Actavis Comments on Notification to Allergan, Inc. of Submission of Application for Restasis®
DUBLIN, Jan. 22, 2014 /PRNewswire/ — Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Allergan, Inc.’s Restasis(®) (cyclosporine ophthalmic emulsion) 0.05% product.
Actavis’ ANDA was submitted prior to the issuance of FDA guidance related to approval of generic versions of Restasis(®) products. Following issuance of FDA guidance in June 2013, FDA notified Actavis’ subsidiary that it had refused to receive the ANDA for filing. Actavis disagrees with FDA’s refusal to receive its ANDA for filing and remains in discussions with FDA concerning the filing status of its application.
On January 14, 2014, the U.S. Patent and Trademark Office issued a patent claiming a method of use related to Restasis(®). In accordance with applicable rules, Actavis’ subsidiary amended its ANDA on that date to include a Paragraph IV certification to the newly issued patent and, in order to preserve its potential first-filer status, notified Allergan of its Paragraph IV certification. Actavis continues to work with the FDA to clarify the filing status of its ANDA.
Restasis(®) is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation.
Actavis plc (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 Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.
Actavis Pharma markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is a global branded specialty pharmaceutical business focused principally in the Urology and Women’s Health therapeutic categories, as well as Gastroenterology and Dermatology. 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.
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 whether the FDA will accept Actavis’ generic Restasis® ANDA for filing or, if accepted by FDA, the date on which FDA will deem the application filed; the difficulty of predicting the timing or outcome of potential patent litigation concerning Actavis’ ANDA for a generic version of Restasis®; 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; the difficulty of predicting how the FDA will interpret applicable Hatch Waxman rules related to Actavis’ entitlement to marketing exclusivity and the possibility that an adverse interpretation of such rules could negatively affect Actavis’ marketing exclusivity; 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’ quarterly report on form 10-Q for the quarter ended September 30, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
CONTACTS: Investors: Lisa DeFrancesco (862) 261-7152 Media: Charlie Mayr (862) 261-8030 David Belian (862) 261-8141
SOURCE Actavis plc