Actavis Reaches Agreement with AstraZeneca to Launch a Generic Version of
Crestor® in 2016
- Launch to occur 67 days ahead of expiry of pediatric exclusivity -
PARSIPPANY, N.J., March 25, 2013
PARSIPPANY, N.J., March 25, 2013 /PRNewswire/ --Actavis, Inc. (NYSE: ACT), a
leading specialty pharmaceutical company, today announced that is has reached
a settlement agreement with AstraZeneca resolving outstanding patent
litigation related to Actavis' generic version of rosuvastatin calcium 5, 10,
20 and 40 mg tablets, the generic version of Crestor^® tablets, as well as
Actavis' rosuvastatin zinc alternate salt product.
Under the terms of the agreement, Actavis can launch its generic version of
Crestor^® 67 days prior to July 8, 2016, the expiration of pediatric
exclusivity, at a fee of 39% of net sales to AstraZeneca. The entry date may
be earlier, and the fee eliminated, under certain circumstances. Egis
Pharmaceuticals, Actavis' partner, will also benefit from sales of the
product. Launch of Actavis' product is contingent upon the Company receiving
final approval from the U.S. Food and Drug Administration (FDA) on its
Abbreviated New Drug Application (ANDA) for generic Crestor^®. The FDA
granted tentative approval to Actavis' ANDA on June 6, 2011.
As part of the agreement, Actavis is permitted to launch its rosuvastatin zinc
alternate salt product beginning May 2, 2016 or earlier under certain
circumstances, however, at this time, the company has made no decision
regarding a potential launch. Actavis' rosuvastatin zinc alternate salt
product previously received tentative approval from the FDA in August 2011 but
would not be generically substitutable for Crestor^® and would have required
Actavis to convert patients from rosuvastatin calcium. Other details of the
settlement are confidential.
"This agreement ensures that consumers will benefit from an earlier launch of
a rosuvastatin calcium product and eliminates ongoing litigation and
uncertainty of marketplace acceptance of a non-generically substitutable
product if Actavis had proceeded to launch the alternate product," said Paul
Bisaro, President and CEO of Actavis, Inc.
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
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.
Crestor® is a trademark of AstraZeneca.
(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )
SOURCE Actavis, Inc.
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