Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - Anthera Pharmaceuticals Inc | f57416exv99w1.htm |
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
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 16, 2010
ANTHERA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-34637 | 20-1852016 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 25801 Industrial Boulevard, Suite B, Hayward, California | 94545 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (510) 856-5600
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:
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 8.01 Other Events.
On November 16, 2010, Anthera Pharmaceuticals, Inc. (the “Company”) issued a press release
announcing that it had notified the U.S. Food and Drug Administration that the Company has placed a
voluntary hold on PEARL-SC, the Phase 2b study of A-623 for the treatment of Systemic Lupus
Erythematosus, due to problems found with its product vials. The
Company was recently notified by a single
clinical investigator that a number of vials of clinical product had
experienced structural failure (“cracking”). After a
preliminary inspection of selected product inventory at the site and
at a product storage facility, the Company determined on the evening
of November 15, 2010, that the single site finding was not an
isolated problem. As a result of these findings, patient
enrollment in the PEARL-SC study was immediately suspended and patients currently enrolled in the study
will discontinue dosing while the Company conducts a complete analysis of the
problem. There have been no reports of patient-related side effects or problems with drug
administration that could be attributed to this problem and to date, no serious adverse events have
been reported to the Company in the PEARL-SC trial.
A copy of the press release is filed herewith as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
99.1
|
Press Release, dated November 16, 2010 |
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.
| Date: November 16, 2010 | Anthera Pharmaceuticals, Inc. |
|||
| By: | /s/ Christopher P. Lowe | |||
| Christopher P. Lowe | ||||
| Chief Financial Officer and Vice President of Administration |
||||
Exhibit Index
| Exhibit No. | Description | |
99.1
|
Press Release, dated November 16, 2010 |