US and EU regulatory submission planned in moderate-to-severe
psoriasis in Q4 2015
LAVAL, Quebec, Sept. 1, 2015 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced that its affiliate has entered into a collaboration
agreement with AstraZeneca under which Valeant was granted an
exclusive license to develop and commercialize brodalumab.
Brodalumab is an IL-17 receptor monoclonal antibody in
development for patients with moderate-to-severe plaque psoriasis
and psoriatic arthritis. Under the agreement, Valeant will hold the
exclusive rights to develop and commercialize brodalumab globally,
except in Japan and certain other
Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd
under a prior arrangement with Amgen Inc., the originator of
brodalumab. Valeant will assume all development costs associated
with the regulatory approval for brodalumab. Regulatory submission
in US and EU for brodalumab in moderate-to-severe psoriasis is
planned for the fourth quarter of 2015.
Under the terms of the agreement, Valeant will make an up-front
payment to AstraZeneca of $100
million, as well as additional pre-launch milestones of up
to $170 million and further
sales-related milestone payments of up to $175 million following launch. After approval,
AstraZeneca and Valeant will share profits.
Brodalumab is supported by data from the three AMAGINE Phase III
pivotal studies. The results highlighted that brodalumab has an
effective mechanism of action that delivers clinical benefit and
could help a significant number of moderate-to-severe plaque
psoriasis patients achieve total clearance of their skin disease.
At the 210 mg dose, brodalumab was shown to be efficacious in total
skin clearance of psoriasis compared to placebo and superior to
ustekinumab at week 12 in two replicate comparator trials involving
over 3,500 patients.
Pascal Soriot, Chief Executive Officer of AstraZeneca, said:
"Our agreement will help to bring brodalumab to patients with
psoriasis who need new treatment options through Valeant's expert
focus on dermatology."
J. Michael Pearson, Chairman and
Chief Executive Officer of Valeant, said, "We are delighted we were
able to reach a licensing agreement with AstraZeneca to
commercialize brodalumab, which is potentially the most efficacious
therapy yet for moderate-to-severe plaque psoriasis. We remain
fully committed to dermatology and will continue to advance our
pipeline of internally developed and acquired products."
The transaction is expected to complete in the fourth quarter of
2015, subject to customary closing conditions, including
Hart-Scott-Rodino anti-trust clearance.
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 IL-17 ligands to the receptor. By stopping IL-17
ligands 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.
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 disorder, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
About AstraZeneca
AstraZeneca is a global,
innovation-driven biopharmaceutical business that focuses on the
discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology,
infection and neuroscience diseases. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit:
www.astrazeneca.com.
Forward-looking Statements
This press release may contain forward-looking statements,
including, but not limited to, statements regarding the closing of
the transaction (including the timing of closing), the aggregate
amount investment to be paid by Valeant, the anticipated timing of
regulatory submissions, the anticipated benefits of brodalumab, and
the advancement of Valeant's pipeline. 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 of management of Valeant 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 (the "SEC") 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.
Contact
Information:
Laurie W. Little
949-461-6002
laurie.little@valeant.com
Media:
Renee E. Soto/Meghan Gavigan
Sard Verbinnen & Co.
212-687-8080
rsoto@sardverb.com / mgavigan@sardverb.com
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SOURCE Valeant Pharmaceuticals International, Inc.