Navigation Links
Anthera Pharmaceuticals Reports 2011 First Quarter Financial Results and Operational Update
Date:5/3/2011

HAYWARD, Calif., May 3, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), today announced financial results and business highlights for the quarter ended March 31, 2011.

Financial Results:

Total operating expenses for the first quarter ended March 31, 2011 were $18.7 million, as compared to $6.5 million for the same period in 2010. The increased operating expenses in the first quarter of 2011 were driven by expenses related to site initiations and the active enrollment of patients in our Phase 3 VISTA-16 study (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks), which is an event driven study in Acute Coronary Syndrome (ACS) patients studying the benefit of varespladib anti-inflammatory treatment in high risk patients. In addition, the increased manufacturing expenses related to the development of A-623, our large molecule inhibitor of BAFF, and the accelerating enrollment of Anthera's Phase 2b study, PEARL-SC (A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A623 AdministRation in Subjects with Systemic Lupus Erythematosus) at up to 90 clinical sites in up to 12 countries contributed to the increased expense. The quarterly results also reflect the previously anticipated increase in professional services and other costs associated with operating as a public company.

Anthera ended the first quarter of 2011 with approximately $78.5 million in cash and cash equivalents and short-term investments, which includes approximately $25.0 million of gross proceeds received from a term loan which closed on March 25, 2011. This is compared to $63.4 million in cash and cash equivalents and short-term investments for the fourth quarter ended December 31, 2010.

Recent Business Highlights and Upcoming Events:

Clinical

  • Enrollment and site initiations continue according to the Company's estimated timelines in the PEARL-SC study.  Active enrollment is underway in the following countries: United States, Mexico, Peru, Chile, the Philippines, Argentina and Colombia. PEARL-SC is examining the therapeutic benefit of A-623, which utilizes a subcutaneous formulation and modulates both soluble and membrane-bound BAFF in patients with systemic lupus erythematosus (lupus). The primary endpoint of the PEARL-SC study is an SLE responder index (SRI). Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681.
  • The PEARL-SC open label extension protocol has been submitted to FDA. This would allow Anthera to capture important long term safety data and optimize enrollment by giving study subjects an option to continue participation on active therapy beyond the PEARL-SC duration.
  • In the Phase 3 VISTA-16 study, enrollment surpassed the 1000 patient threshold during the first quarter, triggering a pre-defined, blinded biomarker analysis conducted by an independent statistician. The statistician examined four predefined biomarkers of cardiovascular risk and one composite responder index including sPLA2, IL-6, CRP, LDL-C and a composite analysis comparing the proportion of patients achieving an LDL-C < 70 and a CRP < 1. Subsequent to the end of the first quarter, the Company announced a favorable outcome from the biomarker analysis. The VISTA-16 clinical study is designed to reduce inflammation and the risk of subsequent secondary Major Adverse Cardiovascular Events (MACE) in high-risk patients following an ACS. Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01130246. The next substantial review of clinical safety and efficacy data is planned once 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint.

  • Manufacturing

  • The Company initiated pilot scale manufacturing of A-623 and has established process parameters for the purification of small-scale fermentation.
  • The Company has submitted the first of three A-623 Comparability Plans to the US FDA - a key step in ensuring adequate drug supply for Phase 3 and expanded indications.

  • Management

  • Peter Thompson, M.D., was appointed to Anthera's Board of Directors during the quarter.  Dr. Thompson is a venture partner with OrbiMed and is the founder and Managing Director of Strategicon Partners, an investment and management services company. In 2009, Dr. Thompson retired as the Chief Executive Officer and Chairman of Trubion Pharmaceuticals, which he co-founded. He is also the former Vice President and General Manager of Chiron Informatics and held various executive positions at Becton Dickinson.

  • 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. A-002 (Varespladib Methyl) and A-001 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 (ACS) and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). A-623 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. For more information, please visit www.anthera.com.

    Safe Harbor Statement

    Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. 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 the Company's public filings with the Securities and Exchange Commission, including Anthera's Annual Report on Form 10-K for the year ended December 31, 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.

    CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510-856-5586.ANTHERA PHARMACEUTICALS, INC.A Development Stage CompanySTATEMENT OF OPERATIONS(unaudited)Three Months Ended March 31,20112010OPERATING EXPENSE:Research and development

    $
    ,316,758$
    5,241,814General and administrative

    2,339,8821,224,110Total operating expense

    18,656,6406,465,924LOSS FROM OPERATIONS:

    (18,656,640)(6,465,924)OTHER INCOME (EXPENSE):Other expense and interest income, net

    90,935(4,637,868)Total other income (expense)

    90,935(4,637,868)NET LOSS

    $  (18,565,705)$  (11,103,792)Net loss per share--basic and diluted

    $
    (0.56)$
    (0.83)Weighted-average number of shares used in
    per share calculation-- basic and diluted

    32,895,15213,344,231ANTHERA PHARMACEUTICALS, INC.A Development Stage CompanyBALANCE SHEET DATA(unaudited)March 31,
    2011December 31,
    2010Cash and cash equivalents

    $
    ,557,789$
    40,029,972Short term investments

    $
    ,982,185$
    23,350,922Total assets

    $
    81,445,375$
    5,263,062Accounts payable

    $
    7,664,486$
    3,791,693Accrued clinical trial expense

    $
    8,159,476$
    3,136,786Total current liabilities

    $
    ,770,711$
    8,005,382Total notes payable

    $   23,719,801$
    8212;Deficit accumulated during development stage

    $ (124,209,472)$ (105,643,767)Total shareholders' equity

    $
    40,954,863$
    57,257,680Common shares outstanding

    32,909,91432,853,032
    '/>"/>

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

    Related medicine technology :

    1. Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
    2. Anthera Announces Conference Call to Discuss Analytical Method and Timing of Upcoming VISTA-16 Biomarker Analysis
    3. Anthera Pharmaceuticals Names Lawrence Rosania as Vice President of Global Regulatory Affairs and Compliance
    4. Dr. Peter Thompson Joins Anthera Pharmaceuticals Board of Directors
    5. Anthera Pharmaceuticals Selects the Merck BioManufacturing Network as Manufacturing Supplier for A-623, Antheras Investigational Novel Peptibody Agent
    6. Anthera Announces Update Call Regarding Vial Problems
    7. Anthera Pharmaceuticals Reports 2010 Third Quarter Financial Results and Operational Update
    8. Anthera Announces Third Quarter 2010 Financial Report and Conference Call
    9. Anthera Pharmaceuticals Announces Pricing of $31.5 Million PIPE Financing
    10. Anthera Pharmaceuticals to Present at Deutsche Bank Securities 35th Annual Health Care Conference
    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:
    *Name:
    *Comment:
    *Email:
    (Date:9/5/2017)... , Sept. 5, 2017  Just 18 months ... Insight is pleased to announce the appointment of three ... Tammy Wynne , Dominic Jones-Phillips and ... industry. Tammy ... team of market access writers. She has over ten ...
    (Date:9/1/2017)... 2017  Bayer will present the latest research from across ... Oncology (ESMO) 2017 Congress, September 8-12 in Madrid, ... and clinical data on Bayer,s marketed portfolio and late-stage compounds ... "We value the opportunity ... research at ESMO," said Carsten Brunn , Head of ...
    (Date:8/28/2017)... -- Hill-Rom Holdings, Inc. (NYSE: HRC), will present at the ... in New York . John Greisch ... present at 11:05 a.m. Eastern Time. The ... A recorded replay will be available one hour after the ... About Hill-Rom Holdings, Inc. ...
    Breaking Medicine Technology:
    (Date:9/19/2017)... ... 2017 , ... The Lymphoma Research Foundation (LRF) – the ... the lymphoma community through a comprehensive series of education programs, outreach initiatives and ... Swirl: A Wine Tasting Event series on Thursday, October 26, 2017. Hosted at ...
    (Date:9/19/2017)... ... 19, 2017 , ... The American College of Lifestyle ... recently formed Corporate Roundtable, a group of individuals and organizations whose collective vision ... Canyon Ranch is a unique collection of lifestyle-based immersion vacation settings and programs ...
    (Date:9/19/2017)... (PRWEB) , ... September 19, 2017 , ... ... issued a rallying cry to Americans to watch for the discomforts and hidden ... young athletes to senior citizens, everyone is at risk for developing fungal infections ...
    (Date:9/19/2017)... ... September 19, 2017 , ... Leonard I. Linkow, DDS, DMSC, sets ... (published by Xlibris on July of 2014). This book details the recent advances and ... approaches that benefit people who have lost all of their natural teeth . ...
    (Date:9/19/2017)... Va (PRWEB) , ... September 19, 2017 , ... The ... the use of health IT to create efficiencies in healthcare information exchange and a ... the release of their latest industry white paper, entitled Barriers to Adoption of ...
    Breaking Medicine News(10 mins):