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Basel, 18 October, 2005
Further expansion of
Tamiflu manufacturing capacity
Roche reiterates willingness to
enter discussions with governments and other manufacturers on the production of Tamiflu for emergency
pandemic use.
Roche announced today that the Food and Drug Administration
(FDA) has granted approval of an additional capsule manufacturing site in the US for the supply of the
influenza antiviral Tamiflu (oseltamivir), expanding its already significantly increased worldwide production
capacity.
This 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.
William
M. Burns, CEO Roche Pharma Division, commented: "For Tamiflu, the key need today is the rapid expansion
of production capacity. Patients' needs in case of a pandemic remain our top priority. We have already
significantly expanded production capacity internally and by working in close collaboration with other
companies, and we will continue to do so. In addition, we are prepared to discuss all available options,
including granting sub-licenses, with any government or private company who approach us to manufacture
Tamiflu or collaborate with us in its manufacturing. In support of the global effort to fight a potential
pandemic, we would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu,
provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic
use, in accordance with appropriate quality specifications, safety and regulatory guidelines".
Tamiflu
is designed to be active against all clinically relevant influenza viruses and key international research
groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian
H5N1 strain circulating in the Far East. As a result, more governments are stockpiling Tamiflu therefore
Roche is expanding a collaborative production network to meet the increasing demand. The manufacturing
process for Tamiflu is complex and lengthy.
Roche has been working with
many governments over the last few months to determine their needs for stockpiling of Tamiflu and has
received and/or fulfilled orders from around 40 countries.
About
Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically
relevant influenza viruses.3 It works
by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase
is inhibited, the virus is not able to spread to and infect other cells in the body.
Tamiflu
delivers:
• 38 percent reduction in the severity of symptoms1
•
67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise
healthy individuals2
•
37 percent reduction in the duration of influenza illness5,3
•
Tamiflu was shown to provide up to 89 percent overall protective efficacy against
clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients4
In children, Tamiflu delivers:
• 36 percent reduction
in the severity
and duration of influenza symptoms5
•
44 percent reduced incidence of associated otitis
media as compared to standard care6
As
with any antiviral, a theoretical
potential exists for an influenza virus to emerge with decreased sensitivity to a drug. Extensive monitoring,
by Roche and the independently established Neuraminidase Inhibitor Susceptibility Network (NISN) measured
the incidence of resistance to NAIs. From around 4000 patients treated with Tamiflu resistance was encountered
in 0.4 per cent in adults and 4 per cent in children aged one to 12. This resistant virus was found
to be less virulent than the wild type virus and did not affect the course of the illness.
The
greatest use of Tamiflu today is in Japan. To illustrate this, there were an estimated 16 million influenza
infections in Japan over the 2004/2005 influenza season. Roche estimates that around 6 million of those
individuals infected with the influenza virus received Tamiflu. Even with this degree of usage, resistance
appears very infrequent.
Avian Influenza and Pandemics
Most
avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus
co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which
may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely
new in composition, so vaccines developed and administered to date to protect humans during seasonal
epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection.
Experts believe the next influenza pandemic could result from such a mutation of virus strains.
World
Health Organisation
The WHO has recommended as part of its Pandemic Preparedness
Plan
that countries establish stockpiles of antiviral treatments such as Tamiflu, which are effective against
all strains of the influenza virus. The Pandemic Preparedness Plan, along with details of the 15 countries
that have implemented national plans, can be viewed on the Internet.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused
healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes
on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader
in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader
in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while
the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people
in 150 countries and has R&D agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
All
trademarks
used or mentioned in this release are legally protected.
Additional
information
- Roche Health-Kiosk, Influenza
-
About Tamiflu
- About influenza
-
WHO: Global influenza programme
- WHO: Avian flu
1
Treanor JJ et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating
acute influenza: a randomized, controlled trial. JAMA 2000;283: 1016–24
2 Kaiser
et al. Impact of Oseltamivir treatment on influenza-related lower respiratory tract complications and
hospitalisations. Arch Intern Med. 163:1667-1672 (2003)
3 Nicholson KG et al. Efficacy
and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet 2000;
355:1845–1850
4 Welliver R. W. et al. Effectiveness of oseltamivir in preventing
influenza in household contacts: a randomized controlled trial. JAMA, 2001 Feb 14; 285(6): 748-754
5
Whitely RJ, Hayden FG et al; Oral oseltamivir treatment of influenza in children, Pediatr Infect
Dis J 2000; 20: 122-133
6 Roche data on file, 2003 |
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