FDA panel's tamoxifen nod seen lifting Lilly drug
Wednesday September 2, 2:25 pm Eastern Time
By Kevin Drawbaugh
CHICAGO, Sept 2 (Reuters) - The Eli Lilly & Co. (LLY - news) drug Evista is likely to get a boost from a favorable ruling Wednesday on the Zeneca Group Plc (ZEN - news) drug tamoxifen by a regulatory panel in Washington, analysts said.
Both compounds come from the same chemical family and are seen by some as the first drugs able to prevent breast cancer.
A U.S. Food and Drug Administration advisory committee voted to recommend approval of Zeneca's request to market tamoxifen as a breast cancer preventative.
The oncologic drugs advisory committee's support of tamoxifen is not binding, but the FDA usually heeds committees' advice, making tamoxifen's ultimate approval likely.
''That should be very helpful to Lilly,'' said EVERENSecurities analyst Jeffrey Kraws.
At midday on the New York Stock Exchange, Lilly shares were up 1-2/16 at 70-9/16 for a gain this year of about 2 percent, well off the U.S. drug industry average year-to-date gain of more than 20 percent. Shares in Zeneca were up 2-5/8 at 40-1/2, lifted by the committee ruling, analysts said.
Both tamoxifen and Evista are selective estrogen receptor modulators, or SERMs, thought to alter the action of the hormone estrogen in females. Tamoxifen is already sold by Zeneca, a British company, as an anti-cancer drug under the brand-name Nolvadex.
Evista, known generically as raloxifene, is sold by Lilly as a preventative for bone-brittling osteoporosis. But its sales since launch in January have not met market expectations, and Lilly's
stock has suffered as a result, making Wall Street hungry for any hopeful signs on new uses for Evista.
''Because there's been so much disappointment, any glimmer of good news would have an impact,'' said Cowen & Co. pharmaceutical industry analyst Stephen Scala.
A National Cancer Institute study of 13,388 women at high risk for breast cancer showed tamoxifen reduced incidence of the disease by 45 percent. The results were so compelling that the study was halted early in April to allow patients in the control group to switch from dummy pills to tamoxifen.
Concerns about the drug's side-effects lingered, however, with a group of cancer activists urging the FDA panel to reject Zeneca's request.
Dr. Samuel Epstein, chairman of the Cancer Prevention Coalition and a professor at the University of Illinois, submitted a statement to the committee opposing Zeneca.
''Tamoxifen is a highly potent carcinogen,'' Epstein said in his statement. ''Disturbingly, women in the (cancer institute) trial were not informed of the clear evidence of these risks.''
He added, ''Additionally, there are serious questions as to whether tamoxifen actually reduced the incidence of breast cancer or merely delayed its onset. Two articles published on July 11 in the highly prestigious journal, The Lancet, reported no evidence of breast cancer prevention by tamoxifen in two major European trials.''
Tamoxifen is a 35-year-old drug that no longer has patent protection in Europe and is scheduled to lose its patent protection in the United States in 2002, limiting its potential as a major new source of
revenue for Zeneca, analysts said.
Indianapolis-based Lilly said it will begin a clinical trial this fall directly comparing Evista and tamoxifen. The trial will involve 20,000 women at increased risk for breast cancer.
Interim data from earlier breast cancer trials with Evista showed it reduced the incidence of the disease without some of the side-effects seen in tamoxifen trials. |
