SAN FRANCISCO--- Novacea Expands Management Team With Key Appointments in Clinical Development, Regulatory Affairs and Business Development


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SAN FRANCISCO--- Novacea Expands Management Team With Key Appointments in Clinical Development, Regulatory Affairs and Business Development
7/6/2005 @ 2:56 PM print this article - email to a friend - join our eNewsletter

Novacea, Inc., announced today additions and promotions to its management team aimed at enhancing the Company's clinical and regulatory capabilities and in recognition of strategic contributions in business development. Fong Wang Clow, D.Sc., joins the Company as senior vice president of development and Charles J. Democko joins as vice president of regulatory affairs. Paul Westberg has been promoted to vice president of business development. "Novacea is pleased to welcome Dr. Wang Clow and Mr. Democko to the team. Fong's experience in all stages of clinical development, especially Phase 3 programs and preparations for product approvals, will be critical to Novacea as we move our lead product candidate, DN-101, closer to registration," Brad Goodwin, chief executive officer of Novacea said, "In regulatory affairs, Chuck brings extensive expertise in FDA communications and the preparation of successful regulatory submissions, experience that will prove valuable as we formulate strategies for commercial registration." DN-101 is currently in clinical testing for advanced prostate cancer and non-small cell lung cancer. Robust results from Novacea's Phase 2/3 clinical study of DN-101 in advanced prostate cancer, demonstrating a significant survival benefit for patients receiving DN-101 plus Taxotere(R) versus Taxotere plus placebo were presented at the American Society of Clinical Oncology (ASCO) conference in May of this year. The Company's second product banoxantrone (AQ4N), is a tissue-targeting cytotoxic prodrug. Banoxantrone is currently undergoing Phase 1 clinical testing. "The well deserved promotion of Mr. Westberg recognizes his significant contributions to our in-licensing and business development efforts that provide the platform for Novacea's future growth," Mr. Goodwin continued. "Paul was key to our successful acquisition of North American rights for banoxantrone (AQ4N), and he is currently evaluating additional opportunities that fit our vision to prolong life and improve the safety, convenience and clinical benefit of current cancer treatments." Dr. Wang Clow - Senior Vice President, Development Prior to joining Novacea, Dr. Wang Clow served as an independent consultant, leveraging her drug development experience to pharmaceutical and biotechnology companies in oncology, cardiology and infectious diseases. Before that, she served as project team leader and senior director of clinical affairs at Theravance, Inc., where she guided regulatory, marketing and clinical efforts. Previously, Dr. Wang Clow spent several years at Genentech, Inc., where she served as clinical team leader, principal biostatistician and associate director and successfully organized or was a key leader in three new drug applications, including: TNKase(TM) for the treatment of acute myocardial infarction; Activase(R) for both myocardial infarction and stroke; and the FISH (fluorescence in situ hybridization) test submission team for Herceptin(R) for breast cancer. She also served as a biostatistician at Syntex Laboratories, a research assistant at the Dana-Farber Cancer Institute, and a lecturer at the Wuhan Medical University. Dr. Wang Clow holds a Doctor of Science degree from Harvard University, is the author of numerous publications, and a recipient of various awards, and is a coinventor on a patent. Charles J. Democko - Vice President, Regulatory Affairs Mr. Democko has spent more than 27 years in pharmaceutical research and development, where he has managed regulatory requirements for investigational new drugs and commercial products. Mr. Democko's areas of therapeutic experience from past projects include: cardiovascular, anti-infective, pain management, allergies/asthma, AIDS, and dermatology. Most recently, Mr. Democko served as vice president of development at PharmacoFore and before that as vice president of regulatory affairs at Connetics, where he led the New Drug Application (NDA) development team for Velac(R) Gel, an investigational new drug formulation for treating acne. Earlier in his career, Mr. Democko held roles of increasing responsibility in regulatory affairs at Theravance, Inc., Elan Corporation, plc, and Genentech. While at Genentech, Mr. Democko participated in the rapid registration of Activase for stroke. Mr. Democko received his undergraduate degree in microbiology at The Ohio State University and has completed classes in MBA studies at the Graduate School of Business, San Francisco State University. Paul Westberg - Vice President, Business Development Paul Westberg joined Novacea in 2002 as Director of Business Development where his duties included responsibility for heading the Company's oncology product licensing activities. Mr. Westberg has over 10 years of experience in the biopharmaceutical industry, with particular emphasis in business development and finance. Previously, he was Director of Business Development for Deltagen, Inc., where he was a key contributor in the company's evolution to a fully integrated discovery company. Prior to Deltagen, he held managerial positions in business development at Collabra Pharma and financial planning at Aviron. Mr. Westberg also held positions of increasing responsibility at Genentech as Manager of Project Finance and of Financial Planning and Analysis and served as an industry consultant advising diagnostic, pharmaceutical and gene therapy companies on valuation, technology assessment and commercialization issues. Mr. Westberg holds a bachelor's degree in applied mathematics from the University of California, San Diego and a master's degree in business administration from the Haas School of Business at the University of California at Berkeley. About Novacea Novacea is a privately held biopharmaceutical company focused on the licensing, development and commercialization of novel products to revolutionize the treatment of cancer. The Company currently has two products in clinical development: DN-101 and banoxantrone (AQ4N). DN101 recently completed a Phase 2/3 clinical study in advanced prostate cancer and is also being evaluated in a Phase1 / 2 study in advanced non-small cell lung cancer. Banoxantrone, a tissue-targeting cytotoxic prodrug, has shown preclinical activity in both solid tumors and lymphoid malignancies and currently is being tested in a Phase 1 clinical trial to determine safety and dosing. The Company plans to expand its product portfolio by in-licensing other compounds that leverage its development expertise in oncology and hematology. For more information, visit www.novacea.com.