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FDA Approves Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified

http://www.docguide.com/news/content.nsf/News/8525697700573E1885256D90004146F3

August 28, 2003
Source: Bayer Biological Products
Research Triangle Park, NC

Bayer HealthCare LLC, Biological Products Division (Bayer BP), has received approval from the U.S. Food and Drug Administration (FDA) for Gamunex®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, its new and advanced immunoglobulin intravenous (IGIV) product. The approval of Gamunex in the United States, along with the recent approval in Canada, marks a major milestone in Bayer BP's more than 20 years of continuous commitment to improving product quality and reliability.

Each vial of IGIV contains antibodies purified from the donated blood plasma of thousands of people. These antibodies are essential as a life-saving therapy for patients with certain conditions that compromise their immune system. Because the protein structure of these antibodies is so fragile, the specifics of the manufacturing process, such as Bayer BP's Caprylate/Chromatography purification, have a direct impact on the quality of an IGIV product. As this treatment represents a life-saving therapy for patients with compromised immune systems, a high quality product is critical.

"Gamunex advances treatment for individuals with compromised immune systems," said Dr. Ronald Sacher, M.D., professor, Internal Medicine and Pathology, and director, Hoxworth Blood Center, University of Cincinnati Medical Center. "Bayer BP's strong clinical data provides confidence in the proven efficacy of Gamunex without compromising safety and excellent tolerability. I believe this demonstrates not all IGIVs are the same."

Addressing an Unmet Need in the Market

In a survey conducted in June 2003 by the Immune Deficiency Foundation, Americans with primary immunodeficiency (PI)(1) diseases, the major licensed indication for IGIV, expressed a desire for safe, convenient, and reliable products that offered enhanced efficacy and excellent tolerability. These survey findings validate Bayer BP's commitment to develop a new and differentiated, next-generation IGIV product that meets the changing needs of both patients and the health care professionals who treat them.

As part of this commitment, Bayer BP initiated the largest and most rigorous clinical trials program in IGIV history to support FDA approval of Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified. The PI study results demonstrate the excellent efficacy, safety, and tolerability of Gamunex, with patients in the Gamunex group experiencing a significant reduction in annual validated infection rates.

"The approval of Gamunex in the United States is a great opportunity for our business and provides patients with the newest treatment available," said Dr. Gunnar Riemann, president, Bayer Biological Products Division. "Approval in the United States and Canada allows us to implement our phased global launch strategy, with an initial focus on North America, the largest IGIV market in the world."

A Gentle Process Means a Better Product

Because the production method determines a plasma product's efficacy, tolerability, and safety, Bayer BP used a "clean sheet" approach to develop an optimal production process for Gamunex. Other IGIV products are based on retrofitted methods first introduced in the 1940s and '50s, which no longer provide a viable platform for significant product improvements. This innovative process includes breakthrough purification steps using Caprylate/Chromatography that improves product purity and supply reliability.

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. In addition, Caprylate is a naturally occurring fatty acid that effectively, safely, and rapidly inactivates enveloped viruses, such as human immunodeficiency virus (HIV-1), West Nile virus, hepatitis B virus (HBV), and hepatitis C virus (HCV). Bayer BP built a state-of-the-art manufacturing facility to house the new Gamunex purification process, the only facility of its size exclusively dedicated to producing IGIV.

"We literally built the fully dedicated Clayton, N.C., facility around a newly designed process that is optimized to purify the highly sensitive immunoglobulin proteins in Gamunex," said Peter Clarke, Ph.D., director of manufacturing for Bayer BP. "It is through this innovative process that we were able to generate a totally new and unprecedented IGIV product with improved quality and reliability that will directly benefit patients."

Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, offers an important life-saving, usually life-long, treatment for thousands of patients with PI, a group of conditions caused by genetic defects in the immune system. Gamunex also is indicated for the acute and chronic treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, leading to occasional life-threatening bleeding episodes. 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.

Bayer BP also sees potential for Gamunex in other indications. In order to gain approval to provide additional patients with the option of being treated with Gamunex, Bayer BP already has commenced clinical trials to study treatment of neurological disorders, including multiple sclerosis and chronic inflammatory demyelinating polyneuropathy (CIDP). Gamunex will be available in the United States later this fall through traditional product distribution channels.

(1) Primary immunodeficiency diseases are also known as PI diseases, PIDD and PID
 

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