Healthcare Industry News: alfimeprase
News Release - June 29, 2006
Nuvelo Expands Depth in Manufacturing and Development With Key Additions to Management TeamGregory Yedinak Joins Nuvelo as Vice President, Manufacturing and Process Sciences Ralph Zitnik Joins Nuvelo as Vice President, Development
SAN CARLOS, Calif., June 29 (HSMN NewsFeed) -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced the appointment of Gregory S. Yedinak as vice president, manufacturing and process sciences, and Ralph J. Zitnik, M.D., as vice president, development. Both join Nuvelo as members of the management team.
"Greg and Ralph join Nuvelo at an exciting time as we prepare to expand several of our development programs as well as our commercialization capabilities," said Michael D. Levy, M.D., senior vice president, research and development. "Greg's 20 years of experience in biopharmaceutical manufacturing will be invaluable as we move into commercial manufacturing with alfimeprase, and Ralph's long-standing experience in clinical development will be critical as we advance our alfimeprase and rNAPc2 programs, as well as our earlier stage programs such as NU206."
Mr. Yedinak joins Nuvelo from Amgen (formerly Abgenix) where he served most recently as vice president, manufacturing, facilities and engineering. In that position, he was responsible for directing the clinical and commercial manufacturing facilities and engineering operations at sites in Fremont, California and Vancouver, British Columbia, and played a pivotal role in managing the Chemistry Manufacturing and Controls section of multiple U.S. and global regulatory submissions, including the Biologics License Application for Abgenix's lead product candidate, panitumumab. Previously, he spent 15 years at Genentech, where he had various roles in the manufacturing of more than 20 marketed products and product candidates. He received a bachelor's degree in biological sciences from the University of California, Irvine.
Dr. Zitnik joins Nuvelo after four years at Amgen, where he served most recently as senior director and therapeutic area head for osteoporosis, responsible for oversight of an ongoing global registrational clinical development program. Earlier in his tenure at Amgen he was global development team leader for dermatology and director in the inflammation therapeutic area, where he designed and implemented a clinical program that led successfully to U.S. and European approval for the use of EnbrelŪ (etanercept) in psoriasis. From 2000 to 2002, he was medical director, clinical development at Immunex, where he led clinical research programs in rheumatology, asthma and dermatology, until Immunex was acquired by Amgen in 2002. Prior to that, he held management positions in clinical research at Pfizer and at Bayer, where he was responsible for cardiovascular, pulmonary and oncology studies. Before joining the industry, Dr. Zitnik completed his residency in internal medicine at Yale-New Haven Hospital, then trained as a fellow and was subsequently a member of the faculty in pulmonary and critical care medicine at Yale University.
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo's development pipeline includes three acute cardiovascular programs: alfimeprase, a direct-acting thrombolytic in four Phase 3 clinical trials for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex which recently completed Phase 2 clinical development in acute coronary syndromes; and a thrombin inhibiting aptamer for anticoagulation during medical procedures. Nuvelo is also advancing an emerging oncology pipeline, which includes NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis, as well as rNAPc2 for potential use as a cancer therapy. In addition, Nuvelo expects to leverage its expertise in secreted proteins and cancer antibody discovery to further expand its pipeline and create additional partnering and licensing opportunities.
Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements" regarding the timing and progress of Nuvelo's clinical programs, the anticipated commercial launch of Nuvelo's lead product candidate and the anticipated commencement of commercial manufacturing of Nuvelo's lead product, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo's recent annual report on Form 10-K for the year ended December 31, 2005 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
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