J&J, AbbVie Shares Drop on Potential Drug Competition
February 05 2016 - 01:52PM
Dow Jones News
By Anne Steele
Shares of AbbVie Inc. and Johnson & Johnson took a hit
Friday after U.S. Food and Drug Administration briefing documents
hinted a cheaper competitor for the drug companies' blockbuster
anti-inflammatory treatments could be headed to market soon.
The FDA released the documents a week ahead of Celltrion Inc.'s
panel meeting suggesting the Korean pharmaceutical's proposed
biosimilar of Johnson & Johnson's Remicade is close enough to
be used to treat the same conditions, including arthritis.
The drug, CT-P13, is already approved and sold outside the U.S.
under trade names Inflectra and Remsima. It is licensed to Pfizer
Inc.
Data show Celltrion's treatment is "highly similar" to
U.S.-licensed Remicade and that "there are no clinically meaningful
differences" in terms of the safety, purity and potency, according
to the documents.
Shares of Johnson & Johnson fell 3.5% to $100.84. Global
sales of Remicade already have started to slump as the drug has
faced biosimilar competition in Europe. Investors fear that
Celltrion's lower-cost biosimilar could dent those sales
further.
Meanwhile, shares of AbbVie, which makes the arthritis drug
Humira, sank 5.9% to $53.44. Humira had U.S. sales of $8.4 billion
in 2015, representing 62% of AbbVie's U.S. revenue.
Credit Suisse Group AG analyst Vamil Divan said most notable is
the FDA's apparent comfort with extrapolating the clinical data
from studies of rheumatoid arthritis and ankylosing spondylitis to
support approval for the biosimilar for all conditions where
Remicade is currently approved.
"We believe this bodes well not just for CT-P13 but also future
biosimilars that are in development for a variety of blockbuster
branded products that are used across a range of indications," he
said.
As Leerink Partners LLC analyst Jason Gerberry points out, the
news is a positive for smaller biosimilar developers with battered
stocks of late. Shares of Coherus BioSciences Inc., down 50% over
the past three months, shot up 9% to $14.42 while shares of Epirus
Biopharmaceuticals Inc., down 34% over the past three months, rose
5.1%.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
February 05, 2016 13:37 ET (18:37 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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