Navigation Links
Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID™
Date:9/23/2011

SAN DIEGO, Sept. 23, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD).

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

DIFICLIR, which is known as DIFICID™ in the United States (US), was approved by the US FDA in May 2011 for the treatment of CDAD in adults 18 years of age and older. Astellas is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States.

The CHMP positive opinion is based on Phase 3 clinical studies that were conducted to compare the safety and efficacy of 400mg/day fidaxomicin with 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in North America (US and Canada). The second Phase 3 study was carried out in 535 subjects in North America and Europe. The results of the studies showed that the proportion of subjects in which clinical cure was achieved at the end of 10 days of treatment were similar for both treatments; thus fidaxomicin met its primary endpoint of non-inferiority to vancomycin. Furthermore in both trials, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin at 30 days after completion of treatment.

"A positive CHMP opinion is an important milestone for Optimer and is a key step to making fidaxomicin more widely available to patients around the globe for this serious disease," said Pedro Lichtinger, President and CEO of Optimer.

The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP opinion.

Important Safety Information for DIFICID

  • DIFICID should not be used for systemic infections
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria
  • The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)

About CDAD

Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD 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 CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older.

About Optimer Pharmaceuticals

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 developed and is commercializing DIFICID™ (fidaxomicin) tablets, an FDA-approved antibacterial drug for the treatment of adult patients 18 years of age and older with Clostridium difficile-associated diarrhea (CDAD). Optimer's clinical pipeline includes Pruvel™, a product in the fluoroquinolone class of antibiotics that has completed Phase 3 trials as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.

Forward-Looking Statements

Statements included in this release that are not a description of historical facts are forward-looking statements, including without limitation statements related to the potential regulatory approval of DIFICLIR in the EU, whether the EMA and other regulatory authorities will follow the opinion of the CHMP, the expected timing of a decision on the DIFICLIR MAA filing and the potential availability of DIFICLIR to European CDI patients.  Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Astellas or Optimer that any of their plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Astellas' and Optimer's businesses including, without limitation, risks relating to: whether regulatory authorities will review or approve  applications for marketing approval within anticipated timelines or at all, Astellas' ability to successfully commercialize DIFICLIR, if approved, whether DIFICLIR will receive reimbursement from government authorities and other healthcare payors, and other risks detailed in Optimer's filings with the U.S. Securities and Exchange Commission.

Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
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. Optimer to Provide DIFICID™ Launch Update at Morgan Stanley Global Healthcare Conference
2. Optimer Pharmaceuticals DIFICID Featured in 11 Presentations at 51st ICAAC
3. Optimer Pharmaceuticals to Present at September 2011 Investor Conferences
4. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimers DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receivin
6. Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results
7. Optimer Launches DIFICID™ (fidaxomicin) Tablets for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) in Patients 18 Years of Age and Older
8. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
9. Optimer Pharmaceuticals to Present at the Jefferies 2011 Global Healthcare Conference
10. Optimer Pharmaceuticals Reports First Quarter 2011 Financial Results
11. Optimer Pharmaceuticals Expands Senior Management Team
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SOUTH SAN FRANCISCO, Calif. , June 24, ... GBT ), a biopharmaceutical company developing novel ... with significant unmet needs, today announced the closing ... 6,400,000 shares of common stock, at the public ... the shares in the offering were offered by ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
Breaking Medicine News(10 mins):