Roche announced today that its prescription antiviral medication Tamiflu(R) (oseltamivir phosphate) will be in ample supply during the 2006-2007 flu season in pharmacies across the
U.S., with more than double the stock available last season. Tamiflu is
indicated for the treatment and prevention of influenza in adults and in
children 1 year and older.
"During the past year, Roche has continued to take all necessary steps
to ensure that Tamiflu is available for pandemic preparedness as well as
seasonal flu, in keeping with the recommendations of public health
officials and the needs of our customers," said George Abercrombie,
President and CEO, Hoffmann- La Roche Inc. "Physicians can be confident
that Tamiflu will be readily and widely available to patients who need it
for flu treatment and post-exposure prevention."
While Tamiflu has been widely associated with pandemic preparedness, it
was developed for seasonal flu prophylaxis and treatment. Roche has a
proactive inventory management plan in place that is designed to ensure
that Tamiflu is available to patients when and where it is needed.
According to recommendations issued in June by the U.S. Centers for
Disease Control and Prevention, oseltamivir (Tamiflu) and zanamivir
(Relenza) should be prescribed if an antiviral medication is needed for
seasonal flu treatment or prophylaxis.(1) Due to high levels of resistance,
CDC recommends against the use of two other antiviral agents, amantadine
and rimantadine, until susceptibility of these agents has been
re-established among circulating influenza A viruses.(2)
Influenza is a serious illness that affects up to 40 million Americans
every year, causing disruption to their daily lives, and leading to 200,000
hospitalizations and 36,000 deaths annually.(3) In a typical year, it is
estimated that influenza may result in as much as $10 billion in lost
productivity.(4)
While vaccine is the first line of defense against seasonal influenza,
prescription antiviral medications like Tamiflu play an important role in
prevention and treatment of influenza. Prophylactic use of antivirals is
recommended by the CDC for people at high-risk of influenza as well as
health care workers and institutional settings, such as nursing homes.(5)
How Tamiflu Works
Tamiflu belongs to a class of antiviral medicines called neuraminidase
inhibitors (NAI), which help prevent the flu virus from spreading inside
the body. Virtually all common flu viruses have the neuraminidase protein
on their surface, which enables them to migrate from cell to cell,
replicating and spreading throughout the body. Inhibiting the neuraminidase
activity is believed to interfere with this process, possibly causing the
viruses to become trapped and die out. Tamiflu is given orally and is
systemically absorbed, meaning that it can reach all key sites in the body
where the virus multiplies.
When taken within 48 hours of symptom onset, research shows Tamiflu can
reduce duration of illness by 1.3 days. Clinical trials also indicate that
Tamiflu is up to 89 percent effective in preventing flu, when taken within
48 hours of exposure.
Manufacturing Capacity
The broad availability of Tamiflu for both seasonal and pandemic use is
due to expanded global production capacity, which will reach the rate of
400 million treatment courses annually by the end of 2006, a more than
10-fold increase since 2004. The expansion includes a fully functioning
U.S.-based supply chain for Tamiflu with an annual capacity of 80 million
treatment courses. With Roche sites as well as external contractors
throughout the country, the U.S. supply chain encompasses all aspects of
Tamiflu production, from synthesis of the initial starting material
(shikimic acid) through all major steps of manufacturing to finished packs.
It was developed by Roche at the request of the U.S. Department of Health &
Human Services (HHS).
Roche and its affiliates have received and are filling on schedule
orders from more than 75 countries to-date for stockpiling Tamiflu. Roche's
global network for the manufacture of Tamiflu includes several Roche sites
and more than 15 external contractors located in nine different countries
around the world.
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:
rocheusa or roche.us.
(1) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
cdc/mmwr/preview/mmwrhtml/rr55e628a1.htm (p. 24)
(2) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
(3) cdc/flu/keyfacts.htm
(4) David Cutler, Harvard University health economist. "Flu vaccine
shortage could cost U.S. $20 billion," Associated Press, October 21,
2004.
