* Both U.S., EU applications withdrawn for briakinumab
* Abbott shares slip 0.9 percent (Adds analysts’ comments, details of a previous study, other background)
By Lewis Krauskopf
NEW YORK, Jan 14 (Reuters) - 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 system.
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 placebo.
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 said.
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)