Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Porcine Origin in People With Cystic Fibrosis

Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Porcine Origin in People With Cystic Fibrosis

HAYWARD, CA, Oct. 2, 2015 – Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the initiation of the SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in People With Cystic Fibrosis) Phase 3 clinical study evaluating the efficacy and safety of Sollpura® (liprotamase), a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency (EPI).

Study to enroll approximately 130 patients with exocrine pancreatic insufficiency
More than 50 clinical sites around the United States and Europe are expected to participate
Anthera to host reception at the North American Cystic Fibrosis Conference to discuss the SOLUTION program.

Anthera Announces $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Development of Sollpura – a Novel Enzyme Therapy

HAYWARD, Calif., March 19, 2015 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced it has received an award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of Anthera’s novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase). Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation.

Liprotamase is an investigational soluble, stable and non-porcine enzyme therapy intended for people with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI) due to Cystic Fibrosis and other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas. According to the Cystic Fibrosis Foundation, about 90 percent of people with cystic fibrosis have pancreatic insufficiency and need to take pancreatic enzymes with every meal and most snacks in order to absorb vital nutrients.

Anthera Pharmaceuticals Announces Completion of Interim Analysis from Phase 3 Trial with Blisibimod for IgA Nephropathy

-BRIGHT-SC study passes futility analysis and will continue to completion
-Primary efficacy analysis data expected in second half of 2016
-Feedback from European Medicines Agency incorporated into final study design

HAYWARD, Calif., March 16, 2015 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), in collaboration with its partner Zenyaku Kogyo Co., Ltd. today announced that the BRIGHT-SC study of blisibimod in patients with IgA nephropathy (IgAN) should continue to completion as planned. This follows the successful completion of an interim futility analysis, conducted by an independent statistician, which evaluated several important biomarkers of renal disease in patients who had completed at least 8 weeks of treatment.

Anthera Pharmaceuticals Announces Acquisition of Sollpura® (liprotamase) for Exocrine Pancreatic Insufficiency From Eli Lilly and Company

Anthera to Form a New Subsidiary, Alkira Therapeutics, to Assume All Development Activities and Registration Activities as a Subsidiary of Anthera
HAYWARD, Calif., July 14, 2014 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced that it has acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”) from Eli Lilly and Company. Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.

Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod

 
HAYWARD, Calif., June 24, 2013 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.

Anthera Pharmaceuticals Completes Interim B-Cell Analysis of PEARL-SC Study

HAYWARD, Calif., Dec. 1, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.

After analysis by an independent statistician, data from the on-going PEARL-SC study indicate 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.

Anthera Pharmaceuticals, Inc. (ANTH) Announces Last Patient Enrolled in PEARL-SC Study

HAYWARD, Calif., Oct. 25, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has completed enrollment in the Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus (SLE). The targeted number of five hundred and forty (540) patients has been randomized in 11 countries and 72 clinical sites worldwide.

Anthera Pharmaceuticals announces pricing of $31.5 million PIPE financing

 

HAYWARD, Calif., Sept 21, 2010 /PRNewswire via COMTEX News Network/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), today announced that it has entered into definitive agreements with certain accredited investors in connection with a private placement, or PIPE, financing transaction pursuant to Section 4(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder. Upon the closing of the transaction, Anthera will receive gross proceeds of approximately $31.5 million in exchange for the issuance to such investors of 10,500,000 units, with each unit consisting of one share of Anthera common stock and one warrant to purchase 0.40 shares of Anthera common stock. The warrants will be exercisable for a period of five years from the date of their issuance at an exercise price of $3.30 per share. The closing of the transaction, which is subject to customary closing conditions, is scheduled to occur on or prior to September 24, 2010. Anthera intends to use the net proceeds of the transaction to fund the previously announced expansion of Anthera’s A-623 Phase 2b study, known as PEARL-SC (A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A-623 AdministRation in Subjects with Systemic Lupus Erythematosus), the manufacture of Phase 3 material for A-623, and for general corporate purposes.

Anthera Pharmaceuticals completes initial public offering

 

HAYWARD, Calif., March 4, 2010 /PRNewswire via COMTEX News Network/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced the completion of its initial public offering of six million shares of common stock at a price of $7.00 per share. The net proceeds of the offering to Anthera, after deducting underwriting discounts and commissions and estimated offering expenses payable by Anthera, were approximately $36.7 million. In addition, Anthera has granted the underwriters a 30-day option to purchase up to an additional 900,000 shares to cover over-allotments, if any. The sole book-running manager of the offering is Deutsche Bank Securities Inc. Piper Jaffray & Co. is a co-lead manager of the offering and Cowen and Company, LLC and Merriman Curhan Ford & Co. are co-managers of the offering.

Anthera’s varespladib meets primary endpoint in phase 2 FRANCIS trial for the treatment of Acute Coronary Syndrome

 
– Favorable results for secondary endpoints support outcomes benefit

HAYWARD, CA – May 6, 2009 – Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression), a clinical trial designed to examine the impact of 500mg of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event, met its primary endpoint of a reduction in Low Density Lipoprotein Cholesterol (LDL-C). All patients in the FRANCIS trial received once daily doses of 80mg of Lipitor® (atorvastatin calcium), plus 500mg of varespladib or matching placebo. Varespladib is a potent and highly selective oral inhibitor of secretory phospholipase A2 (sPLA2), an inflammatory enzyme implicated in ACS, vascular inflammation, atherosclerosis and adverse lipid profiles.