Phase III Clinical Trial of Acetavance(TM) for the Treatment of Fever
Achieves Primary Endpoint
Phase III Clinical Trial of Omigard(TM) Completes Patient Enrollment
SAN DIEGO, May 6 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the quarter ended March 31, 2008 and provided an update on the clinical development programs for its product candidates Acetavance(TM), an intravenous formulation of acetaminophen, and Omigard(TM), a topical antimicrobial gel.
The company announced that a Phase III clinical trial of Acetavance successfully met its primary endpoint of achieving a more rapid onset of action in the treatment of fever compared to oral acetaminophen. In addition, Cadence announced that it completed its goal of enrolling 1,850 patients in its Phase III clinical trial of Omigard for the prevention of catheter-related infections.
"We are very pleased with the outcome of our second Phase III clinical trial for the treatment of fever in adults. In addition to the positive data from our first Phase III clinical trial of Acetavance in fever announced earlier this year, we believe that the results of this study further strengthen the value proposition for Acetavance," said Ted Schroeder, President and Chief Executive Officer of Cadence. "We believe that there is a significant unmet need among patients and physicians in the hospital setting for a safe and effective treatment for pain and fever, particularly in cases where patients cannot take oral medication or require a more rapid onset of action."
"Reaching the patient enrollment target in our Phase III clinical trial of Omigard for the prevention of catheter-related infections is a major milestone in our clinical development program for this product candidate," stated James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "If approved, we believe that Omigard will address a rapidly growing need for more effective ways to lower hospital acquired infection rates, including the dangerous and costly complications from infections related to intravascular catheters."
Cadence's second clinical trial of Acetavance for the treatment of fever in adults, designated Study 303, was a Phase III, randomized, double-blind, double-dummy, single-dose study of intravenous acetaminophen (1 gram) compared to oral acetaminophen (1 gram) for the treatment of fever in 81 adult volunteers with experimentally-induced fever. In this study, a statistically significant difference in favor of Acetavance was observed compared to oral acetaminophen for the primary efficacy endpoint of WSTD2 (the weighted sum of temperature differences over two hours) (p< 0.01). The mean temperature scores for patients in the Acetavance-treated group were significantly lower as early as 15 minutes after the study drug was administered. The peak temperature observed in the Acetavance group of patients was also significantly lower. Acetavance was very well tolerated, including no treatment-emergent serious adverse events or treatment-emergent hepatic adverse events.
Cadence's confirmatory Phase III clinical trial of Omigard (omiganan pentahydrochloride 1% gel), known as the Central Line Infection Reduction Study, or CLIRS, is a randomized, evaluator-blinded study in hospitalized patients whose medical condition requires a short-term central venous catheter. The primary objective of CLIRS is to evaluate the efficacy and safety of Omigard compared to 10% povidone-iodine in reducing local catheter site infections. The company achieved its goal of enrolling 1,850 patients at 58 clinical trial sites in the United States and Europe. CLIRS is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA).
First Quarter 2008 Financial Results
For the first quarter ended March 31, 2008, Cadence reported a net loss of $13.7 million, or $0.42 per share, compared to a net loss of $9.6 million, or $0.34 per share, for the same period in 2007.
As of March 31, 2008, Cadence held cash and cash equivalents of $91.4 million, which included proceeds from the registered direct offering completed in February 2008, pursuant to which Cadence issued and sold approximately 9.2 million shares of common stock at a price of $5.34 per share, and received net proceeds of approximately $49.1 million.
Operating expenses for the first quarter ended March 31, 2008, were $13.8 million, an increase of $3.4 million from the $10.4 million reported for the same period in 2007. This increase was primarily a result of $1.7 million of additional research and development costs related to ongoing Phase III clinical trials and pre-commercialization manufacturing development activities for Acetavance and Omigard. Other supporting costs for research and development activities increased $0.5 million, which included a $0.2 million increase in stock-based compensation.
In addition, the increased operating expenses were due to a $0.3
million increase in market research and personnel-related activities for
Omigard, and an increase of $0.8 million in general and administrative
expenses, including a $0.4 million increase in stock-based compensation
Acetavance(TM) Clinical Program Update
o Following the announcement of results for Acetavance Studies 301 and
302 in January 2008, Cadence initiated discussions with the FDA to
determine if the company may need to conduct additional trials or modify
its ongoing trials of this product candidate. Cadence currently expects
to receive guidance from the FDA in the second quarter of 2008.
o During the first quarter of 2008, Cadence also implemented several
design enhancements to Study 304, a Phase III clinical trial of
Acetavance for the treatment of acute pain in adults following abdominal
laparoscopic surgery. The trial design modifications included tightening
patient eligibility criteria, performing more frequent pain assessments
and increasing control of opioid medications. Cadence currently expects
to complete enrollment of this clinical trial in the third quarter of
2008 and announce top-line data in the second half of 2008.
o Also during the first quarter of 2008, Cadence initiated a multi-day
safety study of Acetavance in adult patients and a multi-day safety
study of Acetavance in pediatric patients.
o Assuming the successful outcome of Cadence's planned clinical trials for
Acetavance, and FDA concurrence with its proposed clinical development
plan, the company currently expects to submit a 505(b)(2) New Drug
Application (NDA) for this product candidate to the FDA in the first
half of 2009.
