COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

WASHINGTON, D.C. – September 10, 2013 – The COPD Biomarkers Qualification Consortium (CBQC) announced today at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, "To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them."

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, "COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes."

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, "The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them."

The CBQC Fibrinogen Working Group is composed of the following members:

• Bruce Miller, industry co-chair, GlaxoSmithKline
• Ruth Tal-Singer, GlaxoSmithKline
• Mike Lowings, GlaxoSmithKline
• Ubaldo Martin, AstraZeneca
• Jeff Snyder, Boehringer-Ingelheim
• Kay Tetzlaff, Boehringer-Ingelheim
• Armin Furtwaengler, Boehringer-Ingelheim
• Nicholas Locantore, GlaxoSmithKline
• Nancy Leidy, Evidera
• Amber Martin, Evidera
• Jason Simeone, Evidera
• David Mannino, academic co-chair, University of Kentucky
• Stephen Rennard, University of Nebraska
• David Lomas, University College London, U.K.
• Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
• Graham Barr, Columbia University
• Debora Merrill, COPD Foundation