Valeant Gets FDA OK for Anticonstipation Tablets Developed by Progenics
July 19 2016 - 9:02PM
Dow Jones News
By Josh Beckerman
Valeant Pharmaceuticals International Inc. has received U.S.
Food and Drug Administration approval for Relistor tablets to treat
opioid-induced constipation for patients with noncancer pain.
An injectable form of Relistor, which was developed by Progenics
Pharmaceuticals Inc., was approved in 2008. In 2011, Progenics
licensed Relistor rights in most markets to Salix Pharmaceuticals
Ltd., which was sold to Valeant in 2015 for $11.1 billion.
Progenics shares rose 36% to $6.74 in after-hours trading.
Valeant was up 4% to $24.50.
Valeant expects to begin U.S. sales of Relistor tablets in the
third quarter.
Progenics previously said FDA approval would trigger a $50
million milestone payment. Relistor was the first commercial
product for Tarrytown, N.Y.-based Progenics. In the first quarter,
Relistor royalty income of $2.2 million provided the bulk of
Progenics' $2.5 million of revenue.
In July, Guggenheim Securities said Progenics management
believed oral Relistor could be a $1 billion-plus opportunity for
Valeant.
In April, the FDA extended its evaluation of Relistor tablets by
three months to allow a full review of Valeant's responses to the
agency's requests for information.
Also on Tuesday, Valeant said an FDA advisory committee voted
unanimously to recommend approval for its psoriasis treatment
brodalumab.
In 2015, Valeant was hurt by a political backlash over drug
prices and concerns about the company's ties to mail-order pharmacy
Philidor Rx Services LLC. The company reduced its earnings guidance
in June, citing issues including sales-force turnover that slowed
sales growth for irritable-bowel drug Xifaxan.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
July 19, 2016 20:47 ET (00:47 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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