Healthcare Industry News: sulodexide
News Release - February 15, 2008
Keryx Biopharmaceuticals Announces Additions to Management TeamKey Hires in Quality Operations and Medical Affairs
NEW YORK, Feb. 15 (HSMN NewsFeed) -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) today announced that Lou DeBergalis has joined the Company as Vice President, Quality Operations. Keryx also announced that Eric Grossman, MD, will join the Company later this month in the role of Vice President, Medical Affairs. Both Mr. DeBergalis and Dr. Grossman will report directly to Michael S. Weiss, Chief Executive Officer.
As Vice President, Quality Operations, Mr. DeBergalis will assume overall strategic and operational responsibility for all Quality Operations (clinical, non-clinical and manufacturing), including both quality control and quality assurance.
Mr. DeBergalis joins Keryx following his retirement from Pfizer Inc. in July 2007 as Vice-President Quality Operations - Europe/Ireland/Singapore, responsible for the operational, administrative, and regulatory aspects of quality in Pfizer's manufacturing sites in those geographic areas. During his 36 years in the Pfizer organization, Mr. DeBergalis held roles of increasing responsibility in both its Global Manufacturing and Quality Control Divisions in Pfizer's New York City office, as well as manufacturing operations in Puerto Rico, Indiana, and Brooklyn, New York as well as global responsibility for outsourced contract operations. Mr. DeBergalis received a B.S. from Fordham University in chemistry, as well as graduate degrees in chemistry and business from Canisius College, and Indiana State University, respectively.
As Vice President, Medical Affairs, Dr. Grossman will build and manage the Medical Affairs and Medical Information functions. Key components of this role include creation of phase 3 and 4 clinical development strategy and management of clinical trials; partnering with Commercial Operations to craft optimal medical commercialization strategy and to ensure expert medical support of new product commercialization; starting a medical information unit to respond to physician and patient inquiries, and development of medical liaison support.
Most recently, Dr. Grossman was Medical Director of the New York Organ Donor Network. Prior to that, Dr. Grossman was at Pfizer Inc. for over 8 years during which time he served as Medical Group Leader, Cardiovascular, Metabolic and Sexual Health. In that role he had oversight of clinical trials, regulatory, educational and promotional activities for some of the biggest pharmaceuticals at Pfizer, including Norvasc and Viagra.
Dr. Grossman, a board-certified nephrologist, received his bachelor's degree with honors from the University of Chicago and his medical degree from the Pritzker School of Medicine at the University of Chicago. After completing his internal medicine residency at Tufts-New England Medical Center in Boston, Dr. Grossman completed a research and clinical fellowship in nephrology at Brigham and Women's Hospital and Harvard Medical School. Dr. Grossman has had faculty appointments at Harvard Medical School, University of Rochester School of Medicine and NYU Medical School.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is Sulonex(TM) (sulodexide oral gelcap), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, iron- based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end-stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401, a novel, first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Some of the statements included in this press release anticipating future clinical and business prospects for our lead drug candidate Sulonex, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward- looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the results of the Phase 3 study for Sulonex could be inconclusive or negative; even if we receive positive results from the Phase 3 study for Sulonex, we may not be able to finalize the NDA before year end for various reasons including the completion of necessary non- clinical studies; the completion of manufacturing preparations; or other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
Source: Keryx Biopharmaceuticals
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