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Prometheus launches new monitoring test to help guide inflammatory bowel disease management

PROMETHEUS Anser™ IFX designed to help identify potential causes for loss of treatment response among IBD patients using infliximab


San Diego, July 31, 2012 – Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced today the market launch of its proprietary new generation monitoring test, PROMETHEUS Anser IFX. This test measures drug (infliximab) and drug antibody levels in one sample among inflammatory bowel disease (IBD) patients using infliximab – helping physicians identify potential causes for loss of treatment response and helping to guide patient management decisions. This is the first commercial test utilizing Prometheus’ proprietary homogenous mobility shift assay (HMSA) platform technology. Prometheus intends to use this platform for subsequent introductions of additional tests targeted to other biologic agents being used to treat a variety of autoimmune diseases.

The Crohn’s and Colitis Foundation of America estimates that approximately 1.4 million Americans suffer from IBD. Approximately 50% of IBD patients using infliximab may eventually experience a loss of treatment response during their treatment. For some patients, this loss of treatment response may be the result of insufficient infliximab levels. For others, the loss may be due to the development of antibodies to infliximab (ATI). If the loss of treatment response is due to the development of ATI, increasing the infliximab dose – the most common first step for physicians – may be less effective than switching to another treatment agent. PROMETHEUS Anser IFX test was verified with more than 3,000 IBD clinical patient samples.

The need for PROMETHEUS Anser IFX is high, and its availability marks the latest milestone in our continuing commitment to significant advancements in personalized medicine for gastroenterologists, patients and healthcare providers,” said Joseph M. Limber, President and Chief Executive Officer of Prometheus. “PROMETHEUS Anser IFX provides significant value to the IBD patient using infliximab and his or her treating physician – potentially saving time and effort in guiding treatment decisions when response to infliximab is lost.”

About IBD

IBD, including Crohn’s disease and ulcerative colitis, is a chronic inflammatory condition of the intestinal tract. Symptoms of the disease may include diarrhea, abdominal pain, fever and rectal bleeding. Patients may require long-term medical care, including hospitalizations, surgeries and therapeutics. The condition can be difficult to diagnose and manage clinically while consuming a substantial amount of healthcare resources in terms of physician time, procedures and medications.

About Infliximab

Infliximab belongs to a class of drugs called tumor necrosis factor (TNF) blockers. TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to autoimmune diseases. In addition to being approved for ulcerative colitis, infliximab is approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children 6 years and older, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque psoriasis in adults. The drugs in this class include Remicade® (infliximab), Enbrel® (etanercept), Humira® (adalimumab), Cimzia® (certolizumab pegol) and Simponi® (golimumab).

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus became part of Nestlé Health Science in July 2011. Prometheus’ corporate offices are located in San Diego, California. For more information about Prometheus, please visit www.prometheuslabs.com.

REMICADE is a registered trademark of Centocor Ortho Biotech Inc.
HUMIRA is a registered trademark of Abbott Laboratories.
CIMZIA is a registered trademark of the UCB group of companies.
ENBREL is a registered trademark of Immunex Corporation
SIMPONI is a registered trademark of Johnson & Johnson



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