Solvay Pharmaceuticals, Inc. Submits Drug Master File for Cell-Derived Influenza Vaccine to U.S. Food and Drug Administration
Cell Culture Production Facility Construction Completed in The Netherlands
MARIETTA, Ga. — June 7, 2005 — Solvay Pharmaceuticals, Inc. announced today that it has submitted a drug master file (DMF) to the U.S. Food and Drug Administration (FDA) for its cell-derived influenza vaccine. Following submission of the DMF and the validation of its cell culture production facility, the company plans to submit an investigational new drug application to the FDA to evaluate the safety and efficacy of the product in clinical trials. The state-of-the-art Netherlands-based production facility will be utilized to produce clinical batches of the cell-derived vaccine for use in initial U.S. clinical trials.
A DMF submission to the FDA may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of a drug product. Solvay Pharmaceuticals’ DMF submission contained extensive chemistry, manufacturing and control and pre-clinical data from recently completed studies conducted to further characterize the cell culture utilized in Solvay Pharmaceuticals’ production process.
“Although Solvay Pharmaceuticals has been a major supplier of influenza vaccines in Europe for decades, this will be an important new business segment for our U.S. pharmaceutical business,” said Harold Shlevin, President and CEO of Solvay Pharmaceuticals, Inc. “We recognize the importance of providing alternative sources of flu vaccine to the U.S. market, especially in light of recent public health concerns.”
Solvay Pharmaceuticals, a major supplier of influenza vaccines since the late 1940s and an innovator in this area, recently launched a novel virosomal vaccine, Invivac, in several European markets. The European-based Business Group Influenza unit of Solvay Pharmaceuticals currently manufactures and markets an egg-derived influenza vaccine for other parts of the world; however, this product is not approved for use in the U.S. Solvay Pharmaceuticals was the first company to receive a license for a cell-derived influenza vaccine when Dutch authorities licensed the product in 2001. The company began construction on its biosafety level 3 cell culture production facility in 2003.
Solvay Pharmaceuticals, Inc. of Marietta, Ga. (USA) is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets including men's health. It is a part of the global Solvay Pharmaceuticals organization whose core activities consist of discovering, developing and manufacturing medicines for human use. Solvay Pharmaceuticals, Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium.
