Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update.Phase III Clinical Trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of Acetavance(TM) for the Treatment of Fever Achieves Primary Endpoint
Phase III Clinical Trial of Omigard(TM) Completes Patient Enrollment
SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. , May 6 /PRNewswire-FirstCall/ -- Cadence cadence, in music, the ending of a phrase or composition. In singing the voice may be raised or lowered, or the singer may execute elaborate variations within the key. Pharmaceuticals, Inc. , 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 intravenous /in·tra·ve·nous/ (-ve´nus) within a vein or veins.intrave´nously
adj. Abbr. IV
Within or administered into a vein. formulation of acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. , and Omigard(TM), a topical antimicrobial antimicrobial /an·ti·mi·cro·bi·al/ (-mi-kro´be-al)
1. killing microorganisms or suppressing their multiplication or growth.
2. an agent with such effects. 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 onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. 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 Frederick ("Ted") Rudolph Schroeder (July 20, 1921 – May 26, 2006) was an American tennis player who won the two most prestigious amateur tennis titles, Wimbledon and the United States Open. , President and Chief Executive Officer of Cadence. "We believe that there is a significant unmet un·met
Not satisfied or fulfilled: unmet demands. 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 intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel.
Within one or more blood vessels. catheters."
Cadence's second clinical trial of Acetavance for the treatment of fever in adults, designated Study 303, was a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA , randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , 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 hepatic /he·pat·ic/ (he-pat´ik) pertaining to the liver.
1. Of, relating to, or resembling the liver.
2. Acting on or occurring in the liver.
n. 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 central venous catheter
A catheter passed through a peripheral vein and ending in the thoracic vena cava; it is used to measure venous pressure or to infuse concentrated solutions. . The primary objective of CLIRS is to evaluate the efficacy and safety of Omigard compared to 10% povidone-iodine in reducing local catheter catheter /cath·e·ter/ (kath´e-ter)
1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid.
2. urethral c. site infections. The company achieved its goal of enrolling 1,850 patients at 58 clinical trial sites in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 Net Proceeds
The amount received after all costs are deducted from the sale of a piece of property or security.
In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $49.1 million.
Operating expenses Operating expenses
The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. 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 charges.
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. Enrollment 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 Investor relations
The process by which the corporation communicates with its investors. 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 INCONCLUSIVE. What does not put an end to a thing. Inconclusive presumptions are those which may be overcome by opposing proof; for example, the law presumes that he who possesses personal property is the owner of it, but evidence is allowed to contradict this presumption, and show who is 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 Side effects
Effects of a proposed project on other parts of the firm. 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 Safe Harbor
1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.
2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 21E of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995.
Cadence(TM), Acetavance(TM) and Omigard(TM) are trademarks of Cadence Pharmaceuticals, Inc.
Contacts: William R. LaRue SVP & Chief Financial Officer Cadence Pharmaceuticals, Inc. 858-436-1400 Anna Gralinska Director, Investor Relations Cadence Pharmaceuticals, Inc. 858-436-1452 CADENCE PHARMACEUTICALS, INC. (a development stage company) CONDENSED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended March 31, 2008 2007 Operating expenses: 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, 2008 2007 (unaudited) Assets Current assets: 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 Current liabilities: 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
CONTACT: William R. LaRue, SVP SVP S'il Vous Plaît (French: Please)
SVP Senior Vice President
SVP Schweizerische Volkspartei (Swiss People~s Party)
SVP Society of Vertebrate Paleontology
SVP Social Venture Partners
SVP St Vincent de Paul & Chief Financial Officer, +1-858-436-1400, or Anna Gralinska, Director, Investor Relations, +1-858-436-1452, both of Cadence Pharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/