Data May Help Cancer Drug
Gain Approval for Wider Use
By RACHEL ZIMMERMAN
December 11, 2007; [WSJ] Page B11
New clinical-trial results showing that the blood-cancer drug Velcade increases remission rates in patients could boost its chances of winning regulatory approval for wider use.
Positive results of several clinical trials announced at a hematology conference in Atlanta on Sunday and yesterday sent shares of Millennium Pharmaceuticals Inc., which is based in Cambridge, Mass., and markets Velcade in the U.S., up 92 cents, or 6.1%, to $15.99 yesterday in 4 p.m. Nasdaq composite trading.
Velcade currently is approved in the U.S. to treat the blood cancer known as multiple myeloma in patients who have received at least one prior therapy. Millennium is seeking regulatory approval to allow the drug to be used as a first-line treatment. Chief Medical Officer Nancy Simonian says the company expects to apply to the Food and Drug Administration for the broader use this month.
Still, analysts said Velcade will continue to face stiff competition from Celgene Corp.'s Revlimid. That drug also is approved in the U.S. as a second-line treatment for multiple myeloma. Celgene, based in Summit, N.J., also is planning to seek broader usage of its drug.
New clinical trial results for Revlimid, combined with low-dose dexamethasone, a steroid, showed that over a two-year period the survival rate was 87%, compared with 75% for patients on the high-dose dexamethasone plus Revlimid.
Analysts seemed to think the results were more positive for the Millennium drug, which has been perceived as the underdog. Shares of Celgene fell $8.13, or 14%, to $49.18, also in Nasdaq 4 p.m. composite trading.
Analyst Jim Reddoch, of Friedman, Billings, Ramsey & Co. in Arlington, Va., says given the timing and scope of the new Velcade data, the treatment "has a clearer route to front-line." But he said doctors will still use Revlimid, which has the advantage of oral administration compared with Velcade, which is injected.
Over the weekend, results from a trial known as VISTA, sponsored by Millennium and Johnson & Johnson, showed that among patients with multiple myeloma that were previously untreated and ineligible for stem-cell transplantation, a standard drug combination that included Velcade caused 30% complete remission, compared with 4% when Velcade wasn't part of the regimen.
Millennium said last month it expects sales of Velcade to reach $265 million in the U.S. this year.
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