Novo Nordisk Ends Levormeloxifene Trials, Cites Safety Concerns

At a recent meeting with clinical investigators, US, Novo Nordisk A/S announced that it will discontinue the current Phase 3 trials for levormeloxifene in osteoporosis treatment and prevention. Levormeloxifene is a partial estrogen receptor agonist (a so-called SERM). A safety study conducted earlier this year revealed that Levormeloxifene can cause an increased frequency of urinary incontinence and utero-vaginal prolapse. Both urinary incontinence and utero-vaginal prolapse are common findings in the elderly female population. The incidence of these adverse events was, however, substantially higher with levormeloxifene than with placebo.

A provision to cover the expected costs related to the termination of the project will be taken in the third quarter of 1998 and offset in the net one-time income of DKK 300 million (USD 47 million) seen in the first half of 1998. Consequently, Novo Nordisk's expectations for operating profit, excluding net one-time income, for the year 1998 remain unchanged from those announced in Novo Nordisk's profit statement for the first half of 1998.

Novo Nordisk A/S is the world leader in diabetes care and also manufactures and markets 47 varieties of other pharmaceutical products.

For more information: Susan Toth Jackson, Novo Nordisk. Tel: 212-867-0123.