Navigation Links
Anthera Pharmaceuticals Reports 2011 Fourth Quarter Financial Results and Provides Clinical Progress Update

HAYWARD, Calif., Feb. 21, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), today announced financial results and business highlights for the quarter ended December 31, 2011.

Financial Results:

Total operating expenses for the fourth quarter ended December 31, 2011 were $28.4 million, as compared to $12.9 million for the same period in 2010. For the 12 months ended December 31, 2011, total operating expenses were $93.1 million, as compared to $35.8 million for the same period in 2010.  Increased operating expenses for the fourth quarter of 2011 and for the full calendar year compared to the same periods in 2010 are primarily due to increased research and development expenses associated with our Phase 2b PEARL-SC clinical study in patients with Systemic Lupus Erythematosus, or lupus, and our VISTA-16 clinical study in patients with Acute Coronary Syndrome, or ACS.

Anthera ended the fourth quarter of 2011 with approximately $67.4 million in cash and cash equivalents and short-term investments.  This is compared to $93.3 million in cash and cash equivalents and short-term investments for the third quarter ended September 30, 2011.

In conjunction with the release of the fourth quarter 2011 financial report, Anthera will host a conference call at 1 p.m. Eastern Time today, February 21, 2012. U.S. and Canadian participants may dial (877) 312-8807; international participants may dial (253) 237-1190.  The Conference ID is 47038854. To access the 24-hour audio replay, U.S. and Canadian participants may dial (855) 859-2056; international participants may dial (404) 537-3406.  The conference ID for the replay is 47038854.  The audio replay will be available until February 28, 2012.

Recent Business Highlights and Upcoming Events:


  • In December 2011, the VISTA-16 Data Safety Monitoring Board (DSMB) met for the fifth time to review the available safety data and recommended the study continue without change.  VISTA-16 is a Phase 3 pivotal clinical study evaluating the benefit of early varespladib treatment in high-risk ACS patients.  As per a Special Protocol Assessment with FDA, the primary endpoint of the VISTA-16 study is a reduction in Major Adverse Cardiovascular Events (MACE) as defined by FDA draft guidance to include cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization.  Details regarding the study can be found at
  • In the fourth quarter of 2011, the VISTA-16 study accrued the requisite one hundred and ninety-three (193) adjudicated primary endpoint events required for the pre-specified interim efficacy analysis.  Subsequent to the end of the fourth quarter, the DSMB scheduled a meeting for the second week in March 2012 to review all available safety data and to conduct the formal interim efficacy analysis.  The interim efficacy analysis plan for the VISTA-16 clinical study allows for a recommendation by the DSMB to stop the study should there be sufficient evidence of overwhelming treatment benefit in the varespladib arm after approximately 193 of the primary events have been accrued.  Overwhelming benefit is defined as a treatment effect in favor of the varespladib arm resulting in a p-value of less than 0.001 (p<0.001).
  • Enrollment in the Phase 2b PEARL-SC clinical study was completed (N=547) in the fourth quarter. The PEARL-SC study is examining the therapeutic benefit of monthly and weekly subcutaneous doses of blisibimod in patients with lupus.  The primary endpoint of PEARL-SC requires patients to demonstrate a greater than or equal to five (>/=5) point reduction in the SELENA-SLEDAI clinical assessment score, no worsening in physician global assessment, and no new BILAG A or two new BILAG B organ domain scores.  Details regarding the study can be found at
  • After the completion of enrollment in the PEARL-SC study, an independent statistician confirmed that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B-cells. Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. These findings are consistent with data from previous clinical studies of blisibimod. The Company remains blinded to primary efficacy data.
  • Subsequent to the end of the fourth quarter, the 350th enrolled patient in the PEARL-SC study reached the 24-week time point, triggering an interim efficacy analysis to be conducted in the first week of March 2012.  The interim efficacy analysis plan for PEARL-SC allows for a recommendation by the independent statistician to stop the study should there be a statistically significant improvement in the pooled blisibimod arm versus the pooled placebo treatment arm (p<0.0108) at the 24-week primary efficacy endpoint and at least one other time point, including week 16, 20 or 28, using the SLE responder index.  The SLE responder index is a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of five (5) points or greater, no increase in a physician's global assessment of more than 0.3 points, and no new BILAG A or two new BILAG B organ domain flares.  In conjunction with the interim analysis, the DSMB will meet for the fourth time to evaluate all available patient safety data.

