The five-year agreement is part of the US government effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency, and likely stems from the shortages the country suffered as a result of the suspension of Chiron's flu vaccine last year. It is Sanofi Pasteur's seventh global initiative to help protect the public from a pandemic's serious health impact.
According to the World Health Organisation (WHO), the next pandemic is likely to result in 1 to 2.3m hospitalisations and 280,000 to 650,000 deaths in industrialised nations alone. Its impact will most likely be even more devastating in developing countries.
Under the terms of the agreement, Sanofi Pasteur will accelerate its cell-culture influenza vaccine program which is based on the PER.C6 cell-line technology of Crucell, a Dutch biotechnology company. In addition, Sanofi Pasteur will deliver to the US Health and Human Services Department (HHS) a feasibility plan for the construction of a US-based and licensed cell-culture production plant for supplying up to 300m monovalent influenza vaccine doses annually.
Cell culture is an emerging technology that eliminates chicken eggs for the production of influenza vaccine. Vaccines are a biologic product in which a selected strain of influenza virus is grown in a medium. Chicken eggs have provided the most advantageous and reliable method for producing influenza vaccine.
With cell culture, the virus is grown on specially selected cell lines instead of eggs. Besides eliminating the need for chicken eggs, the cell culture process has the potential to reduce, from four weeks to two or three weeks, the start-up time for manufacturing once the virus strain has been identified and could result in a more predictable manufacturing process.
The HHS agreement will also see Sanofi undertaking three major initiatives, the first of which will accelerate of Sanofi's development of a cell-culture influenza vaccine. The agreement expects Phase 1 and 2 clinical studies to be completed and Phase 3 to be underway.
The second initiative is the creation and design of a manufacturing process to produce the new cell-culture influenza vaccine in large quantities. Under the terms of the contract, Sanofi's will accelerate the existing project in order to complete a design approximately two years earlier than originally intended. The company will entirely refit a vaccine development facility for the project and design and test the process from small to mid-sized industrial scale.
The third initiative sees the establishment of a cell-culture vaccine manufacturing facility in the US. The plan will include feasibility studies and basic and detailed engineering plans covering the construction and validation of the proposed plant. The contract does not include the actual construction of the plant.
In December 2003, Sanofi and Crucell entered into a strategic agreement to further develop and commercialise a new influenza vaccine based on Crucell's proprietary PER.C6â cell line technology.
The agreement, worth an estimated €30m in licence fees and milestone payments for the Dutch firm, covers both pandemic and epidemic influenza vaccines, which up to now have been part of Crucell's in-house product development programme.
Sanofi-Aventis is market leader in the production and marketing of flu vaccines, with an estimated 38 per cent share of the global market in 2002 from sales of €460m.