UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

Cadence Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-33103		41-2142317
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

12481 High Bluff Drive, Suite 200
San Diego, California 92130
(Address of principal executive offices, including zip code)

(858) 436-1400
(Registrant’s telephone number, including area code)

Not applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Item 7.01 Regulation FD Disclosure

          Cadence Pharmaceuticals, Inc. (“Cadence”) hosted a conference call on July 30, 2007, at 9:00 a.m. Eastern time regarding its discussions with the U.S. Food and Drug Administration on Cadence’s proposed increase in the number of patients to be enrolled in the ongoing Phase III clinical trial of its experimental product candidate, Omigard™ (omiganan pentahydrochloride 1% aqueous gel), and the anticipated financial impact of this increase.

     The conference call transcript is attached hereto as Exhibit 99.1 and is incorporated herein by reference. A webcast replay of the conference call will remain available on Cadence’s website, www.cadencepharm.com, for fifteen days.

     The information in this Current Report on Form 8-K, including the transcript attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

     By filing this Current Report on Form 8-K and furnishing this information, Cadence makes no admission as to the materiality of any information in this report. The information contained in the transcript is summary information that is intended to be considered in the context of Cadence’s other filings with the SEC and other public announcements that Cadence makes, by press release or otherwise, from time to time. Cadence undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosure.

     Cadence cautions you that statements included in this report, including the transcript attached hereto as Exhibit 99.1, that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding: the anticipated completion of the increased enrollment of patients in the ongoing Phase III clinical trial of Omigard; the related projected financial impact; and the potential for filing a new drug application, or NDA, for Omigard and the timing of any such filing. 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 report due to the risks and uncertainties inherent in Cadence’s business, including, without limitation: Cadence’s ability to enroll sufficient patients to complete the pending Phase III clinical trial of Omigard; potential delays in the completion of the trial; the adequacy of the trial design for the pending Phase III clinical trial of Omigard to generate data that are deemed sufficient by regulatory authorities to support potential regulatory filings, including an NDA, for Omigard; the potential for Omigard, or Cadence’s other product candidate, IV APAP, an intravenous formulation of acetaminophen, to receive regulatory approval for one or more indications on a timely basis or at all; unexpected adverse side effects or inadequate therapeutic efficacy of IV APAP or Omigard that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for IV APAP or Omigard; the market potential for pain, fever, local catheter site infections and other target markets, and Cadence’s ability to compete; Cadence’s ability to raise sufficient capital; and other risks detailed in Cadence’s prior press releases as well as in Cadence’s 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 report 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.

Item 9.01 Financial Statements and Exhibits

                         (d) Exhibits.

		Exhibit
		Number				Description of Exhibit
			99.1			Conference Call Transcript, dated July 30, 2007

SIGNATURES

          Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: July 31, 2007

EXHIBIT INDEX

Exhibit
Number		Description of Exhibit
99.1		Conference Call Transcript, dated July 30, 2007

Exhibit 99.1

CADENCE PHARMACEUTICALS, INC.

EVENT:		CONFERENCE CALL
TOPIC:		AGREEMENT WITH FDA ON INCREASED ENROLLMENT IN PHASE III CLINICAL TRIAL OF OMIGARD
DATE:		MONDAY, JULY 30, 2007
TIME:		9:00 AM ET
SPEAKERS:		THEODORE R. SCHROEDER PRESIDENT & CHIEF EXECUTIVE OFFICER
		WILLIAM R. LARUE SENIOR VICE PRESIDENT & CHIEF FINANCIAL OFFICER
		JAMES B. BREITMEYER, M.D. EXECUTIVE VICE PRESIDENT, DEVELOPMENT & CHIEF MEDICAL OFFICER
SOURCE:		WEBCAST
LENGTH:		11 MINUTES

MANAGEMENT DISCUSSION

OPERATOR: Good morning, and welcome to the Cadence Pharmaceutical Conference Call.

