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
 
Date of Report (Date of earliest event reported): August 9, 2017
 
 

 
ANTHERA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in 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:
 
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))
  
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
 

 


 
Item 8.01.
Other Events.
 
On August 9, 2017, Anthera Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that blisibimod has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Immunoglobulin A nephropathy. 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 August 9, 2017
 

 
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: August 9, 2017
 
 
 
Anthera Pharmaceuticals, Inc.
       
 
 
 
 
By:
 
/s/ Craig Thompson
 
 
 
 
 
 
Craig Thompson
 
 
 
 
 
 
President and Chief Executive Officer
(Principal Executive Officer)
 


 
Exhibit Index
 
 
     
Exhibit No.
  
Description
   
99.1
  
Press release dated August 9, 2017
 
 
 

Exhibit 99.1

Anthera Announces FDA Orphan Drug Designation for Blisibimod for the
Treatment of IgA Nephropathy

HAYWARD, Calif., August 9, 2017 (GLOBE NEWSWIRE) – Anthera Pharmaceuticals (Nasdaq:ANTH) today announced that blisibimod has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A nephropathy (IgAN).  Blisibimod targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including IgAN, systemic lupus erythematosus, and others.
 
“We are pleased by the FDA’s decision to designate blisibimod with orphan drug designation,” said Craig Thompson, Chief Executive Officer of Anthera. “There remains a very high need for patients with IgA nephropathy, as no approved therapies currently exist despite the high proportion of patients who progress to end-stage renal disease. We remain optimistic that blisibimod may be a well-tolerated, disease-modifying therapeutic that targets the underlying pathology for IgAN.”

Anthera is currently analyzing the data from the randomized, double-blind, placebo controlled, Phase 2 BRIGHT-SC study of blisibimod in patients with IgA nephropathy (IgAN). After Week 24, patients were given the opportunity to continue blinded treatment for up to 104 weeks, discontinue treatment but continue to be followed, or discontinue from the study. Most patients, 42 of 57, completed at least 60 weeks of evaluation and 21 completed assessments through at least 104 weeks. Anthera anticipates reporting top-line data later this month.
 
IgAN, also known as Berger’s disease is the most common cause of primary glomerulonephritis (acute inflammation of the kidney) worldwide, occurring more frequently in Asia than in Europe or North America. IgAN is characterized by deposition of immune complexes in the kidney, resulting in inflammation, the leakage of blood and protein into the urine, and loss of kidney function. The disease typically progresses slowly but as many as 40-50% of adults will eventually develop end-stage-renal disease and require dialysis or kidney transplant.  There are currently no approved therapies for IgA nephropathy.

 
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. annually. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.
 
About Anthera Pharmaceuticals
 
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency and IgA nephropathy. Additional information on the Company can be found at www.anthera.com.
 


 
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.   Such 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, including but not limited to those set forth in Anthera's public filings with the SEC, including Anthera's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.  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: Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com

For Media Inquiries:
Frannie Marmorstein
rbb Communications
frannie.marmorstein@rbbcommunications.com
305-567-0821

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Source: Anthera Pharmaceuticals, Inc.