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(12.17.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference

(11.25.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at the 20th Annual Piper Jaffray Health Care Conference

(11.10.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Reports Positive Data from its North American Phase 3 CDI Study of OPT-80

(11.5.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Reports Third Quarter 2008 Financial Results

(10.29.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at Oppenheimer Annual Healthcare Conference

(10.20.2008) SAN DIEGO, CA
Data from Optimer Pharmaceuticals Prulifloxacin Phase 3 Trial in Travelers Diarrhea and Strain Typing Data from OPT-80 Study to be Presented at ICAAC/IDSA Annual Meeting

(9.10.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at Two Upcoming Investor Conferences

(9.2.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Completes Enrollment in Second Prulifloxacin Phase 3 Clinical Trial

(8.28.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at BioCentury NewsMakers Conference

(8.6.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Reports Second Quarter 2008 Financial Results

(7.30.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at August 2008 Investor Conferences

(7.28.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Completes $14.8 Million Registered Direct Offering

(7.23.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Completes Enrollment in OPT-80 Phase 3 Clinical Trial in Patients with Clostridium difficile Infection

(7.21.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Raise $12.2 Million in Registered Direct Offering

(7.17.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Announces Change to Board of Directors

(7.16.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Announces Positive Results in Prulifloxacin Phase 3 Study

(6.26.2008) SAN DIEGO, CA
Optimer Reports Additional Data on Investigational Compound OPT-80 at Anaerobe 2008 Congress

(6.17.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at Two Upcoming Investor Conferences

(6.11.2008) SAN DIEGO, CA
Optimer to Present Additional Data from OPT-80 Phase 2A Study for Clostridium difficile Infection at Anaerobe 2008 Congress

(6.3.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at Needham Biotechnology & Medical Technology Conference

(5.27.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Receives Polymorph Patent for Lead Product Candidate OPT-80

(5.7.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Reports First Quarter 2008 Financial Results

(5.6.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Present at Upcoming Investor Conferences

(4.21.2008) BARCELONA, SPAIN
Clostridium difficile Infection 'Epidemic' Leads to Calls for Emerging Next-Generation Therapies

(4.15.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Sponsors ECCMID Symposium on Clostridium difficile-Associated Disease: Current Treatment and Challenges

(4.8.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Receives Notice of Allowance for OPT-80 Patent Application

(4.2.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Announces Peer-Reviewed Publication of OPT-80 Phase 1 Clinical Results for the Treatment of Clostridium Difficile Infection

(3.26.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Financial Results

(3.19.2008) SAN DIEGO, CA
Optimer Pharmaceuticals to Host Conference Call and Webcast to Discuss Fourth Quarter and Full Year 2007 Financial Results

(3.11.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Completes Enrollment in Phase 3 Clinical Trial of Prulifloxacin in Patients with Travelers’ Diarrhea

(1.7.2008) SAN DIEGO, CA
Optimer Pharmaceuticals Awarded Grant from the National Institutes of Health for Development of OPT-80 to Treat Deadly Hospital Associated Infection

(9.2.2008) SAN DIEGO, CA

Optimer Pharmaceuticals Completes Enrollment in Second Prulifloxacin Phase 3 Clinical Trial



SAN DIEGO, CA – September 2, 2008

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the company has completed enrollment in the second of two planned phase 3 clinical trials evaluating the safety and efficacy of Prulifloxacin for the treatment of infectious diarrhea in travelers. The Company previously reported positive top-line data from the first Phase 3 trial which showed that Prulifloxacin met the primary endpoint of Time to Last Unformed Stool (TLUS), a measure of the time to resolution of diarrhea, compared to placebo with a p-value of <0.0001.  If the results of this second study are also positive, the Company expects to use these studies as a basis for a New Drug Application filing in 2009.

 

Travelers’ diarrhea is infectious diarrhea caused by bacteria, viruses or parasites and is contracted by the ingestion of contaminated food or water.  This infection is characterized by diarrhea along with other related symptoms including nausea, vomiting, abdominal pain or cramping, and fecal urgency.

 “We are very excited to have completed enrollment in the second trial,” said Michael N. Chang, Ph.D., CEO and President of Optimer. “We look forward to completing the analysis of the data from this trial and we expect top-line results in the fourth quarter.”  

This multi-center, double-blind, randomized and placebo-controlled clinical trial compares the safety and efficacy of Prulifloxacin versus placebo in adult travelers suffering from acute bacterial gastroenteritis. Clinical trial sites included locations in India, Guatemala, and Mexico. The primary endpoint is TLUS and secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates.

 

About Optimer Pharmaceuticals

 

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates.  OPT‑80 is being developed for the treatment of Clostridium difficile infection, the most common hospital-acquired diarrhea.  Prulifloxacin is an antibiotic being developed for the treatment of travelers’ diarrhea, a form of infectious diarrhea.  Additional information can be found at http://www.optimerpharma.com.

 

 

Forward-looking Statements

 

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to Prulifloxacin and the timing of clinical trials and regulatory filings and anticipated results thereof.  Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.

 

Contacts

Optimer Pharmaceuticals, Inc.

Christina Donaghy, Corporate Communications Manager

John D. Prunty, Chief Financial Officer & VP Finance

858-909-0736

 

Porter Novelli Life Sciences

Jason I. Spark, Vice President

619-849-6005