After acquiring full rights from Pfizer Inc., Chiron Corp. is looking to resurrect a compound that once appeared dormant.
The Emeryville, Calif.-based company reported plans to begin a Phase III trial of tifacogin in patients with severe community-acquired pneumonia (CAP), a condition contracted outside a hospital, which then requires intensive-care treatment. About 30 percent of such patients die, Chiron said, and no drugs are approved for the reduction of mortality in severe CAP.
"This will be a very homogenous population, a much more well-characterized and well-defined population, as opposed to sepsis," John Gallagher, Chiron's manager of media relations, told BioWorld Today. "And you're getting people before they get sepsis, so I think there's a better opportunity for intervention."
Two years ago, a Phase III study of the same drug in treating severe sepsis did not hit its primary endpoint. Findings from that trial, conducted in collaboration with Pharmacia Corp., showed that tifacogin failed to meet the main endpoint of reducing 28-day all-cause mortality.
The double-blinded, placebo-controlled trial, which included about 2,000 patients with severe sepsis from 16 countries, raised no safety issues. (See BioWorld Today, Nov. 26, 2001.)
But Chiron said that further analysis of the data, as well as advances in tissue factor biology, support its plans to push for commercialization in a different direction. That sentiment was echoed by industry analyst Eric Schmidt, with SG Cowen Securities Corp. in New York.
"By pursuing severe CAP, Chiron hopes to catch patients at a less severe stage in the sepsis cascade, potentially increasing the chances of showing efficacy," Schmidt wrote in a research note. "Management also noted that severe CAP patients represent a more homogenous and well-characterized population, potentially reducing noise seen in a broader sepsis population."
Tifacogin is a recombinant form of tissue factor pathway inhibitor, or TFPI, a naturally occurring protein in the body.
Gallagher said Chiron has submitted a proposed trial protocol to the FDA and could get a response before year's end. He declined to provide specifics as to the study's design but said patient dosing could begin in the spring, should the agency sign off on the plan.
Like the prior Phase III study, its endpoint will be 28-day all-cause mortality, Gallagher added.
He declined to add any further details related to the financial arrangement between Chiron and Pfizer, though the former said it would hand over undisclosed royalties on eventual sales to the latter. Peapack, N.J.-based Pharmacia's co-development rights transferred to Pfizer when the New York-based pharmaceutical giant swallowed Pharmacia.
Separately, Chiron reported quarterly earnings that topped consensus projections.
Its pro forma income totaled $117 million, or 60 cents per share, ahead of analysts' projections of 53 cents and last year's third-quarter earnings of 46 cents per share. On a GAAP (generally accepted accounting principles) basis, Chiron recorded a $20 million loss, or 11 cents per share, due to a write-off associated with its $880 million acquisition of PowderJect Pharmaceuticals plc. (See BioWorld Today, May 20, 2003.)
Chiron's cash purchase of the Oxford, UK-based vaccine maker boosted its quarterly revenue 47 percent to $540 million, a figure also aided 6 percent by favorable foreign exchange rates. Excluding PowderJect's revenues and the foreign exchange effect, all other revenues increased 10 percent in the quarter.
Among its three business units, Chiron's vaccines division produced net third-quarter sales of $263 million, compared to $125 million a year ago. Its biopharmaceuticals division reported net product sales and Betaferon interferon beta-1b royalties of $126 million, compared to $115 million, while total blood testing revenues climbed to $109 million from $89 million a year ago.
Chiron ended the quarter with about 186.7 million shares outstanding, as well as reserves of $697.7 million in cash and short-term investments.
The company reaffirmed its prior full-year pro-forma guidance to be at the upper end of the $1.40 to $1.50 range. In the coming year, Chiron forecasted pro-forma earnings per share to range between $1.80 and $1.90, bolstered by product sales between $1.5 billion and $1.6 billion and revenues between $1.9 billion and $2 billion.
On Thursday, its shares (NASDAQ:CHIR) dropped $2.34 to close at $54.31.