SAN DIEGO, Dec. 7 /PRNewswire/ -- Study results from Bayer Biological Products (BP) presented today at the annual meeting of the American Society of Hematology (ASH) in San Diego, Calif., showed no increase in adverse events associated with an increased maximum infusion rate of Gamunex(R), Bayer BP’s advanced immune globulin intravenous (IGIV), in patients with idiopathic [immune] thrombocytopenic purpura (ITP).
ITP is an autoimmune disorder of unknown cause that affects both children and adults. It occurs when the immune system malfunctions and produces antibodies against the body’s own platelets, resulting in a decreased level of blood platelets needed for normal blood clotting. This can lead to life- threatening bleeding episodes. Gamunex is a lifesaving therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is used to treat a variety of health problems and can be used for either immune replacement or immune modulation. In ITP, Gamunex acts as an immune modulator, regulating the platelet count.
The Gamunex study presented at ASH observed that, based on a dose of 1 g/kg for a 70 kg patient, a faster infusion rate resulted in an average time saving of nearly 50 minutes per infusion, approximately one-third of the total infusion time compared to the currently approved maximum infusion rate. The incidence of infusion-related adverse events was similar for both the currently approved maximum rate and the higher rate evaluated in this study. The time saved with the more rapid rate of infusion may enhance patient compliance, limit loss of time from work or school, and reduce medical and nursing costs.
“We are encouraged by the tolerability of Gamunex, even at higher infusion rates, which we observed in this small clinical trial,” said the study’s principal investigator James Bussel, M.D., professor of pediatrics with secondary appointments in OBGYN and Medicine, New York Presbyterian Hospital. “The time savings with the more rapid rate of infusion may be a benefit to patients, as well as providing greater efficiency, and thereby cost savings, i.e., reduced need for doctor or nurse time.”
The Gamunex Commitment
Because the production method determines the efficacy, tolerability, and safety of an IGIV product, Bayer BP used a “clean sheet” approach to develop a completely new and optimal production process for Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified. This innovative process includes breakthrough purification steps using Caprylate/Chromatography that improve product purity. This new approach also helps preserve the biological activity of the product by replacing the solvent-detergent method used in previous generations of IGIV products. Bayer invested more than $250 million in a new state-of-the-art-production facility designed and built around the new Gamunex manufacturing process. The facility is the first of its kind dedicated solely to the production of IGIV, allowing Bayer to produce a reliable and consistent supply of Gamunex. To support the regulatory approvals of Gamunex in the United States, Canada, and Germany, Bayer invested in the largest and most rigorous clinical trials program in IGIV history, which demonstrated excellent efficacy, safety, and tolerability of Gamunex in patients with ITP and in patients with primary immunodeficiency diseases (PID).
Trial Design
ITP patients in the United States were studied to determine the safety and tolerability of Gamunex at a higher infusion rate in a randomized, single center, open label, cross-over study. By studying Gamunex at the FDA-approved infusion rate of 0.08 mL/kg/min (or 4.8 mL/kg/hour) compared to a more rapid rate of 0.14 mL/kg/min (or 8.4 mL/kg/hour), the study center could determine if the frequency and severity of adverse events increased with a faster infusion rate.
Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, was administered at a dose of 1.0 g/kg to each patient in the study on two occasions as a single-daily infusion over a maximum interval of six weeks. Patients were randomized into two groups, with one group receiving Gamunex at the standard maximum rate and the other receiving the higher rate in the first infusion. In the second infusion, each group received infusions at the opposite rate. A total of eight patients received the standard infusion rate, and seven patients received the faster infusion rate. No steroid pre- medication was permitted for either infusion rate.
Clinical Endpoints and Key Findings
Results demonstrated that the incidence of infusion-related adverse events was similar for both infusion rates. None of the treatment-emergent events were severe for either infusion rate -- in fact, 84 percent of the events observed in this study were mild in nature, with the most commonly reported adverse event being a headache. The higher infusion rate demonstrated an average time saving of 48.4 minutes, or approximately one-third of the infusion time compared to the current approved maximum infusion rate, with a mean duration of 97.86 plus/minus 6.36 minutes for the faster infusion rate, compared with 146.25 plus/minus 5.82 for the standard rate.
Results of this study were consistent with a previous study of 28 ITP patients (Journal of Allergy and Clinical Immunology 2003; 111: a632).
In addition to the ITP infusion rate study, Bayer BP, as part of its ongoing commitment to clinical, evidence-based medicine, recently completed a third study evaluating the faster maximum infusion rate in patients with primary immunodeficiency disease (PID). Bayer BP plans to present the results of the PID study at the annual meeting of the American Academy of Allergy Asthma & Immunology in March 2005.
The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. For additional information on Gamunex, see Full Prescribing Information at http://www.gamunex.com/ .
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.
Information about Bayer Biological Products Division can be found at http://www.bayerbiologicals.com/ .
Forward-looking Statements
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.
Bayer Biological Products
CONTACT: Tricia McKernan of Bayer Biological Products, +1-919-316-6316,or fax, +1-919-316-6673, tricia.mckernan.b@bayer.com
