Celebrex clinical investigator Lee Simon, MD, will take over as director of FDA's Division of Anti-Inflammatory, Analgesic & Ophthalmic Drug Products Nov. 19.

An associate professor of medicine at Harvard Medical School, Simon was involved in the clinical trials supporting the NDA for Pharmacia/Pfizer's COX-2 inhibitor Celebrex (celecoxib). He was also a principal investigator and a lead author of the Celecoxib Long-term Arthritis Safety Study.

Simon currently oversees all clinical rheumatology research at Harvard's Beth Israel Deaconess Medical Center.

Simon replaces Acting Director Jonca Bull, MD. The Division's last permanent director, Karen Midthun, MD, left to head the Center for Biologics Evaluation & Research Office of Vaccines Research & Review in September 2000 (¹ Also see "FDA Vaccines Office Head Midthun Joins From Analgesic Division" - Pink Sheet, 9 October, 2000.).

Simon, 50, has been on the Harvard faculty since 1981, and first joined the university as a research fellow in 1978. He received his undergraduate degree from Loyola College in Baltimore in 1972 and his medical degree from the University of Maryland School of Medicine in 1976. He did two years of postgraduate training at Johns Hopkins.

Simon has served as a consultant to Lilly, Forest and Aventis, as well as to Pharmacia/Searle. In addition to working with Searle on the COX-2 inhibitor development, he participated in the development of the diclofenac/misoprostol combination Arthrotec.

As head of the rheumatology research program, Simon has overseen trials for many other agents, including a Phase II study of Lilly's LY333013 for rheumatoid arthritis; a Phase III trial of Proctor & Gamble's Actonel (risedronate) for osteoarthritis of the knee; a Phase II trial of Bristol-Myers Squibb's CTLA-4 for RA; and a Phase I/II trial of Bristol's anti-CD 40 for RA. He has also overseen studies involving La Jolla Pharmaceuticals' LJP 394 (abetimus) for lupus and a Novartis COX-2 inhibitor.

Simon is familiar with the FDA side of the drug development process as well. He served as a member of FDA's Arthritis Advisory Committee from 1994-98 and continues to serve as a consultant to the committee. Simon has also served as a consultant to the Division of Drug Marketing, Advertising & Communications as well as to the Gastrointestinal Drugs and Orthopedic Devices Advisory Committees.

Simon's research background with COX-2 inhibitors makes him an expert in one of the highest profile classes of drugs handled by the analgesics division.

However, because of his involvement in the development of Celebrex, he will be recused from decisions regarding COX-2 inhibitors for at least a year, and potentially longer for decisions related specifically to the Pharmacia drug.

FDA will be reviewing several COX-2 inhibitors over the next few years. Pharmacia/Pfizer's second-generation COX-2 valdecoxib was submitted in January; Simon oversaw a Phase III trial of the agent at Harvard. Pharmacia's NDA for parecoxib, an injectable prodrug of valdecoxib, is also pending. The company plans to respond to a July 13 "not approvable" letter with new data in 2002. Merck completed Phase III trials for its follow-on COX-2 etoricoxib in April and plans to file late this year. Novartis plans to file for COX-189 in 2002.

FDA also has pending supplements from Pharmacia and Merck (for Vioxx) seeking GI superiority claims in labeling. FDA gave the applications "approvable" status in April. An FDA advisory committee recommended that data on both GI events and cardiovascular risks be included in any labeling change (² [A#00630070000]).

One of the issues debated in the context of the COX-2 safety supplements is the potential trade-off between GI and cardiac safety. A "Special Communication" in the Journal of the American Medical Association by Cleveland Clinic researcher Eric Topol, MD, et al., found that a meta-analysis of Vioxx and Celebrex trials suggests an adverse cardiovascular effect with the COX-2s.

Pharmacia's handling of the data from the CLASS trial has received attention in lay media reports: JAMA maintains that when the company submitted six-month Celebrex data for publication, it did not tell the journal about 12 month data that had been collected. The six-month data were published in September 2000. Pharmacia says it is pursuing publication of the full 12-month data (³ Also see "Pharmacia To Publish Full 12-Month Data From CLASS Study Of Celebrex" - Pink Sheet, 20 August, 2001.).

FDA Anti-Inflammatory Division Director Will Be Celebrex Investigator Simon

More from Archive

More from Pink Sheet