Coulter to file for Bexxar approval soon
Marketletter via NewsEdge Corporation : Coulter Pharmaceutical has told attendees at a US Bancorp Piper Jaffray conference in Minneapolis that it plans to file for approval of its non- Hodgkin's lymphoma therapy Bexxar (iodine I131 tositumomab) with the US Food and Drug Administration at the end of June. The announcement pushed the shares up $2.13 to $23.13.
The regulatory agency said that the company could file the application in stages as each segment was completed, but chief executive Michael Bigham told the conference that Coulter will submit the entire application on or about June 30. An FDA advisory panel could review the application by October, he added, and Bexxar may in theory be on the market by the end of the year. Analysts say that the drug could generate $240 million in annual sales by 2002. SmithKline Beecham will copromote Bexxar with Coulter in the USA, with the latter contributing approximately 30 sales staff to the venture.
Meantime, the company will request FDA permission to begin clinical trials of its first solid-tumor treatment, a tumor activated peptide prodrug version of doxorubicin, during the last quarter of 1999.
Bexxar ahead of the pack
The Coulter filing would put Bexxar ahead of competitor IDEC's Zevalin (ibritumomab tiuxetan). The latter, a follow-up to Rituxan (rituximab), is expected to be filed in the first half of 2000 for patients with relapsed or refractory, low-grade or follicular, B-cell NHL, according to William Rohn, chief operating officer at IDEC who was speaking at the same conference.
In Phase III trials, Zevalin is used in tandem with Rituxan, which acts as a pretreatment to clear circulating B cells from the body. This enables Zevalin to deliver radiation from its yttrium90 isotope to lymphoma tumors. A company spokesman told the Marketletter that Zevalin differs from Bexxar in that the latter uses a mouse monoclonal antibody as a pretreatment and delivers radiation using iodine I131.
IDEC is also investigating the efficacy of Rituxan in combination with standard chemotherapy in treating some of the more aggressive forms of NHL. If studies demonstrate that the combination can improve response rates from 40% to 50%-60%, Rituxan combination therapy will "become the new standard of care " and add about $400 million in annual sales on top of existing uses for the drug, said Mr Rohn.