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 Licenses Japan Rights for Blisibimod to Zenyaku Kogyo Co., Ltd.

 
Anthera Pharmaceuticals Licenses Japan Rights for Blisibimod to Zenyaku Kogyo Co., Ltd.

– Anthera to receive up to $48,000,000 plus future product margin on commercial supply
– Zenyaku to reimburse Anthera for a portion of future blisibimod worldwide development costs
– Zenyaku to assume full responsibility for development and associated costs in Japan and potentially other Asian territories in the future
– Companies will collaborate on blisibimod development for both IgA Nephropathy (“IgAN”) and Systemic Lupus Erythematosus (“Lupus”)

HAYWARD, Calif., Dec. 15, 2014 /PRNewswire/ –– Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced today that Anthera and Zenyaku Kogyo Co., Ltd. of Tokyo, Japan executed an exclusive license agreement for the development and commercialization of subcutaneous blisibimod in Japan and potentially other countries throughout Asia. Anthera retains full development and commercialization rights for all other global territories including North America and the European Union. Zenyaku currently markets Rituxan™, an anti-CD20 antibody, in Japan where it is approved for CD20 Positive B-Cell Lymphoma, B-cell Lymphoproliferative disorder, ANCA associated vasculitis (GPA, MPA), and Pediatric Nephrotic Syndrome.

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.

Milestone Pharmaceuticals Appoints Paul Truex to the Board of Directors

 

MONTREAL, March 5, 2012 (GLOBE NEWSWIRE) Milestone Pharmaceuticals Inc., a cardiovascular drug development company, today announced the appointment of Paul F. Truex to its Board of Directors. Mr. Truex is Chief Executive Officer, Founder and a Director of Anthera Pharmaceuticals Inc. (Nasdaq:ANTH), a biopharmaceutical company focused on developing drugs to treat serious illnesses, including cardiovascular and autoimmune diseases.

Milestone Pharmaceuticals Appoints Paul Truex to the Board of Directors

MONTREAL, March 5, 2012 (GLOBE NEWSWIRE) Milestone Pharmaceuticals Inc., a cardiovascular drug development company, today announced the appointment of Paul F. Truex to its Board of Directors. Mr. Truex is Chief Executive Officer, Founder and a Director of Anthera Pharmaceuticals Inc. (Nasdaq:ANTH), a biopharmaceutical company focused on developing drugs to treat serious illnesses, including cardiovascular and autoimmune diseases.

“Mr. Truex brings relevant operating, deal-making and financing experience to Milestone’s Board,” commented Philippe Douville, Chief Executive Officer of Milestone. “He exhibits a high level of passion to the business of drug development, and we look forward to benefiting from his guidance as Milestone pursues its strategy in preparing for its first clinical studies.”

Mr. Truex was responsible for the initial acquisition of Anthera’s intellectual property from negotiations with pharmaceutical companies. Prior to founding Anthera Pharmaceuticals, Mr. Truex served as a Founder, Director, President and CEO of Peninsula Pharmaceuticals. During that time, Mr. Truex raised over $81 million of institutional investment and strategic partner capital. Peninsula was acquired by Johnson and Johnson in April of 2005 for $245 million in an all cash transaction. Over the span of his career, Mr. Truex has successfully raised over $150 million in venture investments and more than $200 million in various public equity and debt offerings, including Anthera’s Initial Public Offering in 2010. Prior to Peninsula, he served as a Senior Executive of Versicor (acquired by Pfizer) and participated in the company’s successful $55 million initial public offering in 2000. Before joining Versicor, Mr. Truex worked at Eli Lilly and Company where he served in various marketing and sales roles during the launch of three different products for the primary care physician market (Actos’ Evista’ and Humalog 75/25).

Mr. Truex obtained his Masters of Business Administration in Marketing and Finance from Indiana University and a Bachelor of Arts degree in Economics from the University of Waterloo. Mr. Truex is a member of the Board of Directors of Trius Therapeutics, Eiger Biopharmaceuticals and Waterloo Pharmaceuticals, Inc.

Mr. Truex will replace Mr. Cedric Bisson who has retired from Milestone’s Board of Directors. The members of Milestone’s Board are grateful to Mr. Bisson for his unique and outstanding contribution to the development of the company over the past six years and wish him much success in his future endeavors.

About Milestone Pharmaceuticals

Milestone is a drug development company developing novel small molecule therapeutics based on clinically validated mechanisms for cardiovascular diseases. Milestone’s lead product is a novel and potent short-acting calcium channel antagonist for the systemic treatment of transient cardiovascular conditions such as atrial arrhythmias and angina. The Company has assembled a world-class scientific advisory board of key opinion leaders with significant cardiovascular expertise in cardiology, regulatory affairs, and drug development. Milestone was founded in 2005 and initially financed by iNovia Capital, Fonds BioInnovation and an angel investor. For more information, please visit www.milestonepharma.com

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 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.

“We believe reductions of B-cells in the PEARL-SC study will correlate to a reduction in disease activity in patients treated with blisibimod,” said Colin Hislop, MD, Chief Medical Officer and Senior Vice President of Anthera Pharmaceuticals. “This analysis demonstrates that the selected weekly and monthly blisibimod doses resulted in an appropriate biological response.  If confirmed with positive clinical outcomes from the PEARL-SC study, these data will provide guidance for the design of our phase 3 clinical studies and allow us to differentiate blisibimod from other available BAFF inhibitors for the treatment of lupus.”

Final results from the PEARL-SC clinical study are expected in the second quarter of 2012.  A proposed amendment to PEARL-SC also includes an option for an interim efficacy analysis to be conducted by an independent statistician after the 350th enrolled subject has reached 24 weeks in the study — the primary efficacy time point.

About PEARL-SC
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 clinical study enrolled five hundred and forty-seven (547) patients in 11 countries and 72 clinical sites worldwide.  The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in a SLE responder index — 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, with no new BILAG A or two new BILAG B organ domain flares.

*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 B-Cell Activating Factor (BAFF) and blisibimod
BAFF has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren’s Syndrome, Graves’ Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF’s potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.

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.