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 /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, 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.
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.
SOURCE Actavis, Inc.