>>Cubist Pharmaceuticals to End Development of CB-500,929
Decision follows review of Phase 2 top line results
Press Release Source: Cubist Pharmaceuticals, Inc. On Wednesday March 31, 2010, 4:00 pm
LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST - News) today announced that it plans to stop investing in the clinical development of CB-500,929 (ecallantide) as a therapy to reduce blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass. The company made this decision after reviewing top line efficacy and safety data from the CB-500,929 Phase 2 CONSERV™ 1 and CONSERV 2 trials. This decision does not impact the 2010 R & D cost guidance announced by the company in January 2010 as the guidance did not include costs for potential development of CB-500,929 beyond the CONSERV trials.
Top Line results
CONSERV 1: This study treated 249 patients undergoing primary Coronary Artery Bypass Graft (CABG) Surgery—while on cardiopulmonary bypass (CPB). This patient population was considered to be at a relatively low risk of bleeding complications in comparison to the CONSERV 2 population. Three doses of CB-500,929 (approximately 5, 25 or 75 mg depending on a patient’s weight and time on bypass) were evaluated vs. placebo. The results for this trial showed no improvement in blood loss (measured by the need for transfusion of blood and blood products) vs. placebo for any of the three doses studied. CONSERV 1 results showed similar safety results in patients who received study drug and those who received placebo.
CONSERV 2: This study treated 218 patients undergoing cardiac surgery while on CPB for procedures including repeat sternotomy, CABG + valve replacement or more than one valve replacement. This patient population was considered to be at a higher risk of bleeding complications than those undergoing a primary CABG procedure. In CONSERV 2, a dose of approximately 75 mg of CB-500,929 was studied vs. tranexamic acid as a comparator. The results of this trial also showed no treatment benefit for the CB-500,929 group relative to the comparator arm. A statistically significant higher rate of mortality was observed in patients in the study arm relative to those treated with tranexamic acid. This imbalance in mortality was observed by the Data Safety Monitoring Board late last year, and led Cubist to end enrollment in the CONSERV 2 trial early — see December 3, 2009 news release here. At that time, the company had also decided to end enrollment early in CONSERV 1 as a precaution although there was no imbalance in mortality observed in the CONSERV 1 results.
Given the decision by Cubist to end its development of CB-500,929, Cubist intends to terminate the 2008 agreement with Dyax under which Cubist in-licensed development and commercialization rights to CB-500,929 for surgical indications in the U.S. and the EU in accordance with the terms of the agreement.
Cubist has scheduled a conference call for 5:00 p.m. ET today to discuss the information in this news release.
******************CONFERENCE CALL & WEBCAST INFORMATION******************
Cubist will host a conference call and live audio webcast to discuss its decision
to end development of CB-500, 929 (ecallantide).
WHEN: Wednesday, March 31, 2010 at 5:00 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: 877-407-8289
LIVE INTERNATIONAL CALL-IN: 201-689-8341
24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853
24 HOUR REPLAY INTERNATIONAL: 201-612-7415
REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK):
ACCOUNT #: 351 CONFERENCE ID #: 348546
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
www.cubist.com
Replay will be available for 30 days via the Internet at www.cubist.com<<
snip
DYAX, CBST not showing much reaction, at least, not yet. Market apparently expected even less than I thought (which wasn't much).
Cheers, Tuck |
