RESEARCH TRIANGLE PARK, N.C., March 3 /PRNewswire/ -- Bayer HealthCare LLC, Biological Products Division (Bayer BP), has received marketing authorization for Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, from the Paul Ehrlich Institute (PEI), Germany’s regulatory authority for biological products. Gamunex is a completely new and advanced immunoglobulin (IGIV) product, not only based on an innovative production process, but also produced in a 100 percent dedicated facility -- the only one of its kind worldwide. Gamunex builds on the strong benefits of Bayer BP’s Polyglobin, a trusted IGIV brand in Germany, while advancing IGIV treatment based on excellent efficacy, tolerability, and safety, as demonstrated in unprecedented clinical trials. Approval in Germany represents another major milestone in the phased global launch of Gamunex and is a first step in providing the newest IGIV treatment to patients in Europe. Gamunex has been introduced successfully in the United States and Canada following regulatory approval in both markets August 2003.
Each vial of Gamunex contains antibodies purified from the donated blood plasma of thousands of people and can be a lifesaving therapy for individuals with compromised, missing, or malfunctioning immune systems. The immune system serves as the body’s natural defense system, constantly fighting off infections caused by harmful bacteria and viruses that invade the body. When parts of the immune system are missing, as in patients with primary immune deficiencies, the body is vulnerable to attack by these invaders. In those cases, the broad spectrum of antibodies in Gamunex acts as an immune system replacement and provides a shield of protection against infection.
For people with autoimmune disorders and other conditions that cause the immune system to malfunction, such as idiopathic thrombocytopenia purpura (ITP), Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, acts as an immune modulator. Normally, the immune system recognizes and attacks only foreign invaders. However, when the immune system malfunctions, it “sees” the body’s own tissues or cells as foreign and begins to attack. As an immune modulator, Gamunex regulates or resets the immune system so it can function normally again.
A New Approach to IGIV - The Process Is the Product
In seeking to create an advanced next-generation IGIV product, Bayer BP quickly discovered how an IGIV product is made may affect how well the product works for patients. Because the protein structure of antibodies is so fragile, the specifics of the IGIV manufacturing process directly affect the efficacy, tolerability, and safety of the product. Bayer BP’s scientists developed an optimal and gentle production process that uses caprylate/chromatography, a breakthrough purification process that improves product integrity, purity, and production reliability. The new process used to produce Gamunex provides added benefits to patients and their treating physicians. Caprylate is a plant-derived natural substance that is proven to safely, effectively, and rapidly inactivate enveloped viruses, such as HIV, hepatitis B, and hepatitis C. Bayer BP designed and built a new facility to house the innovative new purification process, the only facility of its kind in the world dedicated solely to the production of IGIV.
“When I first learned about Gamunex, I became very excited to try this new product. Now that I am using it, I feel great and am delighted to know that, now, patients in Germany will have access also,” said John Boyle, a U.S. patient who has converted to Gamunex. “Knowing the product is supported by the largest clinical trials program in IGIV history gave me and my immunologist great confidence to try Gamunex. I am pleased with the choice we made, since I already am experiencing the benefits of Gamunex.”
Gamunex is formulated without sugar stabilizers, which have been associated with severe adverse reactions in other IGIV products. In addition, the approval of Gamunex in Germany offers IGIV patients the unique combination of a ready-to-use, highly purified, 10% formulation and a safe and rapid infusion rate, giving time back to patients and the health care providers that care for them.
Unprecedented Clinical Trials
Approval of Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, in all markets was based on the largest and most robust clinical trials program ever conducted to support an IGIV product. These groundbreaking studies provided, for the first time in IGIV history, clinical evidence for the excellent efficacy, safety, and tolerability profile of an IGIV product.
“Approval from the Paul Ehrlich Institute, combined with recent approvals from both the FDA and Health Canada, underscores the strength of the clinical trial data and excellent efficacy, tolerability, and safety profile of Gamunex,” said Jerry Winkelstein, M.D., director of the Division of Immunology, Department of Pediatrics at Johns Hopkins University School of Medicine. “The unprecedented trial size and design provide unique evidence for the efficacy of an IGIV product.”
Gamunex offers an important lifesaving treatment for thousands of patients in Germany affected by a wide range of conditions. Gamunex is approved in Germany as replacement therapy for primary immunodeficiency (PI) diseases(1), a group of conditions caused by genetic defects in the immune system. Gamunex also is indicated for immunomodulation in the treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, Kawasaki Syndrome, and Guillan-Barre Syndrome. Other approved indications include secondary immunodeficiency due to multiple myeloma, chronic lymphocytic leukemia, pediatric HIV infection, and allogenic bone marrow transplantation. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. For additional information on Gamunex, see http://www.gamunex.com/.
“This approval in Germany is a significant step forward as we begin to realize the tremendous potential for Gamunex in the worldwide IGIV market,” said Joseph Akers, president, Bayer BP. “As part of our ongoing commitment, we built a state-of-the-art manufacturing facility to house the revolutionary new production process for Gamunex. In addition, we’re already investing in the next phase of development with clinical studies in neurological disorders, including multiple sclerosis and chronic inflammatory demyelinating polyneuropathy. We hope that these studies will allow additional patients to realize the benefits of Gamunex.”
Gamunex is now available in the United States and Canada through traditional product distribution channels and will be available to patients in Germany in the fall of 2004.
About Bayer HealthCare
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 9.4 billion Euro in 2002, 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, and Pharmaceuticals. More than 34,000 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.
About The Paul Ehrlich Institute
The Paul Ehrlich Institute (PEI) has been playing a major role in controlling the safety and efficacy of biological drugs since they were first used in therapy and prophylaxis more than one hundred years ago, when it operated under a different name with the Nobel prize winner Paul Ehrlich as its head. Since then, a wealth of experience has been accumulated about the successes and the risks of using biological drugs. It is this basis which enables the staff members of the Paul Ehrlich Institute to fulfill their most important task: using their knowledge and expertise in the field of biological drugs to serve the health of humans and animals. The granting of marketing authorizations and the release of batches are the most important, but not the only, tasks with which PEI has been entrusted by statutory provisions. For example, PEI also does research work and acts in an advisory capacity in the development of innovative drugs.
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.
(1) Primary immunodeficiency diseases also are known as PI diseases,
PIDD, and PID.
Bayer Biological Products
CONTACT: Tricia McKernan of Bayer Biological Products, +1-919-316-6316,tricia.mckernan.b@bayer.com
Web site: http://www.gamunex.com/
