Broad industry experience includes global development of sorafenib (Nexavar®)

ArQule, Inc. (Nasdaq: ARQL) today announced the appointment of Brian Schwartz, M.D., as chief medical officer effective July 14, 2008.

Dr. Schwartz brings to ArQule significant experience in oncology drug development in both the biotechnology and pharmaceutical industries. He was most recently senior vice president, clinical and regulatory affairs, and chief medical officer at Ziopharm Oncology, Inc., which he joined in 2006 and where he built and led clinical, regulatory, and quality assurance departments responsible for the development of new cancer drugs.

Prior to joining Ziopharm, Dr. Schwartz held a number of positions at Bayer Healthcare and Leo Laboratories. Over the past eight years, he has focused on oncology clinical development of novel cytostatic, cytotoxic and immunological agents, achieving awards of excellence from both companies. At Bayer, Dr. Schwartz was a key physician responsible for the global clinical development of sorafenib (Nexavar®) and led the clinical team through a successful Phase 3 trial in renal cell cancer, leading to U.S. Food and Drug Administration (FDA) approval. He has extensive regulatory experience working with the FDA’s Oncology Division, the European Medicines Evaluation Agency (EMEA), and numerous other health authorities. Dr. Schwartz was also responsible for U.S. clinical and regulatory activities, including Phase 4 studies and interactions with the National Cancer Institute and other oncology cooperative groups. He has broad experience in working with scientific advisory boards and international project teams, as well as in leading joint development projects with biotechnology companies. Dr. Schwartz received his medical degree from the University of Pretoria, South Africa, practiced medicine, and worked at the University of Toronto prior to his career in industry.

“Dr. Schwartz’ depth and breadth of oncology product development experience will help advance the development of our lead molecule, ARQ 197, a selective, small molecule inhibitor of the c-Met receptor tyrosine kinase, and our earlier-stage product candidates in an effective and timely fashion,” said Paolo Pucci, chief executive officer of ArQule. “His insights into state-of-the-art clinical operations, combined with his U.S. and international experience, will allow us to maximize the development opportunities for ARQ 197 so that the significant clinical and commercial potential of this product is realized.