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Pain Therapeutics Reviews Mid-Year Progress, Reports Second Quarter 2009 Financial Results
Tuesday, August 04, 2009 9:57 AM


(Source: PrimeNewswire)tracking
       -  Hemophilia and Melanoma Data Expected by Year End -    -  Net Loss for the Quarter Ended June 30, 2009 was $34,000 -    - $182.2 Million of Cash, or $4.33 Cash per Share, No Debt as                            of June 30, 2009 - 

SAN MATEO, Calif., Aug. 4, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reviewed mid-year progress with its drug candidates and reported financial results for the quarter ended June 30, 2009.

"2009 is shaping up to be a year of significant progress across our entire business," said Remi Barbier, President and Chief Executive Officer of Pain Therapeutics. "By year end 2009, we expect to announce top-line results from on-going studies with our drug candidates in two important disease areas - hemophilia and melanoma. Financially, we remain committed to a strong balance sheet and a modest cash burn rate, while we wait for King Pharmaceuticals, Inc., our commercial partner on abuse-resistant pain medications, to re-submit the NDA for Remoxy(r) in 2010."

Net loss for the quarter ended June 30, 2009 was $34,000, or $0.00 per share, compared to net loss of $1.0 million, or $0.02 per share, for the second quarter of 2008. Net loss for the six months ended June 30, 2009 was $1.9 million, or $0.04 per share, compared to net income of $1.5 million, or $0.04 per share, for the six months ended June 30, 2008.

Pain Therapeutics had cash, cash equivalents and marketable securities of $182.2 million, or about $4.33 cash per share, and no debt as of June 30, 2009.

Remoxy Remains Top Priority

Pain Therapeutics remains committed to the regulatory success of Remoxy, our lead drug candidate. Remoxy is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. We are developing Remoxy, and other abuse-resistant painkillers, with King Pharmaceuticals, Inc. We believe Remoxy represents the rare combination of a well-partnered, late-stage drug asset with a unique profile, and whose clinical efficacy has been substantially de-risked.

     *  Pursuant to the terms of a strategic alliance, King funds      all development expenses incurred by us for Remoxy and three      other abuse-resistant pain medications.    *  From 2005 to 2008, we and King jointly managed a Phase III      clinical program and a New Drug Application (NDA) for Remoxy.      In mid-2008, the U.S. Food and Drug Administration (FDA)      accepted the Remoxy NDA with Priority Review.    *  In December 2008, we received from the FDA a Complete      Response Letter which indicated additional non-clinical data      is required to support the approval of Remoxy.  The FDA has      not requested or recommended additional clinical efficacy      studies prior to approval.    *  In March 2009, King assumed sole responsibility for the      regulatory approval of Remoxy.  This shift of responsibility      does not change the economic terms of our strategic alliance      with King.    *  In July 2009, King met with the FDA to discuss Remoxy.  As      a result of this meeting, King anticipates a resubmission      of the Remoxy NDA in 2010.    *  Upon FDA approval of Remoxy, we will receive from King a      $15.0 million cash milestone payment and a running royalty      equal to 20% of net sales of drugs developed under this      strategic alliance, except as to the first $1.0 billion in      cumulative net sales, which royalty is set at 15%. 

Broad Commitment to Biotechnology

Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. We are making disciplined investments focused on advancing novel drugs in two important disease areas - hemophilia and melanoma. We own all commercial rights to our novel drug candidates. We expect to announce new data in both disease areas by year end 2009.

     *  A radio-labeled monoclonal antibody program, developed at      Albert Einstein College of Medicine, is aimed at treating      patients with late-stage (metastatic) melanoma.  This drug      is called PTI-188.    *  In 2008, we completed a first-in-man clinical study with      PTI-188.  In this study, researchers in Israel administered      PTI-188 to 12 patients diagnosed with metastatic melanoma.      Encouraging data were observed, and later published at the      2008 Meeting of the Society for Nuclear Medicine.    *  In May 2009, we announced the initiation of a new Phase I      study in metastatic melanoma in Israel using PTI-188. This      study is on-going.  Thus far, researchers have treated two      cohorts of patients. We expect to enroll a third cohort of      patients in this study by year end 2009.    *  We have a gene transfer program, developed at Stanford      University, aimed at correcting an underlying genetic defect      in patients with hemophilia.  Importantly, no viral vector      is utilized.


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