Lilly and Ono link up for sivelestat critical care drug

In announcing a first-quarter net income rise of 18% to $692.3 million(see page 6), Eli Lilly said that it has signed a letter of intent with Ono Pharmaceutical of Japan to develop and commercialize sivelestat for the treatment of acute lung injury and acute respiratory distress syndrome. Sivelestat would be the first neutrophil elastase inhibitor to reach the market and the first pharmaceutical compound to receive a license for these indications, says Lilly, which has rights to the drug in all markets exluding Japan, South Korea and Taiwan. Ono will receive its first milestone royalty from the collaboration immediately, notes the Marketletter's Tokyo correspondent.

Upon completion of the agreement, sivelestat will enter Phase II clinical development in the USA. In Japan, where it is awaiting regulatory clearance, the drug has been shown in clinical trials to reduce the amount of time required on a mechanical ventilator (by eight days), permit earlier discharge from intensive care and reduce the incidence of potentially life-threatening conditions. Sivelestat inhibits the action of elastase, a protein-degrading enzyme which is released from neutrophils and is thought to be involved in tissue damage and organ failure in acute inflammatory conditions such as acute lung injury.

In Japan, sivelestat will be marketed as Elaspol upon regulatory approval. The drug has been awaiting marketing clearance from Japan's Ministry of Health and Welfare since October 1997, and the latter requested additional data in December 1999. However, this does not necessitate additional trials and approval in Japan is likely this year.