Editor

In Greek mythology, Chiron was a centaur associated with healing - not a bad figure for a biotechnology firm to hook itself up with. But in the industry, what is Chiron Corp. known for? Quickly, now.

"There is no Chiron bullet point," said analyst Thomas Shrader, with Harris Nesbitt Gerard, putting his finger on a fact that has created some difficulty for would-be investors in the company. At least until they see the numbers.

For the fiscal year ending Dec. 31, Chiron's revenues jumped 38 percent to about $1.8 billion. Blood-testing and flu vaccine parts of the business helped boost pro-forma income to $297 million for the year. Oncology is the third piece of the Chiron pie, and Proleukin (aldesleukin), an interleukin-2 for metastatic melanoma and metastatic renal-cell cancer, racked up $115 million in sales.

The scrapping earlier this month of the tezacitabine program after a Phase II trial in gastroesophageal cancer failed to pan out brought new attention to the Chiron story. Tezacitabine, a nucleoside analogue acquired in the buyout of Matrix Pharmaceuticals Inc. a year ago, seemed promising despite poor performance in a Phase II study against colorectal cancer last year, Chiron said.

Shrader called tezacitabine "not a huge part" of the Chiron picture, "but [its failure] doesn't make them look very savvy," and the trouble with the drug shows how difficult it will be for companies such as Chiron and Genzyme Corp. to step into the arena of multibillion-dollar new cancer drugs - where Genentech Inc.'s Avastin (bevacizumab), the monoclonal antibody approved by the FDA in February for colorectal cancer, holds court.

Early this month, Chiron entered a deal with XOMA Ltd. to share antibody technologies focused on multiple products, splitting 70-30 development and commercialization expenses, including preclinical and clinical development, manufacturing and worldwide marketing costs. The companies will share revenues on the same basis, with Chiron getting 70 percent. For its share of development expenses, Chiron gave XOMA an initial payment of $10 million and a loan facility of up to $50 million.

Shrader expects flu vaccines to bring in about $432 million for Chiron in 2004. Blood testing will garner about $250 million. TOBI, Chiron's tobramycin solution for inhalation as a therapy for cystic fibrosis, should sell about $200 million. Betaseron (interferon-beta-1b) for multiple sclerosis will bring in about $144 million. Proleukin will yield about $127 million in 2004.

Due to start in May is a Phase III trial with tifacogin, described as a recombinant human tissue growth factor pathway inhibitor, for severe community-acquired pneumonia.

"With what they presented on the [conference] call, I view this as a high-risk trial," the skeptical Shrader told BioWorld Financial Watch. "They did a severe sepsis trial and basically saw no signal, and now they're trying to talk to people about why they're doing this trial."

He called the sepsis trial "noisy," and noted subgroup analyses "uncovered some interesting trends" but the subgroups were "somewhat arbitrary." Though he conceded he was not privy to all data involved in Chiron's decision to go ahead, Shrader wrote in a research report that "the drug's positive effects may have to be significant to outweigh safety concerns," such as the increase in bleeding in patients given tifacogin as compared to placebo.

Shrader's rating on the stock is "neutral." Is Chiron unfocused? Calling the company that would be "unfair," he said, since "Chiron makes money in health care."

Alex Hittle, analyst with A.G. Edwards, is even more upbeat. He agreed that Chiron has talked much about Proleukin lately partly because the company wants to have more presence in cancer.

"The other thing is that they are subject to a fair amount of pressure from investors to do more on their biopharmaceutical side," Hittle said. "They're really good at vaccines and blood testing, but those are both viewed as sort of second-tier businesses. There's a whole school out there that, by golly, wants the company to make money selling [more] drugs."

About tifacogin, he said, "I thought they made quite an interesting argument that this is worth a go, and they do have some [other] stuff rattling around."

A Phase III trial with the dry-powder formulation of TOBI is expected in the first half of this year, as well as a new drug application submission for inhaled cyclosporine. Also slated for 2004: completion of a Phase II trial that combines Proleukin with Rituxan (rituximab) for low-grade non-Hodgkin's lymphoma, and the start of a Phase II trial with the same combination in the same indication, in treatment-na ve patients. Rituxan is from Genentech and Biogen Idec.

Chiron also expects to bring on additional capacity for making flu vaccines this year, which will add to its growing profile in that space, said John Gallagher, the company's media relations manager.

An interim peek at the tifacogin results for pneumonia could happen in August 2005, with final data possibly in the fourth quarter of 2006.

In the meantime, other firms might be known for high-profile marketed drugs, but Chiron will keep going its diversified way.

"This is the root of our having a buy' [rating] on them, and at the same time it's why they frequently don't get quite the same level of interest as some of the other companies," Hittle told BioWorld Financial Watch. "It ends up being more complicated to follow. There's no one piece you're really going to live and die on."