Actavis Confirms Generic Rayos® Patent Challenge

               Actavis Confirms Generic Rayos® Patent Challenge

PR Newswire

PARSIPPANY, N.J., Aug. 27, 2013

PARSIPPANY, N.J., Aug. 27, 2013 /PRNewswire/ --Actavis, Inc. (NYSE: ACT)
today confirmed that it has filed an Abbreviated New Drug Application (ANDA)
with the U.S. Food and Drug Administration (FDA) seeking approval to market
Prednisone Delayed-release Tablets, 1 mg, 2 mg and 5 mg. Actavis' ANDA
products are generic versions of Horizon Pharma's Rayos^®, which is approved
for use as an anti-inflammatory or immunosuppressive agent for certain
allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous
system, renal, respiratory, rheumatologic, specific infectious diseases or
conditions and organ transplantation; for the treatment of certain endocrine
conditions; and for palliation of certain neoplastic conditions.

Horizon Pharma AG and Jagotec AG filed suit against Actavis on August 26,
2013, in the U.S. District Court for the District of New Jersey seeking to
prevent Actavis from commercializing its ANDA products prior to the expiration
certain of U.S. patents. The lawsuit was filed under the provisions of the
Hatch-Waxman Act, resulting in a stay of finalFDAapproval of Actavis' ANDA
for up to 30 months from the date the plaintiffs received notice of Actavis'
ANDA filing or until final resolution of the matter before the court,
whichever occurs sooner, subject to any other exclusivities.

Based on available information, Actavis believes it may be a "first applicant"
to file an ANDA for the generic version of Rayos^® and, should its ANDA be
approved, may be entitled to 180 days of generic market exclusivity.

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical
company focused on developing, manufacturing and distributing generic, brand
and biosimilar products. Actavis has global headquarters in Parsippany, New
Jersey, USA.

Operating as Actavis Pharma, Actavis markets generic, branded generic, legacy
brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis
Specialty Brands is Actavis' global branded specialty pharmaceutical business
focused in the Urology and Women's Health therapeutic categories. Actavis
Specialty Brands also has a portfolio of five biosimilar products in
development in Women's Health and Oncology. Actavis Global Operations has
more than 30 manufacturing and distribution facilities around the world, and
includes Anda, Inc., a U.S. pharmaceutical product distributor.

For press release and other company information, visit Actavis' Web site at
http://www.actavis.com.

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 and outcome of the pending patent
litigation; 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; 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; and such other risks and
uncertainties detailed in Actavis' periodic public filings with the Securities
and Exchange Commission, including but not limited to Actavis' Quarterly
Report on Form 10-Q for the quarter ended June 30, 2013 and 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.

Rayos^® is a registered trademark of Horizon Pharma, Inc.

CONTACTS:

Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
Charlie Mayr
(862) 261-8030

(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )

SOURCE Actavis, Inc.

Website: http://www.actavis.com
 
Press spacebar to pause and continue. Press esc to stop.