* Both U.S., EU applications withdrawn for briakinumab
* Abbott shares slip 0.9 percent
(Adds analysts' comments, details of a previous study, other
By Lewis Krauskopf
NEW YORK, Jan 14 Abbott Laboratories Inc
(ABT.N) withdrew its U.S. and European applications for its
experimental psoriasis drug after regulators indicated the need
for more analysis and potential further studies.
The company plans to evaluate its next steps for
briakinumab, including resubmission at a later date, Abbott
said in a securities filing on Friday. An Abbott spokeswoman
declined to comment further on the regulators' concerns.
Abbott released results last October of a 52-week study of
317 patients with moderate to severe psoriasis which showed the
drug was significantly better than methotrexate in ability to
clear the unsightly, scaly and often painful skin patches
associated with plaque psoriasis -- a disease of the immune
However, analysts have pointed to cardiovascular concerns
arising from clinical studies. One study of nearly 1,500
patients found seven cases of major cardiovascular problems
with patients on briakinumab compared with none taking a
Briakinumab is a biotechnology drug that targets proteins
that have been linked to inflammation called IL-12/23. It is in
the same class as Johnson & Johnson's (JNJ.N) Stelara.
Abbott submitted its applications to Europe and U.S.
regulators late last summer.
Analysts have been expecting briakinumab sales to reach
$375 million in 2014, according to consensus expectations
provided by Thomson Reuters Pharma.
Wells Fargo analyst Larry Biegelsen said he had "relatively
modest" expectations for the drug -- $500 million in estimated
sales in 2015 -- due to the cardiovascular concerns, but "we do
see this setback as hurting sentiment towards (Abbott's) pharma
pipeline, with most of the remaining late-stage projects being
a few years from the market."
Edward Jones analyst Linda Bannister said the setback was
not material to her view of Abbott. The main issue confronting
Abbott is potential looming competition to its big-selling drug
Humira from an oral drug from Pfizer Inc (PFE.N), Bannister
Humira is approved to treat psoriasis, as well as
rheumatoid arthritis and other immune system disorders.
Abbott shares were down 41 cents or 0.9 percent at $46.96
in midday trading on the New York Stock Exchange.
(Reporting by Lewis Krauskopf, editing by Gerald E. McCormick,
Dave Zimmerman and Matthew Lewis)