Chiron Corporation has plans for a Phase III trial for tifacogin in patients with severe community-acquired pneumonia. Severe community-acquired pneumonia is defined as pneumonia contracted outside of a hospital setting that requires the patient's admission to an intensive-care unit. Tifacogin, developed by Chiron, is a recombinant form of tissue factor pathway inhibitor, or TFPI, a naturally-occurring protein in the body.
"The unmet medical need for this disease is substantial," said Howard Pien, president and CEO of Chiron. "Severe community-acquired pneumonia presents a well-defined clinical diagnosis and a homogeneous set of patients. This represents an excellent commercial opportunity for the company, one which would allow us to leverage the expertise of our existing sales force. Recent advances in tissue factor biology, along with a thorough analysis of the previous Phase III study of tifacogin in severe sepsis, give us the confidence to begin this new trial."
Chiron had been co-developing tifacogin with Pharmacia, which has since been acquired by Pfizer. Chiron has acquired all of Pfizer's interest in tifacogin, in return for which Pfizer will receive royalties on sales of tifacogin. Chiron announced in November 2001 that a Phase III study for tifacogin in severe sepsis, conducted in collaboration with Pharmacia, failed to meet its primary endpoint of 28-day, all-cause mortality.