LYON, France and SWIFTWATER, Pa. -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, has been awarded a $97 million contract from the U.S. Health and Human Services Department (HHS) to speed the production process for new cell culture influenza vaccines in the U.S. and the design of a U.S.-based cell-culture vaccine manufacturing facility. Sanofi pasteur, the global leader in influenza vaccines, has assembled dedicated teams at its Swiftwater, Pa., and Marcy L'Etoile, France, sites to support this critical project.
The five-year agreement, the majority of which will be completed in three years, is part of the U.S. government's effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency and is sanofi pasteur's seventh global initiative to help protect the public from a pandemic's serious health impact.
As a result 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 N.V., a Dutch biotechnology company. In addition, sanofi pasteur will deliver to the HHS a feasibility plan for the construction of a U.S.-based and licensed cell-culture production plant for supplying up to 300 million monovalent influenza vaccine doses annually. This would add substantial capacity in the event of a pandemic. The HHS contract does not encompass the actual construction of the facility.
Under the HHS agreement, sanofi pasteur will undertake three major initiatives involving resources in several countries including sanofi pasteur's U.S. headquarters in Swiftwater, PA, the company's R&D and production site in Marcy l'Etoile, France, and Crucell's company headquarters and research center in Leiden, The Netherlands. The first initiative is the acceleration of sanofi pasteur's development of a cell-culture influenza vaccine. At the end of three years, Phase 1 and 2 clinical studies will be completed and Phase 3 will 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 pasteur 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 is the preparation of a comprehensive feasibility plan for establishing a cell-culture vaccine manufacturing facility in the U.S. 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 pasteur and Crucell entered into a strategic agreement to further develop and commercialize a new influenza vaccine based on Crucell's proprietary PER.C6 cell line technology.
Lonza Biologics plc., a biotechnology contract manufacturer and subsidiary of The Lonza Group, will contribute to key activities related to the scale up to very large volumes of PER.C6 cell culture and engineering design of the production facility.
Source: Sanofi pasteur