Bayer HealthCare Pharmaceuticals, Amerinet Extend Contrast Media Agreement
WAYNE, N.J., April 8, 2008 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the company has been awarded a two-year contract by Amerinet, Inc. to make Magnevist(R) (gadopentetate dimeglumine) injection and Ultravist(R) (iopromide) injection available to members of the Amerinet network.
Amerinet is a leading national health care group purchasing organization that serves more than 26,000 acute and non-acute healthcare providers nationwide. Through its Total Spend Management Solutions program, Amerinet strategically partners with health care providers to improve its customers’ operating margins by creating efficiencies, reducing costs and identifying new revenue streams. The company is based in St. Louis, with offices in Salt Lake City, Utah, Providence, R.I., and Warrendale, Pa.
“We are pleased to continue our long-standing relationship with Amerinet and remain committed to providing its members with the high-quality, cost-effective products they need to serve their patient community,” said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals.
The agreement is effective March 1, 2008 through 2010. It covers Magnevist in multiple presentations, including 5, 10, 15 and 20 mL single-dose vials, 50 and 100 mL pharmacy bulk packages, and 10, 15 and 20 mL pre-filled syringes of Magnevist. Ultravist will be available in four concentrations (150, 240, 300 and 370 mgI) and in a variety of product presentations, including 500 mL pharmacy bulk packages for the 300 mgI and 370 mgI concentrations.
Magnevist is currently the leading MRI contrast agent in the US and worldwide, a position attained through a combination of high product quality and outstanding customer service. Since its introduction, Magnevist has been used in over 90 million procedures worldwide and continues to be the most studied MRI contrast agent on the market. It currently has the broadest range of FDA-approved indications for adult and pediatric patients. For more information about approved indications, please visit http://www.imaging.bayerhealthcare.com/html/magnevist/prescribing_info.html.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk of Nephrogenic Systemic Fibrosis in patients with:
— acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 m2), or -- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid the use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non- contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.
MAGNEVIST(R) (gadopentetate dimeglumine) injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other paramagnetic contrast agents, caution should be exercised in patients with renal insufficiency, due to the possibility of further deterioration in renal function. As with other injectable products, cases of phlebitis and thrombophlebitis have been reported; assessment of the dosed limb for the development of injection site reactions is recommended.
Safety and efficacy in children under the age of 2 years have not been established.
ULTRAVIST(R) (iopromide) injection is a well-tolerated, non-ionic, iodinated, low osmolar radiological contrast imaging agent for intravascular administration. Its low viscosity helps enable ease of administration and rapid iodine delivery rate. Through clinical experience in over 100 million patients worldwide, Ultravist has been shown to offer a combination of contrast quality with a well-established general and local tolerability profile. It has been shown to be safe and effective in all major intravenous and intra-arterial indications.
Ultravist is offered in four concentrations: 150, 240, 300 and 370 mg iodine per mL. The 370 mg of iodine is the highest commercially available iodine concentration in the United States. In the United States, Ultravist is available in a variety of vial sizes, including a 500mL Pharmacy Bulk Package.
ULTRAVIST(R) (iopromide) injection: All non-ionic, iodinated contrast media currently available inhibit blood coagulation in vitro less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing non-ionic contrast media. Therefore, meticulous intravascular administration technique is necessary to minimize thromboembolic events. As with all iodinated contrast agents, serious or fatal reactions have been associated with their use.
ULTRAVIST injection is not indicated for intrathecal use. About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
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 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 HealthCare Pharmaceuticals Inc.
CONTACT: Joanne Marlin, Bayer HealthCare, +1-973-305-5383
Web site: http://www.berlex.com/