Uppsala, Sweden and Copenhagen, Denmark, August 22, 2011
Phadia AB and Biomonitor A/S announced today a collaboration in the field of immunogenicity testing and monitoring of patients treated with biopharmaceutical drugs.
"The addition of BioMonitor’s iLite technology to our portfolio makes us the most complete supplier of solutions for Anti-Drug Antibody (ADA) testing," says Hans Johansson, Head of Phadia's Development Business. "We can now offer ADA testing services and products covering preclinical research through to patient monitoring in the clinic for most clinically relevant ADA tests."
Immunogenicity and Patient Monitoring
In biotherapeutic drug development, immune response towards the drug is a growing concern. Authority Gudelines require data on all immune responses, and call for early immunogenicity testing of all biological drugs in development. For drugs in the clinic, biotherapeutic drug monitoring is a component of personalizing medical treatment, where the individual patient can be regularly tested for bioactive drug levels and the possible formation of antibodies that defeat the drug action. Biopharmaceuticals are expensive and, when they are administered for chronic diseases, it is essential to monitor the patient’s response to the drugs in order to optimize patient care and control disease-related pathologies.
Phadia AB, a world leader in Allergy and Autoimmunity diagnostics since over 40 years, has recently taken a strategy to commercialize its antibody measurement technologies into the field of Anti- Drug Antibody (ADA) detection.
Phadia’s clinical laboratory platform is in use in over 3,000 clinical labs around the world. The existing platform can be easily adapted for patient monitoring of ADA levels in patients treated with biopharmaceutical drugs.
Biomonitor’s work and research place it among the leaders in the world in cell-based assays and monitoring patients on biotherapeutic drugs using proprietary as well as other assays. In the past eight years, Biomonitor has been actively involved in the Danish Multiple Sclerosis Group, monitoring interferon-beta-treated MS patients. The company has also monitored drug levels and neutralizing ADAs in patients with rheumatoid arthritis and Crohn’s disease treated with TNF-alpha antagonists.
The basis of the partnership is Biomonitor’s iLite™ technology. This proprietary technology combines state-of-the-art reporter gene assay methodology with division-arrested, cryopreserved cells, which can respond in a sensitive and reliable manner to report biotherapeutic drug activity in patient serum and can measure levels of neutralizing antibodies. The Biomonitor iLite™ cells are manufactured and tested under the strictest quality standards (ISO 13485 Certification) and has been validated in several laboratories.
Dr. Arsalan Kharazmi, CEO of Biomonitor, stated: "We are pleased and enthusiastic about our collaboration with Phadia. It allows Biomonitor to take advantage of our many years of experience in cell-based assays and in monitoring patients and to employ our patented iLite™ reporter gene technology globally with the help of an outstanding diagnostic company. We are convinced that biotherapeutic drug monitoring will increase treatment efficacy, save money for the health care systems, and result in better patient care."
Hans Johansson, Head of Phadia Business Development, stated: "In this important new market, our ImmunoCAP platform creates great clinical value for clinicians. Cell-based technologies such as iLite are an essential component for developing the field further. We are very excited about adding the iLite technology to our offering to clinics as well as to pharmaceutical companies for improving submissions of new biological drugs".
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Biomonitor A/S is a privately held Danish company founded in 2003 and funded by Sunstone Capital, Denmark. The company is among the leaders in developing innovative, reliable assay technologies and incorporating these tests into large and comprehensive patient-monitoring programs. In addition to monitoring programs for MS patients, the company offers laboratory-testing services for patients on anti-TNF drug therapy (both circulating levels of drug and detection of ADAs, and, as a specialized CRO, supports the pharma and biotech industry in their drug-development programs for many classes of biological drugs. Biomonitor Limited is Biomonitor A/S’s wholly owned subsidiary located in Galway, Ireland and is an ISO-certified manufacturing facility.
Phadia develops, manufactures and markets complete blood test system to support the clinical diagnosis and monitoring of allergy, asthma, and autoimmune disease. Our mission is to dramatically improve the management of allergy, asthma and autoimmune diseases by providing healthcare professionals with superior diagnostic technologies and clinical expertise. We supply more than seven out of ten allergy laboratory tests worldwide and four out of ten autoimmunity tests to laboratories throughout Europe. For more information please visit www.phadia.com