By Nathalie Tadena November 8, 2013, 8:40 a.m. ET
Pfizer Inc. (PFE) said its organ-transplant drug Rapamune drug didn’t meet its primary endpoint in a late stage study of kidney transplant patients.
The Phase 3B/4 study evaluated kidney transplant patients who transitioned from tacrolimus-based therapy to Rapamune three to five months after transplant. Pfizer said there was no statistically significant difference in renal function improvement between patients who continued receiving TAC and those who switched to Rapamune.
There were 256 subjects in the open-label, randomized study. The study also evaluated the safety of Rapamune, and Pfizer noted the adverse events observed in the study were consistent with the known safety profile for the drug.
In the U.S., Rapamune is used to inhibit organ-transplant rejection in kidney transplant patients who are at least 13 years old.
Pfizer has been grappling with the loss of market exclusivity for cholesterol-lowering drug Lipitor since 2011, and more recently has experienced generic competition for erectile-dysfunction pill Viagra in Europe.
PfizeR is facing continued sales pressure from generic competition for top-selling drugs, which contributed to a 19% profit decline for the third quarter. The drug maker has also signaled its research-and-development spending cuts would ease.
Shares were off by seven cents to $30.74 in premarket trading. The stock is up 23% year-to-date.
Write to Nathalie Tadena at email@example.com
via Pfizer’s Rapamune Doesn’t Meet Primary Endpoint in Study of Kidney Transplant Patients – WSJ.com.