Actavis Reaches Agreements with Valeant to Launch Generic Versions of Ziana® and Zyclara®

Actavis Reaches Agreements with Valeant to Launch Generic Versions of Ziana® 
and Zyclara® 
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 
immune function. 
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, 
Switzerland. 
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 
States. 
For press release and other company information, visit Actavis' Web site at 
http://www.actavis.com. 
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 
otherwise. 
Ziana(®) and Zyclara(®) are registered trademarks of Medicis Pharmaceutical 
Corporation. 
(Logo: http://photos.prnewswire.com/prnh/20101025/LA87217LOGO) 
Actavis:  Investors:  Lisa DeFrancesco  (862) 261-7152 
Media:  Charlie Mayr (862) 261-8030 
Valeant:  Laurie W. Little  (949) 461-6002 
http://www.valeant.com 
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO 
PRN Photo Desk, photodesk@prnewswire.com 
SOURCE: Valeant Pharmaceuticals International, Inc. 
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CO: Valeant Pharmaceuticals International, Inc.
NI: HEA MTC ORDER  
-0- Apr/10/2013 12:01 GMT
 
 
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