Roche Introduces Program to Facilitate Corporate Pandemic Stockpiling of Tamiflu(R)

    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, 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 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
 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.
 
     About Tamiflu
 
     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
 www.rocheusa.com/products/tamiflu.
 
     About Roche
 
     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 www.RocheExchange.com.
 
 
 

SOURCE Roche

    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, 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 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
 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.
 
     About Tamiflu
 
     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
 www.rocheusa.com/products/tamiflu.
 
     About Roche
 
     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 www.RocheExchange.com.
 
 
 SOURCE Roche