Navigation Links
Trading Halted Today in Optimer Pharmaceuticals Stock
Date:4/5/2011

SAN DIEGO, April 5, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced today that NASDAQ has halted trading of the Company's common stock this morning.  The Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and Drug Administration (FDA) is scheduled to meet today to review and discuss Optimer's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection.

(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)

Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). In two Phase 3 trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI.  Importantly, fidaxomicin reduced the risk of recurrence by 47% compared to vancomycin. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," which appeared in the February 3, 2011 issue.  Optimer filed a marketing application in the EU for fidaxomicin for the treatment of CDI and reducing risk of recurrence when used for treatment of initial CDI.  

About Clostridium difficile Infection (CDI)

Clostridium difficile infection (CDI), commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S.  It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.

Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The rise in incidence of CDI, along with high rates of both treatment failures and recurrences with current therapies has resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.

About Optimer

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.

Contacts

Optimer Pharmaceuticals, Inc.
Christina Donaghy, Corporate Communications Manager
John D. Prunty, Chief Financial Officer & VP Finance
858-909-0736

Canale Communications, Inc.
Jason I. Spark, Senior Vice President
619-849-6005


'/>"/>
SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Milestone Scientific Inc. Commences Trading on the OTC Pink
2. ERT to Change Trading Symbol to "ERT" Effective March 7, 2011 to Properly Align Business Brand
3. SCOLR Pharma, Inc. Common Stock to Begin Trading on OTC Bulletin Board and OTCQB Stock Market on January 13, 2011
4. BioDrain Medical, Inc. Is Eligible for Trading on the OTCBB, Notice of Allowance on Canadian Patent Application
5. China PharmaHub Corp. Begins Trading Under Stock Symbol CPHB Instead of WRLC
6. AcuNetx Announces Change in Trading Status
7. Interleukin Genetics Moves Trading of Stock to OTCQB Marketplace
8. Renhuang Begins Trading on NYSE Amex
9. AutoImmune Inc. Files Certificate of Dissolution and Completes Sale of Colloral® Business; Trading of Common Stock to Cease After June 30, 2010
10. Trading Halted Today in Questcor Pharmaceuticals Common Stock
11. MyPunchbowl Inks Deal with Oriental Trading Company
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... 2016  Palatin Technologies, Inc. ("Palatin") (NYSE MKT: ... previously disclosed underwritten public offering of units with ... sole book-running manager, Roth Capital Partners acted as ... co-manager for the offering. "This financing ... proceeds, allowing us to continue advancing bremelanotide for ...
(Date:12/7/2016)... Md. , Dec. 7, 2016  Northwest ... or the "Company"), a biotechnology company developing DCVax® ... announced that the Nasdaq Staff has not accepted ... of Listing Rules previously reported, and the Company ... withdraw the Company,s common stock from listing on ...
(Date:12/7/2016)... , December 7, 2016 ... Trial Management System (CTMS) Market, by Components (Software, ... Site), End-users (Pharmaceutical and Biotechnology Companies, Clinical Research ... Share, Size and Forecast to 2022", published by ... system (CTMS) market is expected to grow at ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... , ... AlignLife clinics nationwide are giving back to their communities by collecting ... bountiful gifts wrapped tightly under a Christmas Tree. AlignLife hopes to spread the ... , In exchange for generous donations, customers will receive a gift in return. ...
(Date:12/7/2016)... ... 2016 (PRWEB) (PRWEB) December 07, 2016 , ... Man’s best ... Dermatitis Associated with Borrelia Infection” reveals that a condition similar to ... prestigious Journal of Veterinary Science & Medical Diagnosis. , Morgellons disease is an ...
(Date:12/7/2016)... ... December 07, 2016 , ... The Honolulu cosmetic ... redesigned website, which launched October 17, 2016, features comprehensive information regarding a wide ... layout. Visitors and patients can discover the latest clinical dermatology treatments for medical ...
(Date:12/7/2016)... ... December 07, 2016 , ... Delete® - Tattoo Removal and Laser ... Holiday Party Season. Save Up To 33% Off Botox® and Juvederm® Products Now Through ... Phoenix Valley with Delightful Deals on Botox® and Juvederm® just in time ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... Campaign Winner in the Folio: Marketing Awards competition. Live From won in the ... in pioneering, inventive, and ultimately successful projects undertaken by the media industry’s most ...
Breaking Medicine News(10 mins):