Acetavance Clinical Trials Study Phase Status
Treatment of pain following total
knee & hip replacement Sinatra(1) III Completed
Treatment of pain following abdominal
gynecologic surgery 301 III Completed
Treatment of fever in adults (vs. placebo) 302 III Completed
Treatment of fever in adults (onset
of action) 303 III Completed
Adult pharmacokinetics 101 I Completed
Treatment of pain following abdominal
laparoscopic surgery 304 III Enrolling
Adult safety 351 III Enrolling
Pediatric safety 352 III Enrolling
Pediatric pharmacokinetics 102 I Enrolling
(1) Conducted by Bristol-Myers Squibb Company
Omigard(TM) Clinical Program Update
o Cadence currently expects to announce top-line data from CLIRS in the
second half of 2008 and, if the results are positive, submit an NDA for
Omigard to the FDA in the first half of 2009.
Conference Call and Webcast on May 6, 2008 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time)
Cadence management will host a conference call on May 6, 2008 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time) and interested investors may participate in the conference call by dialing 877-675-4750 (domestic) or 719-325-4865 (international). To access the webcast, please visit the company's website at http://www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call and remain available on the company's website until the next quarterly financial results call.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company currently has two Phase III product candidates in development, Acetavance(TM) (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements. Forward-looking statements include statements regarding: the timeframes in which Cadence expects to complete enrollment in, and announce the results of, clinical trials of its product candidates; the timeframes in which Cadence anticipates filing submissions with regulatory authorities seeking marketing authorizations for its product candidates; the expected impact of clinical trial results on the market and clinical value of Cadence's product candidates; and the potential for Cadence's product candidates to address unmet medical needs. The inclusion of forward-looking statements should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Cadence's business, including, without limitation: the outcomes of final analyses of data from Cadence's clinical trials of its product candidates may vary from the company's initial analyses, and the FDA may not agree with Cadence's interpretation of such results; the company's clinical trials may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials; Cadence may experience delays in completing its clinical trials or achieving its product development goals, or experience problems with the designs or execution of its clinical trials; the company may decide, or be required by FDA, to expand or modify its ongoing clinical trials or conduct additional clinical trials in order to support applications for market approval of its product candidates; the market demand for Cadence's product candidates, and their ability to compete with new or existing products, may be less than anticipated; the company's product candidates may have unanticipated adverse side effects or inadequate therapeutic efficacy; Cadence may experience delays and increased costs with respect to completion of pre-commercialization manufacturing development activities, and may be required to perform additional pre-clinical or clinical testing as a result of changes to manufacturing processes for its product candidates; the company may require substantial additional funding to complete its clinical development programs and successfully launch its products, and it may not be able to raise sufficient capital when needed, or at all; and other risks detailed in Cadence's prior press releases as well as in Cadence's periodic public filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Cadence(TM), Acetavance(TM) and Omigard(TM) are trademarks of Cadence
Contacts: William R. LaRue
SVP & Chief Financial Officer
Cadence Pharmaceuticals, Inc.
Director, Investor Relations
Cadence Pharmaceuticals, Inc.
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
Research and development $10,478,047 $8,241,804
Marketing 583,702 302,183
General and administrative 2,667,038 1,827,592
Other 28,257 -
Total operating expenses 13,757,044 10,371,579
Loss from operations (13,757,044) (10,371,579)
Other income (expense):
Interest income 550,380 1,031,890
Interest expense (506,856) (220,009)
Other expense (3,395) -
Total other income, net 40,129 811,881
Net loss $(13,716,915) $(9,559,698)
Basic and diluted net loss
per share(1) $(0.42) $(0.34)
Shares used to compute basic
and diluted net loss per
share(1) 32,921,093 28,402,352
(1) As a result of the issuance of 9,240,307 shares of common stock
pursuant to an effective shelf registration in the first quarter of
2008, there is a lack of comparability in the per share amounts
between the 2008 and 2007 periods presented.
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
March 31, December 31,
Cash and cash equivalents $91,443,447 $55,392,921
Restricted cash 1,981,848 1,981,848
Prepaid expenses and other
current assets 1,211,887 959,321
Total current assets 94,637,182 58,334,090
Property and equipment, net 5,280,094 5,139,538
Restricted cash 885,434 885,434
Other assets 242,743 252,963
Total assets $101,045,453 $64,612,025
Liabilities and Stockholders' Equity
Accounts payable $2,943,002 $1,974,991
Accrued liabilities 13,306,016 13,901,770
Current portion of long-term debt 7,127,222 5,617,928
Total current liabilities 23,376,240 21,494,689
Deferred rent 1,159,187 1,224,869
Long-term debt, less current portion
and discount 11,308,814 13,412,349
Other long-term liabilities 22,048 22,048
Total stockholders' equity 65,179,164 28,458,070
Total liabilities and
stockholders' equity $101,045,453 $64,612,025
|SOURCE Cadence Pharmaceuticals, Inc.|
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