Actavis Reaches Agreements with Valeant to Launch Generic Versions of Ziana®
PARSIPPANY, N.J. and MONTREAL, April 10, 2013 /CNW/ - Actavis, Inc. (NYSE:
ACT), and Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX),
today announced that Actavis has reached settlement agreements with Medicis
Pharmaceutical Corporation, a subsidiary of Valeant Pharmaceuticals
International, Inc., resolving outstanding patent litigation related to
Actavis' Abbreviated New Drug Application (ANDA) for Clindamycin and Tretinoin
Gel, a generic version of Ziana(®), as well as Actavis' ANDA for Imiquimod
Cream, a generic version of Zyclara(®).
Under the terms of the agreement related to Actavis' generic version of
Ziana(®), Actavis may launch its generic product in July 2016, or earlier
under certain circumstances.
Under the terms of the agreement related to Actavis' generic version of
Zyclara(®), Actavis may launch its generic product on Jan. 1, 2019, or
earlier under certain circumstances.
Valeant will receive a share of the economics from the generic products sold
under the agreements. Other terms of the agreements have not been disclosed.
Ziana(®) is a lincosamide antibiotic and retinoid combination product
indicated for the topical treatment of acne vulgaris in patients 12 years or
older. Zyclara(®) is a prescription medicine for skin use only to treat
actinic keratosis on the full face or balding scalp in adults with a normal
About Actavis, Inc.
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical
company focused on developing, manufacturing and distributing generic, brand
and biosimilar products. The Company has global and U.S. headquarters in
Parsippany, New Jersey, USA, and international headquarters in Zug,
Actavis is the world's third-largest generics prescription drug manufacturer.
Operating as Actavis Pharma, the Company develops, manufactures and markets
generic, branded generic, legacy brands and Over-the-Counter (OTC) products in
more than 60 countries. The Company is ranked in the top 3 in 12 global
markets, the top 5 in 16 global markets, and in the top 10 in 33 global
markets. Actavis Pharma also develops and out-licenses generic pharmaceutical
products outside the U.S. through its Medis third-party business, a world
leading generic pharmaceutical out-licensing business. Medis has more than 300
customers globally, and offers a broad portfolio of more than 200 products.
Actavis Specialty Brands is the Company's global branded specialty
pharmaceutical business, which develops and markets a portfolio of
approximately 40 products principally in the United States and Canada that are
focused in the Urology and Women's Health therapeutic categories. Actavis
Specialty Brands is committed to developing and marketing biosimilars products
in Women's Health, Oncology and other therapeutic categories, and currently
has a portfolio of five biosimilar products in development.
Actavis Global Operations has more than 30 manufacturing and distribution
facilities around the world, with a capacity of approximately 44 billion units
annually. Actavis Global Operations also includes Anda, Inc., the
fourth-largest U.S. generic pharmaceutical product distributor in the United
For press release and other company information, visit Actavis' Web site at
About Valeant Pharmaceuticals International, Inc.
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,
neurology, and branded generics. More information about Valeant
Pharmaceuticals International, Inc. can be found at www.valeant.com.
Actavis Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts
are forward-looking statements that reflect Actavis' current perspective of
existing information as of the date of this release. It is important to note
that Actavis' goals and expectations are not predictions of actual
performance. Actual results may differ materially from Actavis' current
expectations depending upon a number of factors, risks and uncertainties
affecting Actavis' business. These factors include, among others, the
difficulty of predicting the timing or outcome of product development efforts,
including FDA and other regulatory agency approvals and actions, if any; the
impact of competitive products and pricing; the timing and success of product
launches; risks that resolution of patent infringement litigation through
settlement could result in investigations or actions by private parties or
government authorities or agencies; difficulties or delays in manufacturing;
the availability and pricing of third party sourced products and materials;
successful compliance with FDA and other governmental regulations applicable
to Actavis' and its third party manufacturers' facilities, products and/or
businesses; changes in the laws and regulations, including Medicare and
Medicaid, affecting among other things, pricing and reimbursement of
pharmaceutical products; and such other risks and uncertainties detailed in
Actavis' periodic public filings with the Securities and Exchange Commission,
including but not limited to Actavis' Annual Report on Form 10-K for the year
ended December 31, 2012. Except as expressly required by law, Actavis
disclaims any intent or obligation to update these forward-looking statements.
Valeant Forward-Looking Statement
This press release contains forward-looking statements regarding, among other
things, the Valeant's expectation to share in the economics of generic product
sales under the settlement agreement. Statements including words such as
"believes," "expects," "anticipates," "intends," "estimates," "plan," "will,"
"may," "intend," "guidance" or similar expressions are forward-looking
statements. Because these statements reflect Valeant's current views,
expectations and beliefs concerning future events, these forward-looking
statements involve risks and uncertainties. Investors should note that many
factors could cause actual results to differ materially from those expressed
in forward-looking statements contained in this press release. These factors
include, but are not limited to risks and uncertainties detailed from time to
time in Valeant's periodic reports filed with the Securities and Exchange
Commission ("SEC") and the Canadian Securities Administrators ("CSA"),
including current reports on Form 8-K, quarterly reports on Form 10-Q and
annual report on Form 10-K, particularly the discussion under the caption
"RISK FACTORS" in Valeant's annual report on Form 10-K for the year ended
December 31, 2012, which have been filed with the SEC and the CSA. The
forward-looking statements in this press release are qualified by these risk
factors. These are factors that, individually or in the aggregate, could cause
Valeant's actual results to differ materially from expected and historical
results. Valeant assumes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future developments or
Ziana(®) and Zyclara(®) are registered trademarks of Medicis Pharmaceutical
Actavis: Investors: Lisa DeFrancesco (862) 261-7152
Media: Charlie Mayr (862) 261-8030
Valeant: Laurie W. Little (949) 461-6002
PRN Photo Desk, firstname.lastname@example.org
SOURCE: Valeant Pharmaceuticals International, Inc.
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