Chiron will initiate a pivotal, 1,500 patient trial of tifacogin in sepsis in the first half of the year, Chiron Chairman & CEO Sean Lance said during a Feb. 8 conference call announcing the company's sales and earnings for 1999.

Chiron and Searle are jointly developing tifacogin, a tissue factor pathway inhibitor. Searle CEO Alan Heller has predicted a 2002 launch for the product.

FDA "agreed to help plan for a pivotal Phase III trial using TFPI to treat severe sepsis. We expect to begin that trial in the first half of this year," Lance said.

The trial will resemble the design of the product's Phase II study, Lance said. It will be a multinational study involving about 1,500 patients. The primary endpoint will be 28-day mortality, and secondary endpoints will include organ dysfunction. The trial and subsequent data analysis will take around two years, Chiron said.

Other pipeline goals for 2000 include "a go-no go" decision regarding IGF, Lance said. Enrollment in a Phase II U.S. study for the insulin-like growth factor has been slower than anticipated and the company has yet to determine if it will proceed with development. A decision could be made in the first half of the year, he said.

For 1999, Chiron reported income from continuing operations of $128.4 mil. vs. $76 mil. for 1998. Total revenues for 1999 were $763 mil. versus $737 mil. in 1998. Product revenues increased by $23 mil. as collaborative revenues decreased by $14 mil.

Proleukin sales were $112 mil. for 1999, a 20% increase over the prior year, Chiron VP & CFO James Sulat reported. Chiron credits this growth to the "broadening of our cancer franchise... [and] the expansion into HIV," Lance said. Proleukin (aldesleukin), previously approved for metastatic renal cell carcinoma, received an expanded indication for metastatic melanoma in 1999.

In 2000, "we will initiate a Phase I clinical trial to study Proleukin in combination with other proven cancer therapies," Lance said. "In HIV, we will concentrate on achieving at least 50% enrollment" in a Phase III Proleukin trial, Lance said.

The company's goal for Betaseron is an expanded U.S. label for secondary progressive multiple sclerosis. During 1999, the product received approval for this indication in Europe and Canada. The U.S. application was submitted in June 1998. Betaseron (interferon beta-1b), also approved for treatment of patients with relapsing-remitting MS, is manufactured by Chiron and marketed in the U.S. by Berlex Laboratories and in Europe as Betaferon by Schering AG.

"Betaseron sales, including the royalty earned from the sale of Betaferon by Schering in Europe, were $96 mil. for 1999, a 4% increase over the prior year," Sulat said.

"We are hopeful to gain new market penetration in secondary progressive MS based on a superior safety and tolerability profile," Lance said. Despite "a positive FDA panel recommendation recently," Immunex' Novantrone "still looks to me like a therapy of last resort given the toxicity profile and given the limitations in terms of how much of it patients can take....To the extent that our secondary progressive approval is forthcoming, people will see Betaseron as a preferable approach to treating those patients over the Novantrone product," Lance maintained.

Total revenues for Chiron's biopharmaceutical business were $188 mil. for 1999, a decrease of $14 mil. from 1998. "The expected absence of PDGF sales in 1999 [was] offset by about a 13% increase in other biopharmaceutical product sales during the year," Sulat said. PDGF is the active ingredient of Ortho-McNeil's Regranex Gel (becaplermin). Ortho-McNeil introduced the diabetic foot ulcer treatment in the winter of 1998, producing the drug from materials it had purchased in 1998. Sales of PDGF are expected to resume in the second quarter of this year, Lance said.

Chiron's vaccine sales for 1999 were $209 mil., up 18% from 1998. However, the "vaccines business was not profitable in the quarter and it was not profitable for the year," Sulat said. Chiron's strongest vaccine market presence is in Germany and Italy, with only one U.S. approval - RabAvert - for treatment of rabies.

"We expect profitability and pretty substantial profitability in vaccines if the Men C approval is forthcoming," Lance said. In the U.K., Chiron expects approval shortly for its meningitis C vaccine Menjugate, submitted in August. The U.K. government has requested a March shipment of the product. Menjugate could generate revenue of $100 mil. in 2000, the company estimated.

Chiron/Searle Tifacogin Will Begin Two-Year, 1,500 Patient Trial In Sepsis

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