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
Date of report (Date of earliest event reported): December 6, 2006
Auxilium Pharmaceuticals, Inc.
(Exact Name of Registrant Specified in Charter)
Delaware | 000-50855 | 23-3016883 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
40 Valley Stream Parkway Malvern, PA | 19355 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (484) 321-5900
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:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
On December 6, 2006, Auxilium Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has temporarily suspended the dosing of patients in the Company’s ongoing phase III trials for AA4500 for the treatment of Dupuytren’s contracture in response to a visual appearance failure of the lyophilized material in some vials of AA4500 for use in the clinical trials. The Company is conducting an investigation to determine the root cause of this failure and believes that it is likely related to the higher than expected moisture content within the vial. Based on tests conducted, the Company has excluded container closure as a cause and believes that the issue is related to the lyophilization process and/or equipment. The issue was identified as part of routine ongoing stability testing. The Company will hold a conference call to discuss this matter on December 7, 2006 at 9:00 a.m. Eastern Time.
The foregoing is qualified in its entirety by the text of the press release attached as Exhibit 99.1 hereto and incorporated herein by reference. All readers are encouraged to read the entire text of the press release attached hereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description of Exhibit | |
99.1 | Press release, dated December 6, 2006, issued by Auxilium Pharmaceuticals, Inc. |
SIGNATURE
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.
AUXILIUM PHARMACEUTICALS, INC. | ||||
Date: December 7, 2006 | By: | /s/ James E. Fickenscher
| ||
James E. Fickenscher | ||||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. | Description of Exhibit | |
99.1 | Press release, dated December 6, 2006, issued by Auxilium Pharmaceuticals, Inc. |