Thursday, June 16, 2011

Cubist sees promising Phase 2 data on antibiotic candidates

By Lori Valigra, Mass High Tech correspondent

Cubist Pharmaceuticals Inc. of Lexington said recently completed Phase 2 studies of two antibiotic drug candidates – CXA-201 for complicated intra-abdominal infections (cIAI) and CB-183,315 for Clostridium difficile-associated diarrhea (CDAD) – showed positive results.

Based on the data, the company plans to start Phase 3 studies of CXA-201 for indications in both cIAI and complicated urinary tract infections (cUTI) by the end of 2011, according to a press release. In January, the company said that if it remains on track with its clinical plan for CXA-201 and is successful, it could file for a new drug application for the two indications by the end of 2013.

The company said it will decide on whether or not to start Phase 3 studies of CB-183,315 by year-end 2011. 

The positive results from the two trials are significant milestones for Cubist’s pipeline, said Steven Gilman, executive vice president of R&D. He added that there remains a large and growing need for new and better antibiotics worldwide.

The company today also praised Rep. Phil Gingrey (R-Ga.) for introducing the Generating Antibiotic Incentives Now (GAIN) bill of 2011. The legislation aims to help restore the antibiotic development pipeline to target emerging multi-drug-resistant (MDR) bacteria, a growing health threat. The bi-partisan legislation calls for specific economic and market incentives to attract pharmaceutical companies to develop new antibiotics to treat the infections caused by MDR bacteria.

“The antibiotic development pipeline is in danger of running dry. Without policies to reverse this market failure, our public health system is at risk of increased treatment costs in the vicinity of $20 billion a year. In addition, our national security can be vulnerable to a bioterrorist attack using antibiotic-resistant organisms,” Cubist President and CEO Michael Bonney said in a statement. A report in Clinical Infectious Diseases found that as of 2004, there were only five antibiotics in the R&D pipeline compared to 67 drugs in development for cancer, 33 for inflammation/pain, 34 for metabolic/endocrine disorders, and 32 for pulmonary disease.

The company’s stock (Nasdaq: CBST) was up 4.6 percent or $1.56 over yesterday’s close to $35.25 at 1:15pm EDT on Thursday.