J&J to take short break in enrollment of subjects in trial of arthritis drug
Thursday, December 07, 2006
Johnson & Johnson yesterday confirmed a hiccup in its clinical trials for golimumab, a treatment for rheumatoid arthritis.
The New Brunswick health-care giant has stopped enrollment in some Phase III trials because one of its vendors has been unable to distribute the drug in a timely way to some test sites.
The problem has nothing to do with manufacturing or safety is sues, said Michael Parks, a spokesman for Centacor, the Johnson & Johnson subsidiary that is developing the drug.
"We intend to resolve the issue as quickly as possible," Parks said, adding that enrollment could re sume as early as mid-January.
Because the company is ahead of schedule in enrollment for the clinical trials, there will be no im pact on regulatory timetable, Parks said.
The progress of golimumab is important for two other New Jersey companies. Schering-Plough, based in Kenilworth, has marketing rights for the drug outside of the United States. And Medarex, a Princeton biotechnology company that licensed some of its antibody technology to J&J, is in line for payments tied to development milestones, as well as royalties.
Prudential Equity analyst Timothy Anderson estimates Schering- Plough alone could reap $300 million in sales from the drug in 2010.
nj.com |