(5) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
cdc/mmwr/preview/mmwrhtml/rr55e628a1.htm (p. 26-7)
U.S., with more than double the stock available last season. Tamiflu is
indicated for the treatment and prevention of influenza in adults and in
children 1 year and older.
"During the past year, Roche has continued to take all necessary steps
to ensure that Tamiflu is available for pandemic preparedness as well as
seasonal flu, in keeping with the recommendations of public health
officials and the needs of our customers," said George Abercrombie,
President and CEO, Hoffmann- La Roche Inc. "Physicians can be confident
that Tamiflu will be readily and widely available to patients who need it
for flu treatment and post-exposure prevention."
While Tamiflu has been widely associated with pandemic preparedness, it
was developed for seasonal flu prophylaxis and treatment. Roche has a
proactive inventory management plan in place that is designed to ensure
that Tamiflu is available to patients when and where it is needed.
According to recommendations issued in June by the U.S. Centers for
Disease Control and Prevention, oseltamivir (Tamiflu) and zanamivir
(Relenza) should be prescribed if an antiviral medication is needed for
seasonal flu treatment or prophylaxis.(1) Due to high levels of resistance,
CDC recommends against the use of two other antiviral agents, amantadine
and rimantadine, until susceptibility of these agents has been
re-established among circulating influenza A viruses.(2)
Influenza is a serious illness that affects up to 40 million Americans
every year, causing disruption to their daily lives, and leading to 200,000
hospitalizations and 36,000 deaths annually.(3) In a typical year, it is
estimated that influenza may result in as much as $10 billion in lost
productivity.(4)
While vaccine is the first line of defense against seasonal influenza,
prescription antiviral medications like Tamiflu play an important role in
prevention and treatment of influenza. Prophylactic use of antivirals is
recommended by the CDC for people at high-risk of influenza as well as
health care workers and institutional settings, such as nursing homes.(5)
How Tamiflu Works
Tamiflu belongs to a class of antiviral medicines called neuraminidase
inhibitors (NAI), which help prevent the flu virus from spreading inside
the body. Virtually all common flu viruses have the neuraminidase protein
on their surface, which enables them to migrate from cell to cell,
replicating and spreading throughout the body. Inhibiting the neuraminidase
activity is believed to interfere with this process, possibly causing the
viruses to become trapped and die out. Tamiflu is given orally and is
systemically absorbed, meaning that it can reach all key sites in the body
where the virus multiplies.
When taken within 48 hours of symptom onset, research shows Tamiflu can
reduce duration of illness by 1.3 days. Clinical trials also indicate that
Tamiflu is up to 89 percent effective in preventing flu, when taken within
48 hours of exposure.
Manufacturing Capacity
The broad availability of Tamiflu for both seasonal and pandemic use is
due to expanded global production capacity, which will reach the rate of
400 million treatment courses annually by the end of 2006, a more than
10-fold increase since 2004. The expansion includes a fully functioning
U.S.-based supply chain for Tamiflu with an annual capacity of 80 million
treatment courses. With Roche sites as well as external contractors
throughout the country, the U.S. supply chain encompasses all aspects of
Tamiflu production, from synthesis of the initial starting material
(shikimic acid) through all major steps of manufacturing to finished packs.
It was developed by Roche at the request of the U.S. Department of Health &
Human Services (HHS).
Roche and its affiliates have received and are filling on schedule
orders from more than 75 countries to-date for stockpiling Tamiflu. Roche's
global network for the manufacture of Tamiflu includes several Roche sites
and more than 15 external contractors located in nine different countries
around the world.
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:
rocheusa or roche.us.
(1) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
cdc/mmwr/preview/mmwrhtml/rr55e628a1.htm (p. 24)
(2) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
(3) cdc/flu/keyfacts.htm
(4) David Cutler, Harvard University health economist. "Flu vaccine
shortage could cost U.S. $20 billion," Associated Press, October 21,
2004.
(5) Prevention and Control of Influenza: Recommendations of the Advisory
Committee on Immunization Practices.
cdc/mmwr/preview/mmwrhtml/rr55e628a1.htm (p. 26-7)
Комментариев нет:
Отправить комментарий