Orexigen in Canadian Marketing Pact With Valeant for Diet Drug
August 30 2016 - 10:15AM
Dow Jones News
By Anne Steele
Orexigen Therapeutics Inc. (OREX) on Tuesday said it tapped
Valeant Pharmaceuticals International Inc.'s (VRX) Canada
subsidiary to help it win regulatory approval for its controversial
obesity drug in Canada and commercialize it there.
Terms of the agreement weren't disclosed. Orexigen shares shot
up 14% premarket to $4.35, while Valeant shares slipped 0.8% to
$30.
In the deal, Valeant will be responsible for obtaining Canadian
regulatory approval as well as all expenses. Orexigen will supply
Contrave tablets to Valeant Canada for an agreed transfer price and
potential regulatory and sales milestone payments. Orexigen said it
expects Valeant to file for regulatory approval by January.
The Orexigen drug has had a bumpy ride. In 2011, the U.S. Food
and Drug Administration declined to approve Contrave over concerns
that patient pulse rates and blood pressure rose. Orexigen was then
required to start a 10,000-patient outcomes study to assess
cardiovascular risks before the FDA would consider approval, which
finally came in 2014. It was the third in a trio of diet drugs that
were approved in the U.S., following a decade in which other diet
pills were withdrawn because of safety concerns and no new
medicines were endorsed by the FDA.
On Tuesday, Orexigen pointed to recent data from Statistics
Canada, which indicate almost two-thirds of Canadian adults are now
either overweight or obese.
Orexigen and Valeant in March announced a commercialization
agreement for Mysimba--the weight loss drug's name outside the
U.S.--in 19 countries in Central and Eastern Europe. The companies
anticipate launching Mysimba in 11 countries in the fourth quarter
and two additional countries in the first quarter of 2017.
Write to Anne Steele at anne.steele@wsj.com
(END) Dow Jones Newswires
August 30, 2016 10:00 ET (14:00 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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