SEC Subpoenas Elan For Records Of Tysabri Infection Cases
September 29 2009 - 1:59PM
Dow Jones News
Irish drug maker Elan Corp. Plc (ELN) said Tuesday it received a
subpoena from the U.S. Securities and Exchange Commission seeking
information related to disclosures last year about Elan's
multiple-sclerosis drug Tysabri and an experimental Alzheimer's
disease drug.
Elan disclosed in a regulatory filing it received the subpoena
Sept. 24 from the SEC's New York office, and it intended to provide
the SEC with materials in connection with the commission's
investigation into Elan.
The exact nature of the SEC's investigation wasn't immediately
known, and a commission spokesman declined comment. An Elan
spokeswoman couldn't immediately be reached.
The subpoenas concern two separate announcements related to Elan
last year. On July 31, 2008, Elan and its marketing partner, Biogen
Idec Inc. (BIIB) notified regulatory agencies of two confirmed
cases of a rare brain infection called progressive multifocal
leukoencephalopathy, or PML, in multiple-sclerosis patients treated
with Tysabri. Tysabri had previously been withdrawn from the market
due to PML risk, then relaunched, and the companies have monitored
the side effect closely.
Separately, two days earlier, researchers presented the results
of a mid-stage patient trial of bapineuzumab, an Alzheimer's drug
Elan co-developed with Wyeth (WYE), at a medical-meeting in
Chicago. Wyeth and Elan said the data supported their prior
decision to move the drug into late-stage trials, which are still
underway.
The full data presentation for bapineuzumab disappointed many
investors, who felt it was less impressive than the preliminary
findings Wyeth and Elan had included in a June 2008 press
release.
Elan's American depositary receipts were quite volatile during
this period, including a plunge of more than 70% over three days in
late July and early August 2008.
Johnson & Johnson (JNJ) recently acquired Elan's rights in
the Alzheimer's disease partnership with Wyeth.
Spokespeople for J&J and Biogen declined to comment. A Wyeth
spokesman couldn't immediately be reached.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com