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8-K - FORM 8-K - Anthera Pharmaceuticals Inc | f57416e8vk.htm |
Exhibit 99.1
Anthera
Suspends Enrollment and Dosing in PEARL-SC Clinical Trial to Address Reports of Vial Problems
HAYWARD, Calif., November 16, 2010 Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a
biopharmaceutical company developing drugs to treat serious diseases associated with inflammation,
today announced that it has notified the US Food and Drug Administration (FDA) 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 (lupus), due to problems found with 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 Monday
evening 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 (or
SAEs) have been reported to the company in the PEARL-SC trial.
The safety of our patients and the trust of the healthcare professionals involved in our clinical
trials are of the utmost importance to Anthera so we have voluntarily placed PEARL-SC on
hold until we can satisfactorily address the vial cracking that has been reported, said Paul
F.Truex, CEO of Anthera Pharmaceuticals. Getting to the root of this issue and resuming the
clinical program for A-623 is a top priority. We believe that A-623 represents a promising
therapeutic option for patients with autoimmune diseases and remain committed to working as quickly as possible
to resolve this issue and discuss our plans with the FDA. We intend to provide a further update
once those plans are in place.
Anthera
management will host a conference call today, November 16, at 5
pm Eastern Time (2 pm Pacific Time) to discuss todays
announcement. U.S. and Canadian participants may dial (877) 312-8807;
international participants may dial (253) 237-1190.
The conference ID is 26065329. To access the 24-hour audio replay, U.S. and Canadian participants may
dial (800) 642-1687; international participants may dial (706)
645-9291. The conference ID for the replay is 26065329. The
audio replay will be available until November 24, 2010. This conference call will be webcast live
and archived on Antheras website until November 16, 2011, www.anthera.com.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing
products to treat serious diseases associated with inflammation, including cardiovascular and
autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical
programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2 . Elevated
levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute
coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary
artery disease (CAD). Antheras Phase 2 product candidate, A-623, targets elevated levels of
B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated
autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please
visit www.anthera.com.
Safe Harbor Statement
Certain
statements contained in this press release that refer to future events are forward-looking
statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are based on Antheras expectations as of the date of
this press release and are subject to certain risks and uncertainties that could cause actual
results to differ materially as set forth in the Companys public filings with the Securities and
Exchange Commission, including Antheras Quarterly Report on
Form 10-Q for the quarter ended September 30, 2010. Anthera disclaims any intent or obligation to update any forward-looking
statements, whether because of new information, future events or otherwise, except as required by
applicable law.
CONTACTS:
Chris Lowe, CFO of Anthera Pharmaceuticals, Inc., clowe@anthera.com or 510.856.5585
Chris Lowe, CFO of Anthera Pharmaceuticals, Inc., clowe@anthera.com or 510.856.5585
Peter
Rahmer of The Trout Group, prahmer@troutgroup.com or 646.272.8526
Christine Labaree of The Trout Group, clabaree@troutgroup.com or 978.697.8463
Christine Labaree of The Trout Group, clabaree@troutgroup.com or 978.697.8463