NEWS OF THE W EEK
BR IG HA M YOU N G U
PFIZER SETTLES CELEBREX LAWSUIT INTELLECTUAL PROPERTY: Drug firm logs a $450 million charge
Simmons
W
EEKS BEFORE a scheduled trial, Pfizer and
Brigham Young University have settled a sixyear-old lawsuit brought by the university and Daniel L. Simmons, a BYU chemistry professor, over the cyclooxygenase-2, or COX-2, inhibitor that is the active ingredient in Pfizer’s Celebrex, the blockbuster painkiller. Although the terms were not made public, Pfizer noted a $450 million charge in connection with the settlement in its first-quarter earnings report. The university is reported to have sought 15% royalties on sales of Celebrex to date, or close to $10 billion, but a jury could have awarded much more in punitive damages and interest. The suit contended that Simmons discovered the COX-2 enzyme and in 1991 brought the discovery to Monsanto’s Searle drug unit, which Pfizer later acquired. It claimed that BYU and Monsanto entered a research agreement to develop a COX-2 inhibitor for inflammation under the direction of Simmons.
TEACHING OLD DRUGS NEW TRICKS NIH
RESEARCH: NIH program aims to find new uses for promising compounds shelved by pharma
U HHS
Collins
Sebelius
NDER A PILOT PROGRAM announced by NIH
last week, dozens of drug compounds that have advanced to clinical studies but are no longer being pursued for their original indication will be available to NIH-funded researchers. The program provides research grant support and template agreements with the pharmaceutical firms that own the compounds. The pilot program—Discovering New Therapeutic Uses for Existing Molecules—is the first major endeavor of the National Center for Advancing Translational Sciences (NCATS), which was established this year with a budget of $30.9 million. The collaborative program initially involves three pharmaceutical partners—Pfizer, AstraZeneca, and Eli Lilly & Co.—which have agreed to make 24 compounds available. “To accelerate our nation’s therapeutic development process, it is essential that we forge strong, innovative, and strategic partnerships across government, academia, and industry,” Department of Health & Human WWW.CEN-ONLIN E .ORG
6
BYU contended that the agreement ensured the university profits from patentable results but that Monsanto fraudulently terminated the deal so it could secretly develop a COX-2 inhibitor on its own. Searle went on to introduce Celebrex, the first COX-2 inhibitor, in 1999. BYU’s complaint described other lawsuits surrounding the COX-2 enzyme in which Simmons was asked to testify as an expert witness. These included Searle’s suit against Merck & Co. over the latter’s Vioxx painkiller and a suit brought by the University of Rochester against Searle contending a patent violation. In the process, BYU’s suit contended, Simmons received information from Monsanto documents contradicting the company’s prior statements regarding research on COX-2 inhibitors. The university said the contradictions indicate that Monsanto fraudulently concealed wrongdoing. As part of the settlement, BYU will endow a Dan Simmons Chair in recognition of Simmons’ lifelong work and contributions toward advancing human health in areas such as oncology and Alzheimer’s disease. BYU issued a statement asserting that it is pleased with the outcome. Simmons did not return a call for comment. Pfizer issued a press release stating, “We are pleased to resolve this matter and the uncertainty of litigation and to be in a position to support Dr. Simmons’ research efforts at BYU.” —RICK MULLIN
Services Secretary Kathleen Sebelius said at the May 3 rollout of the program. She added that this pilot is effectively the “crowdsourcing” of pharma compounds to the brightest drug development minds in the country. The compounds from the pharmaceutical partners are about halfway through the development pipeline, having been studied for five to seven years with tens of millions of dollars invested in them. They have cleared the safe-for-human-use step. Interested researchers can begin applying for NCATS grants beginning next month. The applications will be peer reviewed. NCATS will dedicate $20 million to the program in fiscal 2013 to fund awards. NIH and NCATS are playing a matchmaking role in this process, explained NIH Director Francis S. Collins at the rollout. The goal is to create new opportunities for drugs that failed their intended use, a redirection that’s happened serendipitously. “We must generate more success stories in a systematic way,” he said. For their part, the drug firms have committed to supply researchers with the compounds and related data. “Pfizer has a rich history of partnering with the academic and public sectors to discover and develop innovative medicines,” said Rod MacKenzie, head of Pfizer PharmaTherapeutics R&D. “We believe that participating in this unique program, and making wellresearched molecules available to NIH’s broad network of researchers, is another important step in advancing a vibrant biomedical ecosystem.”—SUSAN MORRISSEY
MAY 7, 20 12
