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.
