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Optimer Pharmaceuticals Reports Second Quarter 2009 Financial Results
Date:8/5/2009

SAN DIEGO, Aug. 5 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today reported financial results for the second quarter ended June 30, 2009. Optimer reported a net loss for the second quarter of 2009 of $12.4 million, or $0.37 per share, which was in line with the Company's expectations. This compares to a net loss for the second quarter of 2008 of $8.1 million, or $0.29 per share. The increase in net loss was primarily due to higher research and development expenses. Research and development expenses in the second quarter of 2009 were $10.5 million, compared to $6.2 million in the second quarter of 2008. The increase was primarily due to manufacturing scale-up expenses and expenses to prepare regulatory filings related to the Company's fidaxomicin and prulifloxacin programs.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090413/LA97352LOGO)

As of June 30, 2009, Optimer held cash, cash equivalents and short-term investments of $51.2 million.

"During the second quarter, we had the first oral presentations of our North American Phase 3 fidaxomicin data at major scientific conferences showing that fidaxomicin is more effective than oral vancomycin when it comes to reducing recurrence of CDI, even in high risk patient populations," said Michael N. Chang, Ph.D., Optimer's President and Chief Executive Officer. "As we head into the second half of this year, we look forward to presenting additional data from this study at ICAAC and IDSA and we are focused on completing our second fidaxomicin Phase 3 trial and preparing regulatory filings for fidaxomicin and prulifloxacin."

Recent Corporate Highlights

  • Clinical investigator, Thomas J. Louie, M.D., presented top-line data from Optimer's fidaxomicin North American Phase 3 clinical study for patients with Clostridium difficile infection at the European Congress of Clinical Microbiology and Infectious Diseases meeting, which showed the trial met its primary endpoint of achieving clinical cure compared to Vancocin(R). In addition, the top-line data showed that patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to Vancocin (p=0.006).
  • Clinical investigator, Mark A. Miller, M.D., presented additional data from Optimer's fidaxomicin North American Phase 3 clinical study at the Digestive Disease Week 2009 Conference focusing on patient risk factors believed to be predictive of CDI recurrence following treatment. These risk factors include albumin levels, white blood cell (WBC) count and temperature and strain types of CDI. The data showed that fidaxomicin overall demonstrated a lower recurrence rate compared to Vancocin (p=0.004) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains.
  • The United States Patent and Trademark Office issued Optimer a production patent covering steps used in the manufacture of fidaxomicin.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials 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 the development of fidaxomicin and prulifloxacin, the timing of clinical trials and anticipated results, and plans related to regulatory filings and presentations of clinical trial results. 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, uncertainty regarding regulatory requirements for approval, the timing of regulatory submissions and the uncertainty regarding whether such submissions will be accepted or approved, and other risks detailed in Optimer's filings with the Securities and Exchange Commission.

    Contacts

    Optimer Pharmaceuticals, Inc.
    John Prunty, CFO & VP, Finance
    Christina Donaghy, Corporate Communications Manager
    858-909-0736

    Porter Novelli Life Sciences
    Jason I. Spark, Vice President
    619-849-6005



                              Optimer Pharmaceuticals, Inc.
                          Consolidated Statements of Operations
                                       (unaudited)

                             Three Months  Ended        Six Months Ended
                                   June 30,                 June 30,
                              -----------------         -----------------
                              2009         2008         2009         2008
                              ----         ----         ----         ----
    Revenues:
      Research grants      $324,778     $118,797      $407,790      $605,463
      Collaborative
       research
       agreements           100,000       50,000       100,000        50,000
                            -------       ------       -------        ------
        Total revenues      424,778      168,797       507,790       655,463
    Operating expenses:
      Research and
       development       10,528,482    6,220,482    19,327,064    13,125,858
      Marketing             475,062      913,916       785,348     1,279,484
      General and
       administrative     1,871,309    1,521,446     3,919,809     3,258,497
                          ---------    ---------     ---------     ---------
        Total operating
         expenses        12,874,853    8,655,844    24,032,221    17,663,839
                         ----------    ---------    ----------    ----------
    Loss from
     operations         (12,450,075)  (8,487,047)  (23,524,431)  (17,008,376)
    Interest income
     and other, net          88,070      433,750       275,038     1,015,034
                             ------      -------       -------     ---------
    Net loss           $(12,362,005) $(8,053,297) $(23,249,393) $(15,993,342)
                       ============  ===========  ============  ============

    Basic and
     diluted net
     loss per share          $(0.37)      $(0.29)       $(0.73)       $(0.57)
                             ======       ======        ======        ======

    Shares used
     to compute
     basic and
     diluted net
     loss per share      33,083,447   27,891,870    31,816,553    27,880,772
                         ==========   ==========    ==========    ==========





                           Optimer Pharmaceuticals, Inc.
                     Condensed Consolidated Balance Sheets

                                                      June 30,   December 31,
                                                        2009         2008
                                                        ----         ----
                                                    (unaudited)
           ASSETS
    Current assets:
      Cash and cash equivalents                     $26,217,128  $16,778,880
      Short-term investments                         24,935,778   22,547,515
      Prepaid expenses and other current assets         810,556      744,670
                                                        -------      -------
    Total current assets                             51,963,462   40,071,065
    Property and equipment, net                         623,892      694,183
    Long-term investments                               882,000    1,032,000
    Other assets                                        498,171      498,250
                                                        -------      -------
    Total assets                                    $53,967,525  $42,295,498
                                                    ===========  ===========

        LIABILITIES  AND STOCKHOLDERS' EQUITY
    Current liabilities:
      Accounts payable                               $4,091,178   $3,767,831
      Accrued expenses                                4,099,069    4,045,660
                                                      ---------    ---------
    Total current liabilities                         8,190,247    7,813,491
    Deferred rent                                       284,828      251,504
    Commitments and contingencies                             -            -
    Stockholders' equity                             45,492,450   34,230,503
                                                     ----------   ----------
    Total liabilities and stockholders' equity      $53,967,525  $42,295,498
                                                    ===========  ===========



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SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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