At this time I would like to inform you that this conference is being recorded and that all participants are in a listen-only mode. At the request of the company we will open the conference up for questions and answers after the presentation. Should you

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have any problems during the call, please press star 0 for the conference call operator. Our first speaker is Bill LaRue, Senior Vice President and Chief Financial Officer of Cadence Pharmaceuticals. Go ahead, Bill.

William L. LaRue, Senior Vice President and Chief Financial Officer

Good morning. Before we get started, I would like to remind everyone that statements made during this conference call that are not a description of historical facts are forward-looking statements. For example, statements about our expectations, beliefs, plans, objectives, assumptions, or future events or performance are not historical facts and are all forward-looking statements. Such forward-looking statements, which may be identified by the use of words or phrases such as “believe,” “may,” “anticipate,” or “expect” and “other risks,” are based upon our current expectations, but do not represent historical fact. You can also find detailed risk factors in our Securities and Exchange Commission filings. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update the information presented in this conference call to reflect events or circumstances after the date hereof. This caution is made under

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the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

This morning we issued a press release announcing our agreement with the FDA to increase the number of patients in the Omigard Phase III clinical trial. If anyone has not seen that news release, you can access it on our website at www.cadencepharm.com. Additionally, this conference call is being webcast through the company’s website and will be archived there for future reference.

On the call with me today is Ted Schroeder, our President and CEO. Dr. Jim Breitmeyer, Cadence’s Executive Vice President of Development and Chief Medical Officer, is also here and available to answer questions later in the call.

I will now turn the call over to Ted.

Theodore R. Schroeder, President and Chief Executive Officer

Thank you, Bill, and good morning, everyone. Thank you for joining us today to discuss FDA’s agreement with Cadence’s plan to increase patient enrollment in our ongoing Phase III clinical trial of Omigard from our original target of 1,250 patients to 1,850. As you know, we are evaluating Omigard, a topical

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antimicrobial, for the prevention of catheter-related infections in the hospital setting in a study called the Central Line Infection Reduction Study, or CLIRS.

In late April we announced our intent to propose to the FDA a sample size increase in the CLIRS trial to maintain the statistical power of the study following a reanalysis of data from the initial Phase III trial. Since the CLIRS trial is being conducted under a Special Protocol Assessment with the FDA, we had to obtain the FDA’s concurrence with our proposal to increase the number of enrolled patients.

The reanalysis was performed as part of our standard procedure for analyzing previously collected data to prepare a final report of the study for a New Drug Application. Our reanalysis used a stricter definition of “local catheter site infections” and indicated a statistically significant reduction of local catheter site infections of 42 percent as compared to the approximately 49 percent reduction in the previous analysis initially conducted by our licensor.

The apparent decrease in the treatment effect in the prior study prompted us to review the statistical design of the CLIRS trial. Based on the statistical review, we believe that adding 600

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patients to the total enrollment is prudent in order to maintain the statistical power of the study and will allow us a better opportunity to achieve a positive final result.

We are pleased to report that the FDA has concurred with our proposal, and we now anticipate that we will complete enrollment of our new goal of 1,850 patients in the second quarter of 2008, versus our original enrollment completion estimate of the second half of 2007. If the results of this study are positive, we expect to submit a New Drug Application for Omigard in the first half of 2009.

In order to offset the extended duration of the trial, we have focused significant efforts over the past several months on accelerating the enrollment of patients in the CLIRS trial. We are also pleased to report that we completed the enrollment of the original target of 1,250 patients in June, a full two months ahead of schedule.

I would like to take this opportunity to thank the clinicians and support staff at our Omigard clinical sites, as well as our internal project management team, for their dedicated effort and commitment, which helped make this achievement possible. Reaching our original patient enrollment goal ahead of plan also

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supports our belief that there is a substantial unmet medical need for Omigard as hospitals seek new ways to prevent local catheter site infections.

The estimated 325,000 annual catheter-related bloodstream infections in the U.S. result in an alarming 40,000 to 80,000 deaths annually, a mortality rate similar to that of prostate cancer. Infections also lead to extended hospital stays and millions of dollars in extra costs for hospitals. We believe that there is an urgent need to improve on the current standard of care in addressing this problem.

