NUTLEY, N.J., May 8 /PRNewswire/ -- In an effort to ensure patients receive only authentic Tamiflu(R) (oseltamivir phosphate) antiviral medication, Roche has released practical guidelines outlining a number of steps consumers can take to protect themselves, along with a compilation of information resources and web links. The new recommendations can be viewed at http://www.tamiflu.com/. Tamiflu, the leading prescription antiviral medication for prevention and treatment of influenza, is the only oral antiviral that has shown activity in vitro and in animal studies against the H5N1 strain of the avian flu virus, which is spreading throughout regions of Asia, the Middle East, Africa and Europe. "Consumers worldwide can be assured that Roche is doing everything possible to protect the integrity of Tamiflu, and indeed all its products," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc. "We take the counterfeiting threat extremely seriously, and continually adapt our procedures. Diminishing the threat, of course, requires active cooperation of all parties involved -- regulatory and law enforcement, manufacturers, distributors, retailers, and ultimately consumers." Abercrombie added that by knowing what to look for, consumers can play a valuable role in protecting themselves from the risks posed by counterfeit drugs. The new guidelines from Roche provide specific information and tools to help consumers avoid purchasing counterfeit Tamiflu, identify valid product, and act judiciously if suspicions arise. Recommendations include: * How to Avoid Purchasing Counterfeit Drugs -- Consumers should use caution when purchasing on the Internet, be wary of offers to sell medications without a valid prescription, and only purchase from a licensed pharmacy. * How to Identify Authentic Tamiflu vs. "Copycats" -- Tamiflu comes in a white cardboard box, which contains a single blister package with 10 capsules. Each capsule is a distinctive yellow and light grey color, and printed with the words "Roche 75mg". * Where to obtain information related to counterfeiting -- Identifying licensed pharmacies, obtaining counterfeit drug alerts, reporting suspicious product or retailers to the proper authorities. Additional details, including product photos, are included in the guidelines at http://www.tamiflu.com/ "FAQ/Resources" http://www.tamiflu.com/consumer_guidelines.asp. The guidelines will also be distributed through additional channels, such as professional and patient advocacy groups. Latest in Series of Corporate Initiatives The consumer guidelines are the latest element in Roche's corporate anti-counterfeiting initiative, which includes Internet surveillance, communications protocols and tracking systems. The tactics are designed to protect the integrity of Tamiflu from criminal counterfeiting, particularly in light of recent seizures of counterfeit shipments in the U.S. and abroad. Roche actively works with both U.S. and global regulatory agencies such as the U.S. Food & Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA); global health authorities such as the WHO; law enforcement agencies such as the Interpol; and customs, policy and trade organizations at local levels. "While many of the anti-counterfeit activities cannot be disclosed for security reasons, Roche continues to proactively protect the integrity of Tamiflu throughout the supply chain by ensuring the product is distributed only through legitimate channels," explained Abercrombie. Meanwhile, Roche continues to work with governments and health authorities such as the Centers for Disease Prevention and Control (CDC) and the World Health Organization (WHO) to develop stockpiles and make sure Tamiflu is available to those who need it. Roche has increased annual production capacity for Tamiflu to 400 million treatment courses. About Tamiflu Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have been symptomatic for no more than two days. Tamiflu is also indicated for the prophylaxis of influenza in patients one year and older. In treatment studies in adult patients, the most frequently reported adverse events (incidence >1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence >1%) was vomiting. Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis. In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence >1%) were nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients one to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed. Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied. In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Vaccination is considered the first line of defense against influenza. Tamiflu is available for the treatment of influenza in more than 80 countries worldwide. About Roche Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com/ or http://www.roche.us/. DATASOURCE: Roche CONTACT: Terence Hurley, of Roche, +1-973-562-2882, ; or Sue Preziotti, of Fleishman-Hillard, +1-212-453-2144, , for Roche Web site: http://www.rocheusa.com/ http://www.roche.us/ http://www.tamiflu.com/

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