-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Dv0DTPIuDotyRVZBeboTW/Ejx1G1hvR2W2n7FPagvTOhLLvtGjsqf7lCiw15KDXF UUs0JQsrBlqpzvg3g2oIeQ== 0001104659-08-035789.txt : 20080527 0001104659-08-035789.hdr.sgml : 20080526 20080527080021 ACCESSION NUMBER: 0001104659-08-035789 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080527 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080527 DATE AS OF CHANGE: 20080527 FILER: COMPANY DATA: COMPANY CONFORMED NAME: FAVRILLE INC CENTRAL INDEX KEY: 0001285701 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330892797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51134 FILM NUMBER: 08859451 MAIL ADDRESS: STREET 1: 10421 PACIFIC CENTER COURT STREET 2: STE 150 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a08-15310_18k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): May 27, 2008

 

FAVRILLE, INC.

(Exact Name of Registrant as Specified in Charter)

 

DELAWARE

 

000-51134

 

33-0892797

(State or Other Jurisdiction
of Incorporation)

 

(Commission File Number)

 

(I.R.S. Employer
Identification No.)

 

 

 

 

 

 

 

10445 PACIFIC CENTER COURT

 

 

 

 

SAN DIEGO, CALIFORNIA

 

92121

 

 

(Address of Principal Executive Offices)

 

(Zip Code)

 

(858) 526-8000

(Registrants telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K 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 CRF 240.13e-4(c))

 

 



 

Item 8.01. Other Events.

 

On May 27, 2008, the registrant issued a press release announcing results from its Phase 3 registration trial of Specifid™ following Rituxan® in patients with follicular B-cell non-Hodgkin’s lymphoma (NHL). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d)       Exhibits

 

99.1        Press release of the registrant dated May 27, 2008.

 

2



 

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.

 

 

FAVRILLE, INC.

 

 

 

By:

/s/ Tamara A. Seymour

Date: May 27, 2008

 

Tamara A. Seymour

 

 

Chief Financial Officer

 

3



 

INDEX TO EXHIBITS

 

99.1     Press release of the registrant dated May 27, 2008.

 

4


EX-99.1 2 a08-15310_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Company Contacts:

 

 

Tamara A. Seymour

 

Pete De Spain

Chief Financial Officer

 

Director, Investor Relations

Favrille, Inc.

 

& Corporate Communications

(858) 526-8035

 

Favrille, Inc.

tseymour@favrille.com

 

(858) 526-2426

 

 

pdespain@favrille.com

 

Favrille Announces Results from Phase 3 Registration Trial of Specifid in Patients with
Follicular B-Cell Non-Hodgkin’s Lymphoma

 

Results Fail to Show Statistically Significant Improvement in Primary Endpoint, Time to
Progression, Compared to Control

 

San Diego – May 27, 2008 – Favrille, Inc. (Nasdaq: FVRL) today announced results from the Company’s Phase 3 registration trial of Specifid™ following Rituxan® in patients with follicular B-cell non-Hodgkin’s lymphoma (NHL).

 

Analysis of time to progression (TTP), the primary endpoint in the trial, failed to show a statistically significant improvement in the treatment arm, Specifid plus Leukine® (sargramostim, GM-CSF) following Rituxan, compared to the control arm, placebo plus Leukine following Rituxan. Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.

 

The safety profile was comparable between the two arms and consistent with what has been observed in previous Specifid trials. Most adverse events reported in the trial were of low grade.

 

“We are clearly very disappointed with the data from this trial, particularly on behalf of the patients and their families,” said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. “Based on these results, we are discontinuing development of Specifid and are currently evaluating steps to conserve cash and recognize value on our assets. We wish to thank all of our employees and the patients, clinical investigators and trial coordinators for their support and dedication.”

 

About the Phase 3 Registration Trial

 

Favrille initiated its Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid for follicular B-cell NHL in July 2004. The Company completed enrollment in January 2006 with 349 patients randomized into the trial. The trial was open to both treatment-naïve and previously treated patients, ultimately enrolling a much larger treatment-naïve population (78%). Patients were randomized at a one-to-one ratio to receive either Specifid or placebo following a standard course of Rituxan. The trial was conducted at 67 centers in the U.S.

 



 

Conference Call and Webcast

 

Favrille’s management team will host a conference call today at 8:30 a.m. Eastern Time to discuss the information contained in this press release. A live audio webcast will be available on the Investor Relations section of the Company’s web site at www.favrille.com. Alternatively, callers may participate in the conference call by dialing (866) 831-6267 or (617) 213-8857, passcode 99549869. A telephone replay of the call will also be available for 48 hours. The telephone replay can be accessed by dialing (888) 286-8010 or (617) 801-6888, passcode 20389415.

 

About Favrille, Inc.

 

Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system.

 

# # #

 

Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, references to Favrille’s product candidates, proprietary technologies and research and clinical development programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to Favrille’s ability to continue its operations, conserve cash or recognize value on our assets and additional risks discussed in Favrille’s filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

 

2


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