Valeant Receives Upfront Payment & Milestone Payments
from AstraZeneca In Exchange for Termination of European Rights to
Brodalumab
LAVAL, Quebec, July 1, 2016 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX:VRX)
("Valeant") today announced that its affiliate and AstraZeneca
(LSE/SSE/NYSE: AZN) have amended Valeant's license for
brodalumab, an IL-17 receptor monoclonal antibody under regulatory
review for patients with moderate-to-severe plaque psoriasis, to
terminate Valeant's right to develop and commercialize brodalumab
in Europe.
In August 2015, AstraZeneca and
Valeant entered into an agreement granting Valeant an
exclusive license to develop and commercialize brodalumab globally,
other than in Japan and certain
other Asian countries. Under the terms of the amended
agreement, Valeant will continue to hold the license to develop and
commercialize brodalumab in the U.S, as well as the remainder of
the territory outside of Europe.
As consideration for the termination of the European rights,
AstraZeneca will pay to Valeant an upfront payment and certain
sales-based milestone payments and, in addition, one of the
pre-launch milestones payable by Valeant to AstraZeneca under the
original license has been reduced.
With the termination of Valeant's licensing rights to brodalumab
in Europe, AstraZeneca has entered
into an agreement granting LEO Pharma the exclusive rights to
develop and commercialize brodalumab in Europe.
On January 25, 2016, Valeant
announced that the U.S. Food and Drug Administration (FDA) had
accepted for review the Biologics License Application (BLA)
submitted by AstraZeneca in partnership with Valeant for brodalumab
injection for the treatment of moderate-to-severe plaque psoriasis
and assigned a Prescription Drug User Fee Act (PDUFA) action date
of November 16, 2016. In addition,
the Dermatologic and Ophthalmic Drugs Advisory Committee will
review Valeant's BLA on July 19,
2016.
"We are pleased with this new licensing arrangement for
brodalumab, which enables us to more sharply focus our efforts on
delivering this important treatment to patients in the U.S. and
other key markets, while providing us with immediate value and
significant ongoing exposure to the treatment's commercialization
in Europe," said Joseph C. Papa, chairman and chief executive
officer of Valeant. "Our current focus is on the upcoming
advisory panel, where we will have the opportunity to discuss
brodalumab treatment options for adult patients with moderate to
severe plaque psoriasis and provide information about this novel
antibody we are developing."
About brodalumab
Brodalumab is a novel human monoclonal antibody that binds to
the interleukin-17 (IL-17) receptor and inhibits inflammatory
signaling by blocking the binding of several types of IL-17 to the
receptor. By stopping IL-17 from activating the receptor,
brodalumab prevents the body from receiving signals that may lead
to inflammation. The IL-17 pathway plays a central role in inducing
and promoting inflammatory disease processes.
Safety Information
The most common adverse reactions in the clinical studies were
headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea.
Suicidal ideation and behavior and serious infections have been
reported in the studies.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, gastrointestinal disorders,
eye health, neurology and branded generics. More information about
Valeant can be found at www.valeant.com.
Forward-looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements respecting the timing of
the review of Valeant's BLA for brodalumab by the Dermatologic and
Ophthalmic Drugs Advisory Committee, the timing and likelihood of
the approval of such BLA and the anticipated benefits of
brodalumab. Forward-looking statements may generally be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include the risks and uncertainties
discussed in Valeant's most recent annual or quarterly report and
detailed from time to time in Valeant's other filings with
the Securities and Exchange Commission and the Canadian
Securities Administrators, which factors are incorporated herein by
reference. Readers are cautioned not to place undue reliance on any
of these forward-looking statements. These forward-looking
statements speak only as of the date hereof. Valeant undertakes no
obligation to update any of these forward-looking statements to
reflect events or circumstances after the date of this press
release or to reflect actual outcomes, unless required by law.
Contact Information:
Laurie W.
Little
laurie.little@valeant.com
or
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
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SOURCE Valeant Pharmaceuticals International, Inc.