Media Release
Basel, 16 May 2006
Roche
reaches agreement with Aspen to provide influenza medicine for Africa
Roche
today announced that it has reached an agreement with the South African company Aspen for the production
of a generic version of oseltamivir for Africa, as part of continued efforts to increase and speed up
availability of the medicine for influenza pandemic planning world wide. The agreement with Aspen is
focused on providing oseltamivir for pandemic use to further help to address the needs of governments
and other not for profit organisations in the African sub- continent. Roche will provide technical know
how (technical, pre-clinical and clinical data) to assist Aspen to help them expedite their production
and the registration. The agreement also allows the supply of Active Pharmaceutical Ingredient (API)
from Roche to Aspen.
David Reddy, Roche’s Pandemic Taskforce Leader,
commented: “We are pleased to announce the partnership with Aspen as the latest step in our scale-up
efforts to meet the needs of governments in preparing for the potential public health threat posed by
avian influenza. This is another demonstration of Roche’s commitment to working as a collaborative and
responsible partner with governments and the World Health Organization (WHO) to assist in pandemic planning”.
Whilst Roche remains on schedule to meet all orders from African governments
by early 2007, the collaboration with Aspen will further enhance the supply of oseltamivir for Africa.
The agreement is non-exclusive and will mean that Roche and other sub-licensees will be able to work
on pandemic orders within Africa.
Supporting global efforts
for pandemic preparedness
Roche has been in discussions with governments as early
as 1997 regarding pandemic preparedness and in the last few years, has received orders and letters of
intent for Tamiflu from over 75 governments around the world for pandemic stockpiling and is fulfilling
all orders according to the agreed upon schedule.
Clearly, anti-viral
medicines like Tamiflu are an important component of any pandemic preparedness plan. To meet this demand,
by working with third parties, Roche has substantially increased the production of Tamiflu and are in
a position to produce 400 million treatments annually by the end of this year. In addition, sub-licensing
agreements have been granted to companies in China and India for production of oseltamivir.
Roche
donations to WHO
During discussions with governments, it became clear that developing
nations were the least prepared in terms of antiviral stockpiling. Subsequent discussions between Roche
and WHO led to the concept of a rapid response stockpile of 3 million treatments, 1.5 million treatments
being stored in Kaiseraugst, Switzerland and 1.5 million treatments stored in Nutley, US. The idea of
such stock is to use the medicine as a fire blanket, to contain a pandemic where it starts.
Under
a separate agreement, Roche has also donated a further two million treatment courses to WHO for use
in those developing countries which are most likely to be affected by avian influenza in humans and
are unable to afford the drug. These treatment courses can be used by WHO according to its assessment
of the situation, and will be available for delivery at the end of the year.
About
Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically
relevant influenza viruses and 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.
Roche and Gilead
Tamiflu
was invented by Gilead Sciences and licensed to Roche in 1996. Roche and Gilead partnered on clinical
development, with Roche leading efforts to produce, register and bring the product to the markets. Under
the terms of the companies’ agreement, amended in November 2005, Gilead participates with Roche in the
consideration of sub-licenses for the pandemic supply of oseltamivir. To ensure broader access to Tamiflu
for all patients in need, Gilead has agreed to waive its right to full royalty payments for product
sold under these sub-licenses.
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
2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division
posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has
R&D agreements and strategic alliances with numerous partners, including majority ownership interests
in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Additional information
- About Aspen
- Roche Health Kiosk, Influenza
- About Tamiflu
- About influenza
- WHO: Global influenza programme
- WHO: Avian flu