NUTLEY, N.J., Nov. 1 /PRNewswire/ -- Roche announced that it is prepared to supply its antiviral medication Tamiflu(R) (oseltamivir phosphate) for the Strategic National Stockpile, following President Bush’s remarks at the National Institutes of Health (NIH) today. The company said it will work with the U.S. Department of Health and Human Services (HHS) to coordinate a delivery schedule based on the number of treatments ordered.
“Roche continues to take all necessary steps in order to help protect the public health on a worldwide basis by making Tamiflu available for pandemic stockpiling. We are working in conjunction with our manufacturing partners to do our part in ensuring preparedness in the U.S.,” said George B. Abercrombie, President and CEO, Hoffmann-La Roche Inc. “Over the past three years, Roche has invested significantly in pandemic planning for influenza. We have taken a number of major steps to increase the global production and availability of Tamiflu, and are also in contact with companies that may be able to assist in manufacturing additional supplies of Tamiflu.”
Roche has an internal high-level team in place that is dedicated to assessing the ability of other companies and partners to either produce or provide capabilities in Tamiflu production. Roche wants to be sure that potential partners can produce substantial incremental amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety and regulatory guidelines.
Global Production Capacity
Following discussions with HHS in 2003, Roche began to expand its Tamiflu supply chain. The U.S. Food and Drug Administration (FDA) recently approved an additional manufacturing site in the U.S. for the production of Tamiflu. The newly registered site in the U.S. further expands Roche’s already significantly increased worldwide production capacity.
This U.S. facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third-party manufacturers. By mid-2006, global production capacity for Tamiflu will have increased eight to ten-fold over 2003. Roche has already fulfilled an initial U.S. government request and delivered 2.3 million Tamiflu treatment courses in 2004 and is on schedule to deliver another two million treatments as ordered for 2005.
Increased Manufacturing Capacity
Roche began increasing its Tamiflu production capacity in 2003, when the threat of avian flu began to escalate. Since that time, Roche has taken the following steps, at its own investment, to prepare for and facilitate stockpiling needs:
-- Doubled its production capacity for Tamiflu in 2004 and 2005; -- Committed to increase manufacturing capacity eight to ten-fold by mid- 2006 (over 2003); -- Received FDA approval for an additional manufacturing facility; -- Developed special U.S. packaging for federal government for stockpiled Tamiflu in order to allow extension of expiration dating and ease distribution and administration in the event of a pandemic; and -- Developed a synthetic process for manufacturing the chemical used in the initial production step, which will ultimately greatly reduce reliance on natural sources; -- Committed to a single discounted global pandemic price for all industrialized nations. Tamiflu Donation to the WHO
Roche recently donated three million treatment courses of Tamiflu to the World Health Organization (WHO) for use in an influenza pandemic, primarily at the site of a potential outbreak of human influenza. This would help establish a rapid response stockpile of Tamiflu to contain or delay the spread of virus at the source of a pandemic. Roche continues to work closely with global health experts, governments and the WHO to ensure Tamiflu availability for pandemic stockpiling needs.
Role of Tamiflu in Pandemic Planning
Both the Infectious Diseases Society of America (IDSA) and the WHO have acknowledged that Tamiflu, the only oral antiviral medication proven effective against the H5N1 influenza strain, is uniquely suited to pandemic stockpiling, because of:
1) its efficacy against influenza types A and B; 2) the product’s five-year shelf life; and 3) minimal known Tamiflu-resistant virus in humans.
The WHO advises that governments order enough Tamiflu to cover between 20 to 40 percent of their population. Roche has received and is filling - on schedule - pandemic stockpile orders for Tamiflu from approximately 40 countries worldwide.
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). The leading prescription oral antiviral drug, Tamiflu is indicated for treatment of type A and B influenza in patients one year and older. Tamiflu is an effective treatment, and can reduce the duration and severity of the flu when taken within two days of symptom onset. Tamiflu, a neuraminidase inhibitor, works by attacking the influenza virus and its ability to replicate, rather than simply addressing influenza symptoms.
Tamiflu is also approved for the prevention of influenza in adults and adolescents 13 years and older. Clinical trials have shown Tamiflu is effective in preventing influenza illness when taken once daily for at least seven days. For the prevention of influenza in those 13 years or older, Tamiflu is administered following close contact with an infected individual who demonstrates characteristic symptoms of influenza, and based on knowledge that influenza is circulating in the area for 10 days, or up to six weeks for seasonal prophylaxis.
Tamiflu is generally well tolerated. In treatment studies in adults, the most frequently reported adverse events were mild-to-moderate transient nausea and vomiting. Other events reported more frequently than with placebo were bronchitis, insomnia and vertigo. In prophylaxis studies in patients aged 13 and older, adverse events were qualitatively similar to those seen in the treatment studies despite a longer duration of dosing. Events reported more frequently in subjects receiving Tamiflu compared to subjects receiving placebo in prophylaxis studies included nausea, vomiting, diarrhea, abdominal pain, dizziness, insomnia, headache, vertigo and fatigue.
In pediatric treatment studies, the most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric patients treated with Tamiflu included abdominal pain, epistaxis, ear disorder and conjunctivitis. These events generally occurred once and resolved despite continued dosing.
Efficacy of Tamiflu in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established.
Tamiflu was approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated acute illness due to influenza infection in adults in October 1999. The FDA granted marketing approval for the prevention of naturally occurring influenza A and B in adults and adolescents 13 years and older in November 2000. The FDA granted marketing approval of the oral suspension for use in the treatment of influenza A and B in children one year and older in December 2000. Tamiflu oral suspension is used for pediatric patients one year and older or adult patients who cannot swallow a capsule. Tamiflu is the first and only liquid suspension to treat influenza A and B. Vaccination is considered the first line of defense against influenza. Tamiflu is available for the treatment of influenza in more than 40 countries worldwide. For more information visit www.Tamiflu.com
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world’s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche’s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche’s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, visit the worldwide and U.S. websites (Global: www.roche.com and U.S.: www.roche.us).
Roche
CONTACT: Terence Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com; or Sue Preziotti of Fleishman-Hillard,+1-212-453- 2144, preziots@fleishman.com, for Roche
