MORRISTOWN, N.J., Sept. 17 Actavis Group, theinternational generic pharmaceuticals company, today confirmed that ActavisElizabeth L.L.C. has initiated a challenge of the patent listed in connectionwith King Pharmaceuticals' Avinza(R) (morphine sulfate extended-releasecapsules). Actavis believes that it is the first company to file anAbbreviated New Drug Application (ANDA) containing a paragraph IVcertification for Avinza.
Actavis filed its ANDA for Avinza containing the paragraph IVcertification with the U.S. Food and Drug Administration (FDA) in June 2007.Upon receiving filing acceptance from the FDA, Actavis Elizabeth LLC notifiedKing Pharmaceuticals and the patent owner. On 10 September, 2007, King issueda press release that confirmed that it received Actavis Elizabeth's paragraphIV certification notice and that it intends to enforce its patent.
Avinza(R) capsules are a modified-release formulation of morphine sulfateintended for once daily administration indicated for the relief of moderate tosevere pain requiring continuous, around-the-clock opioid therapy for anextended period of time. The product had annual sales of approximately US$169million for a 12 month period, ending June 2007, according to IMS Health data.
Actavis is one of the world's leading generic pharmaceutical companiesspecializing in the development, manufacture and sale of genericpharmaceuticals. With headquarters in Iceland, Actavis has operations in 39countries, with 11,000 employees. Actavis expects 2007 sales to total EUR1.6bn,with approximately one-third of these sales coming from the United States, thecompany's single largest market. In the U.S. alone, the company made 38 ANDAfilings in 2006 and expects to file 40-45 in the year 2007 along with 18-20new 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 atwww.actavis.us.
Information in this press release may contain forward-looking statementswith respect to the financial condition, results of operations and businessesof Actavis. By their nature, forward-looking statements and forecasts involverisk and uncertainty because they relate to events and depend on circumstancesthat will occur in the future. There are a number of factors that could causeactual results and developments to differ materially from that expressed orimplied by these forward-looking statements. These factors include, amongother things, exchange rate fluctuations, the risk that research anddevelopment will not yield new products that achieve commercial success, theimpact of competition, price controls and price reductions, the risk of lossor expiration of patents or trade marks, difficulties of obtaining andmaintaining governmental approvals for products, the risk of substantialproduct liability claims, exposure to environmental liability.
SOURCE Actavis Group