Dendreon (DNDN) has been on Regulation SHO Threshold List for 186 consecutive days.
DNDN has a short interest of 30M out of 80M shares outstanding.
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BN 14:17 Dendreon Shares Jump on Inquiry Into Drug Rejection (Update2)
(Adds names of FDA panelists in sixth paragraph.)
By Luke Timmerman
Dec. 13 (Bloomberg) -- Dendreon Corp. shares jumped the most
in nine months in Nasdaq Stock Market trading as three members of
Congress called for hearings to investigate the rejection of the
company's experimental prostate cancer drug.
Dendreon rose 85 cents, or 15 percent, to $6.49 at 2:16 p.m.
New York time, after climbing as much as 33 percent. The stock
almost tripled on March 30 after a panel of advisers recommended
that the U.S. Food and Drug Administration approve the treatment,
Provenge. The agency rejected the drug in May.
Representatives Dan Burton, Michael Michaud and Tim Ryan
sent a letter requesting hearings to Representative John Dingell,
chairman of the House Committee on Energy and Commerce. The
lawmakers said they wanted an inquiry into potential conflicts of
interest for two members of the advisory panel who argued against
approval of Provenge. Michaud of Maine and Ryan of Ohio are
Democrats, and Burton is a Republican from Indiana.
``There is reason to believe that serious ethics rules were
violated'' by the two panel members, the lawmakers wrote in their
letter.
Dendreon won a 13-4 vote in favor of Provenge at the meeting
of cancer advisers to the FDA in March. While the FDA usually
follows the advice of its panels, the agency said on May 9 that
Dendreon would have to produce results from another study to win
approval. Dendreon lost almost $1 billion in market value.
Rival Drug
Two members of the panel who voted against Provenge --
oncologists Howard Scher of Memorial Sloan-Kettering Cancer
Center in New York and Maha Hussain of the University of Michigan
-- were cited by the lawmakers as having potential conflicts.
Scher is the lead investigator of a trial for a competing
experimental drug made by Novacea Inc. and advises a venture
capital firm that invests in that company, according to the
letter.
``We believe the FDA should not be appointing scientists
leading the testing of a rival drug for another firm onto an
advisory panel evaluating Provenge,'' the House members wrote.
They didn't specify their concerns about Hussain, who wrote to a
newsletter urging the FDA to reject Provenge after the panel
overruled her.
Patient advocacy groups have denounced the two FDA panel
members in letters and on Web sites since the agency's rejection
of Provenge in May.
A person who answered the phone in Scher's office referred
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Copyright (c) 2007, Bloomberg, L. P.
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inquiries to Memorial Sloan Kettering, which didn't respond
immediately. Hussain didn't immediately answer an e-mailed
request for comment.
`Congressional Pressure'
The next question is whether hearings are actually convened
by congressional leaders, said David Miller, president of Biotech
Stock Research, an independent equity research firm in Seattle.
``Congressional pressure is the only way Dendreon's Provenge
will make it to the market'' before data on another study becomes
available in the second half of 2008, Miller said today in a note
to clients.
If approved, Provenge would become the first treatment to
actively stimulate the immune system to attack cancer cells. The
drug showed an ability to prolong lives with minimal side effects
in one clinical trial, although it failed to reach the study's
main goal of slowing the spread of prostate cancer. If approved,
it could generate $1 billion annually in sales, analysts say.
--Editors: Larry Liebert, Jeanmarie Todd.
To contact the reporter on this story:
Luke Timmerman in San Francisco at +1-415-732-3135 or
ltimmerman@bloomberg.net
To contact the editor responsible for this story:
Reg Gale in New York at +1-212-617-2563 or
rgale5@bloomberg.net