- Offers Businesses New Flexibility for Pandemic Planning -
NUTLEY, N.J., June 26 /PRNewswire/ -- Roche announced today the introduction of a flexible purchase program that will allow U.S. businesses to maintain access to their own stockpile of Tamiflu(R) for use in a pandemic situation, with limited upfront investment and more adaptability to deal with unknown factors inherent in pandemic planning.
Under the new plan, businesses pay a nominal annual fee to "reserve" their own stockpile of Tamiflu, which Roche will store and rotate to keep "in date." The contract comes up for renewal annually, at which time companies will have the opportunity to re-evaluate their investment decision. If and when a company decides to take possession of the medicine - for example, if a novel strain of influenza virus begins human-to-human spread - they can purchase their dedicated product from Roche at the prevailing wholesale price. Roche will guarantee delivery within 48 hours in most circumstances.
"This program addresses questions we've heard from executives, who are interested in securing Tamiflu for their employees, but desire more flexible planning options, especially with regard to timing," said Mike McGuire, vice president of anti-infectives for Roche. "We think this option will present something of a 'tipping point' for some companies, allowing them to create the best possible situation for the health of their business as well as their employees."
Businesses can still purchase Tamiflu outright and consider pre- distribution to their employees, which is what some corporations have preferred.
"Roche continues to work with the U.S. Department of Health & Human Services (HHS) to aid the stockpiling of antivirals by businesses," said George Abercrombie, CEO and president of Hoffmann-La Roche Inc. "This new program greatly facilitates corporate antiviral stockpiling and clearly demonstrates Roche's long-standing commitment to creating solutions that will help our country meet its pandemic preparedness goals."
Role of Corporations in Pandemic Preparedness & Response
In its original National Strategy for Pandemic Influenza, which was issued in November 2005, the federal government noted that the private sector "should play an integral role in preparedness before a pandemic begins, and should be part of the national response."
HHS took it a step further on the department's pandemic preparedness web site, http://www.pandemicflu.gov, indicating that: "In the event of pandemic influenza, businesses and other employers will play a key role in protecting employees' health and safety as well as limiting the negative impact to the economy and society."
On June 3, 2008, the U.S. government released proposed guidances for businesses on the stockpiling of antiviral medications as part of pandemic flu planning. The guidances, which are posted at http://www.pandemicflu.gov for public comment, state: "Private stockpiles, in coordination with public health stockpiles, would extend protection more broadly than could be achieved through the public sector alone and improve the ability to achieve the national pandemic response goals of mitigating disease, suffering, and death, and minimizing impacts on the economy and functioning of society."
Antivirals Key Line of Defense
If and when a pandemic strikes, antivirals will be a key line of defense until a vaccine can be developed and distributed. According to the draft government guidance released on June 3, "once the pandemic strain emerges and is identified, based on current technologies, it will take at least 20 weeks [five months] before the first doses of a pandemic vaccine are available ... By contrast, antiviral drugs can be stockpiled in advance and therefore be available when a pandemic begins."
"Experience with seasonal flu has shown that antiviral drugs are an important tool in the arsenal of weapons that could be used to help contain a flu pandemic," said Health and Human Services Deputy Secretary Tevi Troy. "They may play a critical role in the earliest pandemic stages, by helping contain an early outbreak wherever it occurs, slowing the spread of the disease, and treating those who are ill during later community outbreaks."
The Strategic National Stockpile of antiviral medications will only cover 25% of the population. Moreover, if antivirals are used preventatively, as the World Health Organization (WHO) recommends, additional supplies would be needed.
Antivirals such as Tamiflu are most effective if taken early, within 48 hours of illness onset. The WHO currently has regional stockpiles in place and administers the antiviral drugs to patients as part of its Rapid Response Protocol for human cases of H5N1 avian influenza virus.
"Roche supports the public health community in its goal to distribute as much medicine as possible before a pandemic outbreak," explains McGuire. "Once an outbreak occurs or a pandemic flu starts spreading, it will be impossible to meet immediate and widespread demand for Tamiflu."
"Stockpiling of antivirals is an essential act of preparedness for a potential flu pandemic, but it is one that is a shared responsibility that extends across all levels of government and all segments of society," Deputy Secretary Troy said. "Planning efforts by business and private industry, such as this new Roche stockpiling program, comprise a fundamental part of our nation's efforts to ensure community resilience in a public health emergency. We encourage government, private industry and individuals to take action to prepare."
Roche is a Committed Partner and Resource for Pandemic Preparedness
The introduction of the new corporate purchase program is the most recent effort by Roche in its collaboration with businesses and multiple levels of government to make Tamiflu more available and accessible to those who may need it in a pandemic. Roche increased global production of Tamiflu more than 15- fold and created a complete supply chain on U.S. soil at the request of HHS. The company has donated more than 5 million treatment courses to the WHO for use as a rapid response at the site of a pandemic outbreak and for its regional stockpiles.
Roche has also sponsored a series of pandemic planning workshops for businesses around the country, creating a forum for multi-sector dialogue. Insights, information and practical tools have been compiled by Roche at http://www.pandemictoolkit.com.
Roche has taken extensive steps to ensure its own business continuity and continued manufacturing of Tamiflu and other life-saving medicines during a pandemic outbreak. Roche has provided Tamiflu to all its employees in the U.S. and globally, along with medical consultation and education about disease prevention and pandemic flu.
To date, Roche U.S. has received inquiries from more than 800 U.S.-based companies, large and small in a variety of industries, with Tamiflu orders from more than 300 companies, in quantities ranging from a few hundred to hundreds of thousands of treatment courses.
For more information, businesses may contact Roche via phone: Pandemic Planning Hotline 888-394-2838, or by e-mail: Nutley.TAMIFLU_Inquiry@Roche.com.
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have had flu symptoms for no more than two days. Tamiflu is also indicated for the prevention of influenza in patients one year and older. Tamiflu is not a substitute for annual early vaccination as recommended by the CDC.
Tamiflu was approved based on studies in seasonal influenza. The magnitude of effect of Tamiflu in treating and preventing novel strains of influenza (such as those that may be involved in a pandemic or associated with avian flu) cannot be predicted.
In post-marketing experience, rare cases of anaphylaxis and serious skin reactions have been reported. There have been post-marketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. The reports were primarily among children. The relative contribution of the drug to these events is not known. Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period.
The most frequently reported adverse events in clinical studies were nausea, vomiting, and diarrhea.
Tamiflu is available for the treatment of influenza in more than 80 countries worldwide. Prescribing information for Tamiflu is available at http://www.rocheusa.com/products/tamiflu.
Hoffmann-La Roche Inc. (Roche), in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, a leading, global healthcare company. For more than 100 years, Roche has been developing innovative products and services that address prevention, diagnosis and treatment of disease. For more information, visit http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at http://www.RocheExchange.com.
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