Healthcare Industry News: diabetic foot ulcers
News Release - July 20, 2011
Agennix Hires Christine Boisclair as Senior Vice President of Global Regulatory AffairsPLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Healthcare Sales & Marketing Network) - Agennix AG (Frankfurt:AGX ) today announced the appointment of Christine Boisclair as Senior Vice President, Global Regulatory Affairs, reporting to Dr. Rajesh Malik, Chief Medical Officer. In this position, Ms. Boisclair will lead all global regulatory, quality and compliance activities for Agennix, including regulatory filings for talactoferrin.
Rajesh Malik, M.D., Chief Medical Officer, said, "I am very pleased to welcome Christine Boisclair to Agennix. She has a strong track record of getting drugs approved in both Europe and the U.S., including a drug for non-small cell lung cancer. Her extensive expertise in overseeing novel therapies through the regulatory review process will be invaluable as we advance talactoferrin through development and prepare for a potential regulatory filing if the FORTIS-M trial is positive."
Ms. Boisclair has over twenty years of U.S. and European regulatory affairs experience, covering both drugs and biologics in a variety of therapeutic areas, including oncology and anti-infectives. She joins Agennix from OSI Pharmaceuticals, Inc., where she worked for over ten years in positions of increasing responsibility, most recently serving as Vice President, Regulatory Affairs. At OSI, she built up the regulatory affairs department and served as the regulatory lead for the successful New Drug Application (NDA) for Tarceva® (erlotinib) in non-small cell lung cancer (NSCLC), as well as the subsequent supplemental NDAs for pancreatic cancer and NSCLC maintenance. Prior to OSI, she worked at several biotechnology and pharmaceutical companies, including Genzyme Corporation, GD Searle & Co. and Glaxo Group Research. She holds a Bachelor of Science Honors Degree in Biochemistry from York University, York, England.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, an oral immunotherapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer and in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and a Phase II/III trial with talactoferrin in severe sepsis is underway. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Agennix™ is a trademark of the Agennix group.
Tarceva® is a registered trademark of OSI Pharmaceuticals, Inc.
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