TARRYTOWN, N.Y. and WALTHAM, Mass., Nov. 22 /PRNewswire-FirstCall/ -- Bayer HealthCare, Diagnostics Division, a member of the Bayer Group and Inverness Medical Innovations, Inc. , a leading manufacturer and marketer of professional and consumer medical diagnostic products, announced today that the companies have signed four agreements to broaden their assay menu offerings worldwide in the diagnostics arena.
The first agreement will expand access for physicians and healthcare providers worldwide, excluding Japan, to diagnose congestive heart failure using a Point of Care assay for B-type Natriuretic Peptide (BNP) testing.
Recent research(1) has shown that elevated levels of BNP are an indicator of heart failure, thus providing physicians with an important diagnostic tool in the early detection and management of heart failure.
BNP is a rapidly expanding area for cardiovascular testing. The BNP molecule is physiologically active serving as a direct biological response to cardiovascular stress. This attribute allows BNP testing to provide a representation of a patient's cardiac situation at the time a blood sample is drawn, which in turn allows for more timely treatment and patient management. The use of BNP as an effective tool in the prognosis and management of heart failure makes it the molecule of choice (as identified by the U.S. News and World Report).(2)
"Bayer Diagnostics is looking forward to working with Inverness to help fight congestive heart failure with the BNP assay," stated Tom Warekois, Senior Vice President of Global Strategic Marketing for Bayer Diagnostics. "The BNP assay is an example of Bayer's ongoing commitment to improving life through scientific innovation. We hope to drive the benefits of BNP testing to patients and healthcare providers globally."
"We are very pleased to be able to work with Bayer in developing and producing point of care tests using BNP as a marker for congestive heart failure," stated Ron Zwanziger, CEO of Inverness. "Used in combination with our Urotensin marker, we believe that Inverness and Bayer will have a potentially strong position in the early diagnosis of congestive heart failure in both near patient and laboratory markets."
The second agreement grants Bayer an option to commercialize Inverness' proprietary Urotensin marker on its automated immunoassay systems worldwide. Preliminary evidence indicates that Urotensin, when used in conjunction with BNP, may be of significant value in improving the specificity of early diagnosis of congestive heart failure.
The third agreement calls for Inverness and Bayer to work together in developing an application of the Inverness Ischemia Modified Albumin (IMA(R)) test for worldwide use on Bayer's automated ADVIA(R) chemistry analyzer. IMA is a proprietary serum marker that assists in the early evaluation of acute coronary syndrome (ACS) prior to heart attack in patients presenting to hospital emergency departments with chest pain. There are over 6 million such visits each year in the United States alone with the number rising by about 10% a year.(3)
The final agreement grants Bayer non-exclusive rights to an Inverness hybridoma cell line capable of producing monoclonal antibodies against the envelope protein of the Hepatitis B virus (HBe). The agreement provides Bayer the right to use tests employing this monoclonal antibody on its automated immunoassay systems.
Bayer Diagnostics' BNP Assay
Bayer Diagnostics, in 2003, received FDA clearance for its fully-automated BNP test as an aid in the diagnosis of heart failure. The following year, Bayer Diagnostics received FDA clearance for two added claims-the prediction of survival in patients after myocardial infarction and assessment of heart failure severity in patients diagnosed with congestive heart failure. In May 2005, two additional claims received 510(k) clearance; in patients with acute coronary syndromes (ACS), the BNP assay, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.
Bayer Diagnostics licensed BNP directly from Shionogi Corporation in Japan. Bayer's in vitro diagnostic test for the quantitative determination of BNP is available for worldwide use on the Bayer ADVIA Centaur(R), the ACS:180(R) Immunoassay Systems and, pending FDA clearance, will be available on the Olympus AU3000i system.
About Bayer HealthCare, Diagnostics Division
Bayer HealthCare, Diagnostics Division (www.bayerdiag.com), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of laboratory testing, molecular testing and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology and women's health. Bayer HealthCare Diagnostics Division's global headquarters in the United States operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004. Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
About Inverness Medical Innovations
Inverness Medical Innovations is a leading global developer of in vitro diagnostic products and is presently exploring new opportunities for its lateral flow immunoassay and other proprietary technologies in a variety of professional diagnostic and consumer-oriented applications, including immunodiagnostics with a focus on cardiology, infectious disease and women's health. Inverness' new product development efforts, as well as its position as a leading supplier of consumer pregnancy and fertility/ovulation tests and rapid point-of-care diagnostics, are supported by the strength of its intellectual property portfolio. Inverness is headquartered in Waltham, Massachusetts. For more information about Inverness Medical Innovations, please visit our website at www.invernessmedical.com.
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) Maisel, RAPID MEASUREMENT OF B-TYPE NATRIURETIC PEPTIDE IN THE EMERGENCY DIAGNOSIS OF HEART FAILURE N Engl J Med 2002;347:161-7. (2) "Leading Heart and Heart Surgery Hospitals in the United States"; "America's Best Hospitals: The Honor Roll", July 28, 2003, U.S. News and World Report (3) Americanheart.org
Bayer HealthCareCONTACT: Marianne Flanagan of Bayer Diagnostics, +1-914-366-1825; or DougGuarino, +1-781-647-3900, or Chris Lindop, +1-781-314-4097, both ofInverness Medical Innovations