  • Manufacturing

  • The Company completed its second 3,000 liter blisibimod manufacturing campaign.  Both lots have passed all release testing having met pre-defined specifications and were released for clinical use in the PEARL-SC clinical study. The data from these GMP campaigns were submitted to FDA as a part of the Comparability Plan for blisibimod.

  • Management

  • Anthera announced the promotion of Dr. Debra Odink to the role of Chief Technology Officer and Senior Vice President.  Dr. Odink has served as Anthera's Senior Vice President of Pharmaceutical Research and Development since 2005.  Dr. Odink assumes the responsibility of overseeing all aspects of clinical pharmacology, non-clinical sciences product and process development activities.

  • *SELENA-SLEDAI -- Safety of Estrogen in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative, weighted index of systemic lupus erythematosus disease activity.

    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 three late stage clinical products: varespladib methyl (A-002), A-001 and blisibimod (A-623).  Varespladib methyl (A-002) and A-001 are designed to inhibit a novel enzyme target known as secretory phospholipase A2 (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. Blisibimod targets elevated levels of B-lymphocyte stimulator (BAFF) which have been associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus) and rheumatoid arthritis.  

    Safe Harbor Statement

    Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project" or similar statements, 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 Anthera's 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 Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2011. 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.

    CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., or 510-856-5586.ANTHERA PHARMACEUTICALS, INC.A Development Stage CompanySTATEMENTS OF OPERATIONS(unaudited)(in thousands except share and per share data)Three Months Ended December 31,Twelve Months Ended December 31,2011201020112010OPERATING EXPENSE:  Research and development

    85, 281$
    29,457  General and administrative

    1,5972,0577,8576,301Total operating expense

    28,42912,94993,13835,758LOSS FROM OPERATIONS:

    (28,429)(12,949)(93,138)(35,758)OTHER INCOME (EXPENSE):Other income/ (expense)

    185(91)606(15)Interest expense(912)(2,803)(845)Warrant mark to market adjustment

    ———(3,796)Total other income (expense)

    (727)(91)(2,197)(4,656)NET LOSS

    $  (29,156)$   (13,040)$  (95,335)$   (40,414)Net loss per share--basic and diluted

    (1.76) Weighted-average number of shares used in
    per share calculation-- basic and diluted

    40,916,66632,828,69737,417,77522,909,802ANTHERA PHARMACEUTICALS, INC.A Development Stage CompanyBALANCE SHEET DATA(unaudited)(in thousands except share amounts)December 31,
    2011December 31,
    2010Cash and cash equivalents

