About Us Solvay Biologicals, LLC is a wholly-owned subsidiary of Solvay Pharma US Holdings, Inc., the same parent company of Solvay Pharmaceuticals, Inc. Launched in January 2008, the company focuses exclusively on the research and development and ultimately, the manufacturing of the company’s cell-based influenza vaccine in the U.S.  Mission Solvay Biologicals aims to prevent and protect the American public from the onset and spread of influenza through innovative and pioneering research and manufacturing technology. The company furthers Solvay Pharmaceuticals’ dedication to optimal patient health management and well-being worldwide. Partnering with the United States Government In May 2006, Solvay Pharmaceuticals was awarded a $298 million, five-year contract from the U.S. Department of Health and Human Services (HHS) to develop cell-based influenza vaccines and plan for domestic manufacturing capacity in the U.S. The milestone-based contract, awarded to Solvay Pharmaceuticals in the U.S., covers the development and testing of new influenza vaccines including pandemic vaccines that are produced using cell-based technology.  The contract provides for the development of a master plan to manufacture, formulate, fill and package annual and pandemic influenza vaccines in a new U.S.-based facility.  Other activities supported by the award include the submission of an Investigational New Drug (IND) application, pre-clinical and clinical studies for seasonal and pandemic-like vaccines, and a Biologics License Application (BLA) allowing for the distribution and marketing of influenza vaccines in the U.S.  The award also includes funding to support development and design costs associated with establishing a new U.S.-based influenza vaccine manufacturing facility. The goal of the contract award is to generate the capability in the U.S. to produce at least 150 million doses of pandemic vaccine within six months of the start of a pandemic. At this time, a site to build the manufacturing plant in the U.S. has not been selected. Solvay Pharmaceuticals and Solvay Biologicals continue to work with HHS and the Food and Drug Administration to achieve milestones within the project with the ultimate goal of offering Americans protection against a possible pandemic. History Solvay’s 50-year History in Influenza Franchise Solvay Pharmaceuticals has been a major worldwide supplier of influenza vaccines since the late 1940s and is an innovator in this area.  The European-based Solvay Biologicals, B.V. unit of Solvay Pharmaceuticals currently manufactures and markets an egg-derived influenza vaccine in 58 countries worldwide; however, this product is not marketed in the U.S. Our 15-year Experience in Cell-based Technology Solvay Pharmaceuticals was the first influenza vaccine provider in the world to receive approval from a regulatory authority for continuous cell line technology.  This cell-based vaccine was licensed by the Dutch authorities in 2001.  The new technology adds flexibility and efficiency to the current vaccine production method using a continuous cell line rather than chicken eggs. This process provides better control of product quality and the capacity to respond to a demand surge in the event of an influenza pandemic.  Furthermore, this state-of-the-art production technology is not dependent on chicken egg supply logistics or the ability of the virus to sufficiently grow in chicken eggs.  In June 2005, the company submitted a drug master file (DMF) to the U.S. Food and Drug Administration (FDA) for its cell-derived influenza vaccine. The company has filed an IND and initiated human clinical trials using commercial scale vaccine from its cell-based vaccine facility in The Netherlands.