Bayer BP Sterile Filling Facility Receives Additional Regulatory Approvals
RESEARCH TRIANGLE PARK, N.C., Nov. 30 /PRNewswire/ — Bayer Biological Products (BP) announced approval by the U.S. Food and Drug Administration (FDA) and the European Commission to operate three additional freeze dryers in the new sterile filling facility located at Bayer BP’s Clayton, N. C., manufacturing plant. The freeze dryers, which Bayer BP will use in the manufacture of Prolastin(R), Alpha-1 Proteinase Inhibitor (Human), feature fully automated loading and unloading, further reducing the chance of operator error and increasing the reliability of the late stages of the manufacturing process for this important product.
“This approval reinforces our long-standing commitment to Prolastin(R) through continuing upgrades of the manufacturing processes at our outstanding Clayton facility,” said Joseph Akers, president, Bayer Biological Products Division. “The investment in our sterile filling facility has exceeded $65 million, and further demonstrates our nearly two decades of unwavering support to the alpha-1 patient community.”
Mary Kuhn, senior vice-president, operations, and Clayton site head, commented further on the importance of this approval. “The new freeze drying process represents the current state-of-the-art technology in automation of the final stage of the manufacturing process. As we continue to upgrade our facility in Clayton, we also remain committed to the development of future products and technologies. With this approval, additional space becomes available for further technology applications and development of manufacturing processes that will represent increased benefits to the patients we serve.”
Prolastin(R), Alpha-1 Proteinase Inhibitor (Human), as the first alpha-1 antitrypsin (AAT) augmentation therapy, has been available for nearly two decades. Throughout this time, Bayer BP has been a leading corporate citizen, providing millions of dollars for programs that provide support to patients and professionals in the global alpha-1 community. Bayer BP’s research and development programs continue to focus on new products, technologies, and clinical endpoints that advance care and increase the scientific body of knowledge for treatment of alpha-1 deficiency. As a leader in pathogen safety research and applications of comprehensive safety and quality management programs during manufacturing, Bayer BP is committed to providing the greatest possible safety for patients who receive Prolastin(R).
About Alpha-1 Antitrypsin Deficiency
Alpha-1 antitrypsin deficiency is a genetic lung disease, which is frequently accompanied by emphysema, and there is no cure for the disease. Alpha-1 antitrypsin deficient patients are marked with increased shortness of breath following an activity, decreased exercise tolerance, and wheezing. In addition, the disease can be complicated by dust, viral infections, pollution, mold, pollen, and cold weather. Symptomatic alpha-1 antitrypsin deficient patients may be treated with alpha-1 antitrypsin augmentation therapy which boosts serum levels of alpha-1 antitrypsin and may help to slow the progression of alpha-1 antitrypsin deficiency; however, this therapy is not available in all countries. According to the World Health Organization, alpha- 1 antitrypsin deficiency affects approximately 200,000 people in North America and Europe, although an estimated 90 percent of these patients are undiagnosed.
Prolastin(R), Alpha1-Proteinase Inhibitor (Human) is a sterile, stable, lyophilized preparation of purified human AAT prepared from pooled human plasma of healthy donors by a modification of the cold ethanol fractionation process. Prolastin(R) has an excellent safety record. There have been no documented reports of viral or infectious disease transmission to patients receiving Prolastin(R) in over 16 years of use, either in clinical studies or during postmarketing surveillance.
Prolastin(R) raises serum levels of AAT above a therapeutic threshold of 11Ã‚µm/L when given as weekly infusions of 60 mg/kg/body weight. Maintaining serum levels above 11Ã‚µm/L is thought to protect the lungs from further degradation by free elastase, and thus slow the progression of the lung disease. However, because of the complex nature of the disease, no clinical trials have been performed to definitively prove this thesis.
Weekly Prolastin(R) therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin(R), adverse reactions were observed in 1.16% of patients, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with any plasma-derived products, the theoretical risk of viral transmission cannot be ruled out.
About Bayer HealthCare AG
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world’s leading, innovative companies in the health care and medical products industry.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics Professional Testing Systems and Diagnostics Self Testing Systems and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.
Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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Bayer Biological Products (BP)
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