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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (25806)	9/28/1998 2:35:00 PM
From: Robert L. Ray	Read Replies (2) \| Respond to of 32384

Novo Nordisk is getting hammered today on news that they are suspending clinicals on their SERM because of side effects. An anchor on CNBC (can't remember which one) speculated that Novo is now in the market to aquire/partner SERM products from other companies. biz.yahoo.com Novo Nordisk Discontinues 0steoporosis Development Program for Levormeloxifene BAGSVAERD, Denmark, Sept. 26 /PRNewswire/ -- At a meeting with clinical investigators today in Atlanta, US, Novo Nordisk A/S (NYSE: NVO - news) announced that it has decided to discontinue the current Phase 3 trials for levormeloxifene in osteoporosis treatment and prevention. Levormeloxifene is a partial estrogen receptor agonist (a so-called SERM). Earlier this year, an intensified safety surveillance of gynecological adverse events was initiated following observations of increased endometrial thickness in connection with the use of levormeloxifene. In connection herewith, an increased frequency of urinary incontinence and utero-vaginal prolapse has been observed. Both urinary incontinence and utero-vaginal prolapse -- which have not been related to endometrial thickening -- are common findings in the elderly female population. The incidence of these adverse events was, however, substantially higher with levormeloxifene than with placebo. ''While our analyses demonstrated the desired efficacy on bone and lipids at Phase 3 doses, we have concluded that the overall risk-benefit profile of the compound is unfavorable for the osteoporosis indication. It is therefore in the best interest of the patients to discontinue our ongoing studies. However, levormeloxifene may still be of potential interest in other indications, and we are currently assessing outlicensing options,'' said Lars Rebien Sorensen, corporate executive vice president and head of Health Care at Novo Nordisk. Arrangements are now being made for trial centers to contact patients and to ensure an orderly closure of the trials. 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 variety of other pharmaceutical products. Furthermore, the company is the world's largest producer of Industrial enzymes. Headquartered in Denmark, Novo Nordisk employs approximately 14,600 people in 61 countries and markets its products in 179 countries. Its B shares are listed on the stock exchanges in Copenhagen, London and Zurich. Its ADSs are listed on the New York Stock Exchange under the symbol ''NVO.'' For further company information, visit Novo Nordisk on the World Wide Web at novo.dk. SOURCE: Novo Nordisk A/S