IDEC Pharmaceuticals Corp. is dropping the development of IDEC-114 for psoriasis after a preliminary review of Phase II data, saying its focus for the drug now will be on ongoing work in non-Hodgkin's lymphoma.
The two Phase II trials in moderate to severe psoriasis gave data that did not support further development in that indication. The company said it plans to present detailed results from the studies later in a peer-reviewed venue.
"We are obviously disappointed that the indication in psoriasis was not more positive, but we're pursuing other indications," said Vince Reardon, director, corporate communications at IDEC.
The news dropped IDEC's stock (NASDAQ:IDPH) down $1.77 Thursday to close at $39.10. The drop was similar to the Nasdaq Biotechnology Index. William Tanner, analyst with Leerink Swann & Co. in Boston, said in a research note that IDEC-114 wasn't highly regarded in psoriasis anyway.
"While this may appear to be a setback in the pipeline, we do not believe that IDEC-114 is a significant driver and have not included it in our financial forecasts," Tanner said in his note. "The drug candidate was not considered overly promising for treatment of psoriasis according to physicians with whom we spoke recently."
IDEC-114 is a primatized anti-CD80 monoclonal antibody designed to inhibit the binding of the B7-1 ligand on antigen-presenting cells to the CD28 receptor on T cells and therefore block the second signal for inflammatory T-cell activation. T cells, when activated irregularly, are thought to lead to many autoimmune diseases, giving IDEC-114 potential in an array of indications.
But apparently not psoriasis. With that indication cut, IDEC will move its non-Hodgkin's lymphoma program for IDEC-114 to the front. Already completing Phase I trials of the product, IDEC is planning to accrue patients in a Phase I/II combination trial of IDEC-114 and its marketed drug, Rituxan, in relapsed low-grade non-Hodgkin's lymphoma (NHL).
"We are conducting a Phase I in NHL," Reardon told BioWorld Today. "We're beginning a Phase I/II trial [in combination] with Rituxan, so that's the next step. Meanwhile, we're looking at other autoimmune indications for 114. There is still a lot of life in the development program."
Rituxan (rituximab), approved in 1997 for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma, continues to grow into its blockbuster label. The product sold $257 million in the second quarter, although it is co-promoted by Genentech Inc., of South San Francisco, in the U.S. through a joint venture that received $92.5 million of that money. Tanner said in his note that IDEC receives about 30 percent of Rituxan sales through the Genentech partnership. The drug is partnered abroad with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Zenyaku Kogyo Co. Ltd., of Japan.
Zevalin, a radioimmunotherapy product approved in the U.S. in February for certain B-cell non-Hodgkin's lymphomas, is owned in the U.S. by IDEC alone. In the second quarter, Zevalin brought IDEC $3.3 million. The drug is not covered by Medicare and that has hurt sales, Tanner said in his note, but coverage is scheduled to begin in October and thus could help ramp up U.S. figures. Tanner estimates Zevalin could earn IDEC as much as $15 million by year's end and $170 million in 2004.
Reardon said Medicare coverage is scheduled to begin Oct. 1, and said the company is "certainly hopeful" that the coverage will cause a spike in Zevalin sales.
"A lot of hospitals have not been able to treat Medicare patients [with Zevalin]," he said.
Similar to IDEC-114, the company's IDEC-151 is in Phase II trials, in this case for rheumatoid arthritis, and what arises out of that trial could be crucial for that drug.
"We'll be presenting top-line results for that trial in the next month or so," Reardon said. "It will be like the IDEC-114 news - a press release saying if we are moving forward or if we are not."