MORRISTOWN, N.J., Sept. 17 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today confirmed that Actavis Elizabeth L.L.C. has initiated a challenge of the patent listed in connection with King Pharmaceuticals’ Avinza(R) (morphine sulfate extended-release capsules). Actavis believes that it is the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avinza.
Actavis filed its ANDA for Avinza containing the paragraph IV certification with the U.S. Food and Drug Administration (FDA) in June 2007. Upon receiving filing acceptance from the FDA, Actavis Elizabeth LLC notified King Pharmaceuticals and the patent owner. On 10 September, 2007, King issued a press release that confirmed that it received Actavis Elizabeth’s paragraph IV certification notice and that it intends to enforce its patent.
Avinza(R) capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. The product had annual sales of approximately US$169 million for a 12 month period, ending June 2007, according to IMS Health data.
About Actavis
Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in 39 countries, with 11,000 employees. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company’s single largest market. In the U.S. alone, the company made 38 ANDA filings in 2006 and expects to file 40-45 in the year 2007 along with 18-20 new product launches. The company’s U.S. operations are located in New Jersey, Maryland, North Carolina and Florida.
More information about Actavis in the United States can be found at www.actavis.us.
Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.
Actavis Group
CONTACT: David Myers, Jr., Manager, Products & Communications in theUnited States, +1-973-993-4503, dmyers@actavis.com, or HalldorKristmannsson, Vice President of Corporate Communications, +354-535-2325 or+354-840-3425, hkristmannsson@actavis.com, both of Actavis
Web site: http://www.actavis.us/