    40,030Short term investments

    23,351Total assets

    5,263Total current liabilities, excluding current portion of notes payable

    8,005Total notes payable

    8212;Deficit accumulated during development stage

    $   (200,979)$   (105,644)Total shareholders' equity

    57,258Common shares outstanding


    SOURCE Anthera Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
    2. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
    3. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    4. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
    5. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
    6. DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    7. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
    8. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
    9. Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    10. Antheras Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
    11. Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
    Post Your Comments:
    (Date:10/9/2015)... REDWOOD CITY, Calif. , Oct. 9, 2015 ... a presentation will be made at the annual European Society ... th to October 14 th , 2015 at the ...  The annual EuSEM is the largest meeting of emergency medicine ... and 90 countries represented. Data from the previously ...
    (Date:10/9/2015)... Oct. 9, 2015 Ansun BioPharma announced a ... of America ) regarding the compassionate use of DAS181 ... a respirator who was co-infected with influenza and parainfluenza ... of therapy, O 2 requirement was reduced and ... able to go off the respirator on day 5. ...
    (Date:10/9/2015)... , Schweiz, October 9, 2015 Der ... Dr.   Yutaka Kondo und Dr.   Junko Takita ...   2015 " geht an Dr.   Yutaka ... Der " JCA-Mauvernay Award   2015 ... Dr.   Junko Takita    ™ , das ...
    Breaking Medicine Technology:
    ... Nov. 9, 2011 BioSpecifics Technologies Corp. (NASDAQ: ... class collagenase-based products marketed as XIAFLEX® in the U.S. ... Tom Wegman, will present at the upcoming Lazard Capital ... Wednesday, November 16, 2011 in New York, NY.   ...
    ... 9, 2011 NeuroDerm , Ltd. ... and pharmacokinetic trial of ND0611, administered as an adjunct ... or Stalevo ® , in patients with advanced Parkinson,s ... sub-cutaneously via a dermal patch to increase the bioavailability ...
    Cached Medicine Technology:
    (Date:10/10/2015)... York, NY (PRWEB) , ... October 10, 2015 , ... ... some alarming numbers on the growth of cybercrime costs for US companies. The New ... on Tuesday, October 6th. With averages showing increases hovering around 20% among the companies ...
    (Date:10/10/2015)... , ... October 10, 2015 , ... Isabel Healthcare will ... , On the heels of the release of the Institute of Medicine’s latest report ... their integration with Cerner solutions that assist healthcare providers and consumers to potentially reduce ...
    (Date:10/9/2015)... ... October 09, 2015 , ... The American Osteopathic ... for Graduate Medical Education J. Michael Finley, DO, as the recipient of the ... for his impact on graduate medical education opportunities for osteopathic residents, and his ...
    (Date:10/9/2015)... ... 2015 , ... A new health tool that helps identify if a sore ... ) – just in time for the cold and flu season, which the ... many in the U.S., the real start of cold/flu season is the start of ...
    (Date:10/9/2015)... ... October 09, 2015 , ... Dentist in Huntington ... orthodontic system that uses clear, plastic aligners. This alternative to braces has become ... which allow patients to complete treatment in privacy. Additionally, Invisalign aligners are removable, ...
    Breaking Medicine News(10 mins):
    ... serious problem that can often be fatal. Methadone has ... addicts. However, the major concern in treating heroin addicts ... is one reason methadone therapy is usually only given ... that an alternative drug therapy combined with psychosocial treatment ...
    ... researchers are currently testing the safety of hypothermia ... injury. Hypothermia treatment has been shown to be ... but its effectiveness in treating children with traumatic ... decreases inflammation, excitotoxicity (excessive neurotransmitters released with injury ...
    ... of skin cancer and it has been shown through previous ... sunlight, whose UV rays cause damage to DNA that triggers ... are more prone than others to melanoma. Researchers have now ... people with melanoma that those with fair skin// have lowered ...
    ... Affective Disorder(SAD) is not all that well understood, but ... sunlight in the winter months. Winter depression involves suffering ... days get longer and nights get shorter. Other SAD ... sleeping for longer than usual. Researchers have now found ...
    ... hospital in Kolkatta, India recently received a patient, a two-month-old ... suffering from a rare disease caused due to a deficiency ... of 10 million children. Doctors said that the baby was ... On detection the baby, a boy child, was found to ...
    ... time to its ultraviolet rays, has always been said to be ... shown that even moderate sun exposure can result in moles that ... to sun has been shown as the main risk factor for ... rarest type of skin cancer, is much weaker. It has however, ...
    Cached Medicine News:
    ... has the highest g-force ever. But optimal ... force. Optima MAX combines maximum force, capacity, ... performance that's worlds apart from any other ... and enhanced efficiency, Optima takes productivity to ...
    ... of generating 694,000 x g ... rpm, Beckman Coulter's Optima L-90K ... more separations in less time. ... with a broad range of ...
    ... The Dimension Xpand integrated chemistry ... compact footprint to the smaller laboratory. ... the Dimension Xpand integrated chemistry system ... for the low-volume testing environment, in ...
    ... Dade Behring's Dimension clinical chemistry integrated systems ... Flex reagent cartridge, the power of the ... innovation of the heterogeneous module to meet ... innovation and broad test menus, the systems ...
    Medicine Products: