Shire Shares Jump on Trial News of Possible Blockbuster
28 October 2015 - 12:30AM
Dow Jones News
By Denise Roland
LONDON--Shares of Shire PLC jumped more than 5% after the
pharmaceutical company said it would resubmit its potential
blockbuster dry-eye drug lifitegrast to U.S. regulators, based on
positive results from a recently completed clinical trial.
Earlier this month, the Food and Drug Administration decided
against an early approval for the drug, saying it needed to see
more clinical-trial evidence.
The Dublin-based company said that, in the recently completed
phase-three trial called OPUS-3, the drug improved patient-reported
symptoms of dry-eye disease compared with a placebo as early as two
weeks into treatment, with the effect lasting throughout the 12
weeks of the trial.
Shire said it planned to use the data as part of the
resubmission of lifitegrast in the first quarter of 2016 and that,
if approved, the drug could still launch next year. The company
said it would also provide more data on the quality of the drug in
response to questions posed by the FDA during the initial
review.
Philip J. Vickers, head of research and development at Shire,
said he believed the data from OPUS-3 "will satisfy the FDA's
request for an additional clinical-data study."
Ronny Gal, an analyst at Bernstein, said the new data should be
enough for approval, which he expects to come in the third quarter
of 2016. The "FDA had clearly tied approval of lifitegrast to
OPUS-3, which made sense given Shire were looking for both a signs
and symptoms claim on the label," he said.
Shire conducted OPUS-3 "as a safety blanket," according to Chief
Executive Flemming Ornskov, to add force to evidence that
lifitegrast was the first ever drug to treat the symptoms of
dry-eye disease.
An earlier study, called OPUS-2, had already demonstrated that
the drug relieved dry-eye symptoms but failed to show lifitegrast
treated the physical signs of the disease. Another phase-three
study, OPUS-1, generated the opposite result, showing that
lifitegrast treated signs but not symptoms.
Mr. Ornskov said OPUS-3 was important because it showed the
result in symptom-relief could be replicated. All three clinical
trials together will form the basis for the resubmission, he
said.
The success of lifitegrast is a key plank in Shire's ambition to
increase sales to $10 billion by 2020 from around $6 billion
currently. Analysts have forecast that peak annual sales of the
drug, which is the first shown to relieve the symptoms of dry-eye
disease, could hit $1.5 billion.
In London trading, Shire shares were up as much as 7.4% to
GBP49.50 ($76.03) on the news and at midsession were up 5.6% to
GBP48.68.
Write to Denise Roland at Denise.Roland@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 27, 2015 09:15 ET (13:15 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
Shire (LSE:SHP)
Historical Stock Chart
From Apr 2024 to May 2024
Shire (LSE:SHP)
Historical Stock Chart
From May 2023 to May 2024