SAN DIEGO, Nov. 14 Cadence Pharmaceuticals, Inc.(Nasdaq: CADX), a biopharmaceutical company focused on in-licensing,developing and commercializing proprietary product candidates principally foruse in the hospital setting, today reported unaudited financial results forthe third quarter and nine months ended September 30, 2007, as well as anupdate on the company's clinical development program for intravenousacetaminophen.
"During the quarter, we continued to make progress in advancing our PhaseIII clinical development programs for our two drug candidates, intravenousacetaminophen, which we have recently branded Acetavance(TM), for thetreatment of pain and fever, and Omigard(TM), a topical gel for the preventionof catheter-related infections," stated Ted Schroeder, President and ChiefExecutive Officer of Cadence. "We remain on track to meet our clinical andpre-commercialization milestones for the rest of this year, to announce topline results from our first three pivotal efficacy trials of Acetavance inearly 2008, to complete patient enrollment in our Phase III clinical trial ofOmigard in the second quarter of 2008 and to submit a New Drug Application, orNDA, for Acetavance to the U.S. Food and Drug Administration in the secondhalf of 2008."
"In October 2007, we completed patient enrollment in our two pivotal PhaseIII clinical trials of Acetavance for the treatment of fever in adults," addedJim Breitmeyer, Executive Vice President, Development and Chief MedicalOfficer of Cadence. "Before year end, we also plan to begin enrollment in ourtwo planned safety studies of this product candidate. We will also initiatean additional pivotal, Phase III clinical trial of Acetavance for thetreatment of acute pain in adults following abdominal laparoscopic surgery.This study is not expected to delay our NDA submission timeline."
"The additional study is a nice complement to the rest of the Acetavanceprogram, because it will provide data in laparoscopic surgery, an increasinglycommon alternative to more extensive procedures," said Eugene R. Viscusi,M.D., Director, Acute Pain Management Service, Thomas Jefferson University,Jefferson Medical College, a member of Cadence's advisory board forAcetavance. "If the studies are successful and Acetavance is approved, Ibelieve that physicians will also appreciate the flexibility of two differentdoses and dosing intervals, and having prescribing information in patientswith mild to moderate pain, which will supplement findings from the moresevere pain models studied in the other Acetavance clinical trials."
Cadence reported a net loss for the third quarter of 2007 of $13.0million, or $0.45 per share, compared to a net loss of $7.8 million, or $6.01per share, in the third quarter of 2006. For the nine months ended September30, 2007, the company reported a net loss of $37.5 million, or $1.31 pershare, compared to a net loss of $43.2 million, or $34.27 per share for thenine months ended September 30, 2006.
As of September 30, 2007, Cadence held cash and cash equivalents of $54.5million.
Total operating expenses for the third quarter of 2007 were $13.6 million,compared to $8.0 million for the third quarter of 2006. The increase inoperating expenses was primarily due to a $4.0 million increase in researchand development expenses related to the company's ongoing Phase III clinicaltrials of Omigard and Acetavance. In addition, the increased operatingexpenses were due to pre-commercialization manufacturing developmentactivities for Acetavance, increased personnel-related costs due to theplanned hiring of staff to support the company's clinical and regulatoryactivities, and a $1.2 million increase in general and administrative expensesdue to increases in salaries and related personnel costs, includingstock-based compensation charges and costs related to operating as a publicc