By Matthew Willett
Cell Therapeutics Inc. said its apoptosis-inducing leukemia therapeutic Trisenox (arsenic trioxide) received FDA approval for treatment of acute promyelocytic leukemia.
The company plans to market the drug independently, using a 16-person sales force.
Trading in the company's stock (NASDAQ:CTIC) was suspended earlier Tuesday pending the news, and closed up $4.75 at $52 after trading resumed.
Company officials said the approval is one that could have far-reaching implications in oncology therapy in this and other indications.
"I think it's fair to say the FDA worked expeditiously and diligently," CTI CEO and President James Bianco said. "They worked through the Fourth of July holiday and worked hard at getting us through the package insertion issues and the audits within the deadline, and we're very pleased with the outcome."
Bianco said the company has already put its sales force into place. Two directors, one on each coast, will supervise the 16-person sales force, each of whom is called an oncology account manager.
"We currently have 16 oncology account managers in the field, and one East Coast and one West Coast director," Bianco said. "We have the infrastructure in place and what we call demand creation ability. Each of these account managers has about eight years experience, and their managers have about 10 years experience each, and they're all out of companies like SmithKline Beecham, Aventis and Bristol Myers Squibb Co., companies with known oncology experience, so we should be in a position to ship drugs to our customers within the first week of October."
Bianco said the ability to market and distribute the drug independently should make it more profitable.
"The expectation at this time is that it's an attractive commercial opportunity for the company," he said. "We think we understand the oncology space well, and with our sales force in that market able to create demand for the product we think we can accomplish a lot."
Bianco said the market for Trisenox is between 1,500 and 2,000 patients in the U.S. annually. He added that Europe contains a similar market.
He said the company anticipates pricing the therapy from about $12,000 to $16,000 per patient annually. At the high end, the company stands to gross about $32 million in the first year of commercialization.
He added that the company has plans for expansion into the European market, either through a partnership, which the company is currently seeking, or independently.
"We're actually preparing to file our marketing application [in Europe] in the fourth quarter of this year, so the product approval may come as early as next year," he said.
CTI also plans to pursue a clinical study intended to expand Trisenox's indication to include multiple myeloma and lymphoma, among other blood cell and solid tumor cancers.
"There's a fair amount of clinical data already indicating preliminary results in those indications," Bianco said. "Our challenge is to put together a robust clinical program that pursues each of these indications as extensions to the label indication."