over the summer, headlined, Market Forces Cited in Lymphoma Drugs Disuse.

Bianco said it s not quite as simple as doctors avoiding Zevalin because they make more money with longer courses of therapy, such as Rituxan and chemo.

I think it s more of a matter of what they re comfortable with what they currently do in their practices, he said. It s their reflexive action. We re saying, Here s an alternative or a supplement. You save money on the practice-efficiency side, because it s a single dose.

Another firm presenting at the BIO event was Spectrum Pharmaceuticals Inc., which last month started its second pivotal Phase III trial with Eoquin (apaziquone) as a post-operative adjuvant therapy in patients with non-invasive bladder cancer, under a special protocol assessment deal with the FDA.

The pivotal program is designed to prove the chemotherapy product s mettle as part of a front-line regimen with transurethral resection, the current standard treatment. Superficial bladder cancer is not quickly fatal, but tends to recur, hence the need for costly, regular surgical procedures in which physicians scrape away the bladder s mucus membrane.

They re getting a catheter, they re getting surgery, and even when they re being monitored, they re getting essentially scoped every three months, noted Russell Skibsted, chief business officer for Spectrum.

Under the SPA, in both trials, the primary endpoint must show a statistically significant difference in the rate of tumor recurrence between the treatment arm and placebo arm by the second year. Other endpoints include time to recurrence, progression to higher stages or grades of disease, number of recurrences, disease free interval, disease free survival and overall survival.

But the first drug that comes to mind with Spectrum is satraplatin, partnered with GPC Biotech AG. Satraplatin met with misfortune over the summer, when an FDA advisory panel recommended waiting for overall survival data, expected in January, before taking action on the platinum-based therapy for hormone-refractory prostate cancer.

The panel s vote was certainly not what we were expecting, Skibsted said, pointing out that Spectrum is paying no costs for the drug, and has gained $4 million from the deal before this year, along with $7 million in 2007. We don t have long to wait for the overall survival results from GPC, and Spectrum is encouraged by the data we ve seen so far, with meaningful clinical activity.

Spectrum started arbitration against GPC in December of last year, claiming a violation of the license agreement, and hearings were held in July, with final arguments in August and a final decision expected before the end of this month.

Meanwhile, Skibsted pointed to Spectrum s 11-drug pipeline at various stages of development, with three compounds that could be on the market by next year and the management team, which includes people who have been involved in bringing forward such drugs as cisplatin, carboplatin and Taxol (paclitaxel, Bristol-Myers Squibb Co.).

It s not just something where we try to collect letters on the ends of peoples names, he said, citing a number of MDs have been in practice, they ve treated patients in their careers, [and] they know what to look for in drugs.

The BIO conference ran Tuesday through Thursday.