With that, I would like to turn the call over to our Chief Financial Officer, Bill LaRue, to discuss the anticipated financial impact of the increased patient enrollment on Cadence’s operating results. Bill.

William L. LaRue, Senior Vice President and Chief Financial Officer

Thank you, Ted. As a result of the increased Omigard trial enrollment from 1,250 to 1,850 patients, and additional development expenditures associated with the Omigard program, we expect our total operating expenses for the full year 2007 to range from $57 million to $60 million, including an estimated $4 to $5 million in non-cash, stock-based compensation expenses.

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This compares to our previous operating guidance of $49 million to $53 million. We anticipate that our cash at the end of 2007 will be in the $35 million to $38 million range. As of the end of the first quarter we held cash and cash equivalents of $77.4 million.

I will now turn the call back over to Ted for final comments.

Theodore R. Schroeder, President and Chief Executive Officer

Thanks, Bill. Before we open the call to questions, I’d like to take this opportunity to also mention that, on July 18, 2007, we signed a development and supply agreement with Baxter Healthcare Corporation for the completion of pre-commercialization manufacturing development activities and the manufacture of commercial supplies of finished drug product for our other late-stage clinical product candidate, intravenous acetaminophen, or IV APAP. As you know, we are currently conducting a Phase III clinical trial of IV APAP for the treatment of post-operative pain following gynecological surgery, and we plan to conduct six additional clinical trials of IV APAP to support the filing of an NDA for IV APAP for the treatment of acute pain and fever in adults and children. We plan to announce the results of our IV

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acetaminophen trials in the first half of 2008 and to submit the NDA package in the second half of 2008.

In closing, we are very pleased with our progress and the rate of patient enrollment in both of our clinical programs. With that, I will turn the call back to the operator to open the lines for questions.

QUESTION AND ANSWER

OPERATOR: Thank you, Mr. Schroeder. The question-and-answer session will begin at this time. If you are using a speakerphone, please pick up the handset before pressing any numbers. Should you have a question, please press star and the number 1 on your pushbutton telephone. If you wish to withdraw your question, please press star and the number 2. Your questions will be taken in the order they are received.

Please stand by for your first question. First question comes from Greg Fraser with Merrill Lynch.

GREG FRASER: Good morning, guys.

THEODORE SCHROEDER: Good morning, Greg.

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GREG FRASER: Are you still adding trial sites for Omigard? Or do you believe that the additional patients can be enrolled at the existing sites?

JAMES BREITMEYER: This is Jim Breitmeyer, Greg. We are adding trial sites. We have just lined up some additional U.S. investigators, and we have added Germany as a third European country to augment enrollment from Spain and France. And we expect the first German patient to enroll in the next few weeks.

GREG FRASER: Okay. And other than the number of patients, were there any other changes made to the protocol?

JAMES BREITMEYER: Some very minor technical changes that have to do with the analysis of data after the study is over.

GREG FRASER: So that there is nothing that was done that would cause any problems for the patients that have already completed the study?

JAMES BREITMEYER: No. We believe that the existing patients are completely evaluable under the new – under the amended protocol.

GREG FRASER: Okay, thank you.

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OPERATOR: As a reminder, ladies and gentlemen, if you do have a question, please press “star 1” on your pushbutton telephone at this time.
THEODORE SCHROEDER: Operator, any addition questions?

OPERATOR: At this time there are no further questions, so I’ll turn the conference back to Mr. Schroeder to conclude.

Theodore R. Schroeder, President and Chief Executive Officer

Well, thank you, everyone, for joining us today. And this concludes our call for today. Thank you.

OPERATOR: Ladies and gentlemen, this concludes our conference call for today. All parties may now disconnect.

PRESS RELEASE:

http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=257042

END AUDIO

ELAINE FARRIS • TRANSCRIBED 07/30/07 • 760-248-2070