0001104659-11-018791.txt : 20110406 0001104659-11-018791.hdr.sgml : 20110406 20110406060217 ACCESSION NUMBER: 0001104659-11-018791 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20110405 ITEM INFORMATION: Other Events FILED AS OF DATE: 20110406 DATE AS OF CHANGE: 20110406 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OPTIMER PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001142576 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330830300 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33291 FILM NUMBER: 11741924 BUSINESS ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8589090736 MAIL ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a11-9719_18k.htm 8-K

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  April 5, 2011

 

 

OPTIMER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction of
incorporation)

 

001-33291
(Commission File Number)

 

33-0830300
(I.R.S. Employer
Identification No.)

 

10110 Sorrento Valley Road, Suite C

San Diego, California
(Address of principal executive offices)

 

92121
(Zip Code)

 

Registrant’s telephone number, including area code: (858) 909-0736

 

Not Applicable.

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 8.01               Other Events.

 

On April 5, 2011, the Company announced that the U.S. Food and Drug Administration’s (the “FDA”) Anti-Infective Drugs Advisory Committee (the “AIDAC”) voted unanimously (13 to 0) that the Company adequately demonstrated the safety and effectiveness of DIFICID™ (fidaxomicin) for the treatment of Clostridium difficile infection (CDI).

 

Although the AIDAC provides recommendations to the FDA, the FDA makes the final decision with respect to approval of a drug. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) action date of May 30, 2011 for its review of Optimer’s New Drug Application (NDA) for DIFICID.

 

The AIDAC was also asked whether the finding of lower recurrence of CDI after 30 days in patients treated with DIFICID compared to those treated with vancomycin in the Company’s Phase 3 trials was clinically significant.  The AIDAC vote was split 6 to 6 with 1 abstention on the question, although the committee members favored including in the product label a description of DIFICID’s superiority over vancomycin in providing sustained resolution of disease 30 days after treatment.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

OPTIMER PHARMACEUTICALS, INC.

 

 

 Dated: April 6, 2011

By:

/s/ John D. Prunty

 

 

John D. Prunty

 

 

Chief Financial Officer (Duly Authorized Officer and Principal Financial and Accounting Officer)

 

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