Liprotamase

HAYWARD, Calif., Feb. 05, 2018 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals (Nasdaq:ANTH) is pleased to announce that the final patient has completed the last visit in the primary treatment phase of RESULT, a Phase 3 clinical study of Sollpura for exocrine pancreatic insufficiency (“EPI”) due to cystic fibrosis. Although the data remains blinded, two successful interim futility analyses were conducted by the independent Data Monitoring Committee which is comprised of experts appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network. During these reviews, no safety concerns were reported, and it was recommended that the study continue as planned. Top line data will be available later this quarter. "We are just weeks away from top line data now that the final patient has completed the last treatment visit in the RESULT study,” remarked Craig Thompson, President and Chief Executive Officer at Anthera Pharmaceuticals. “Sollpura is one step closer to potentially providing the first oral, non-porcine pancreatic enzyme replacement therapy (PERT). We look forward to sharing the top line data once available." “Data from the previous SOLUTION study and the solubility characteristics of Sollpura suggest that the higher dosing employed in the RESULT study will achieve non-inferiority to porcine PERTs,” shared Dr. Michael W. Konstan, deputy dean of the Case Western Reserve University School of Medicine in Cleveland. “The availability of an oral, non-porcine, alternative source for pancreatic enzyme replacement remains an important goal, and we look forward to the upcoming data." The RESULT study enrolled 140 patients ages 7 to 58 years. Prior to randomization, the majority of patients were on Creon and 42% of patients were on gastric acid suppressants. Based on the outcome of the RESULT study, Sollpura has the potential to become the first oral, non-porcine PERT which may provide a reduction in the size and number of pills for patients with EPI. 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 B-cell associated renal diseases. Additional information on the Company can be found at . 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 September 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, 305-567-0821 frannie.marmorstein@rbbcommunications.com Source: Anthera Pharmaceuticals, Inc.

Completed Interim Analysis from Phase 3 Trial with Blisibimod for Systematic Lupus Erythematosus Completed Interim Analysis from Phase 2/3 Trial with Blisibimod for IgA Nephropathy Increased Cash Position by $43 Million Through Equity Investment by Zenyaku and Equity Offering Received $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Phase 3 Development of Sollpura (liprotamase) HAYWARD, Calif., May 11, 2015 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced financial results and an operational update for the first quarter ended March 31, 2015. Net loss for the quarter ended March 31, 2015 was $7.7 million, compared to $7.9 million for the same period in 2014. Research and development expense for the quarter ended March 31, 2015 was $6.0 million, compared to $5.8 million for the same period in 2014. The increase in research and development expense was primarily due to expansion activities for our BRIGHT-SC IgA nephropathy study and manufacturing activities for our upcoming Phase 3 SOLUTION study with liprotamase. General and administrative expense for the quarter ended March 31, 2015 was $1.9 million, compared to $1.8 million for the same period in 2014. Non-operating expense for the quarter ended March 31, 2015 was reduced from $0.3 million to $3,000 mainly as a result of a reduction in interest expense driven by our elimination of all debt financing arrangements in the fourth quarter of 2014. As of March 31, 2015, we had cash and cash equivalents of $41.6 million, compared to $2.6 million as of December 31, 2014. The increase in our cash balance was mainly driven by total financing proceeds of $45.5 million received from the sale of our common stock through a public offering for $26.9 million, $11.6 million from the sale of common stock through an at-the-market offering and $7.0 million from an equity investment by our collaborative partner, Zenyaku, in the first quarter of 2015. First Quarter Operational Update: Sollpura™ ( liprotamase) Manufacturing activities for liprotamase progressed on schedule with respect to both capsule and sachet products. Sachet formulation development was substantially completed and pilot-scale feasibility was executed demonstrating manufacturability. In March 2015, we received a research award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of our novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase). Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation which supports and governs activities related to cystic fibrosis drug discovery through the many stages of drug development and clinical evaluation. Blisibimod – Systemic Lupus Erythematosus In February 2015, we modified the primary efficacy endpoint of CHABLIS-SC1 from the SRI-8 responder index to SRI-6 (previously a secondary endpoint of the study). The SRI (SLE Responder Index) is a recognized endpoint by the FDA for previously approved therapeutics. The change in primary efficacy endpoint was based on our Scientific Advisory Board's evaluation of published clinical data from other recent lupus studies with BAFF inhibitors in which the outcomes as measured using SRI-6 endpoint were more consistent. Subsequent to the amendment of the primary endpoint, an independent un-blinded statistician conducted an interim analysis of CHABLIS-SC1 based on the proportion of responders to the SRI-6 at a pre-specified time point. Based on this analysis, the un-blinded statistician recommended the study to continue to completion as planned. We anticipate full enrollment of 400 patients in the CHABLIS-SC1 trial to be completed this year with top-line efficacy data expected in the second half of 2016. Blisibimod – IgA Nephropathy In March 2015, an interim analysis of the BRIGHT-SC study was conducted by an independent un-blinded statistician, who evaluated several important biomarkers of renal disease in IgA nephropathy amongst patients who had completed at least 8 weeks of treatment. Based on the results of the interim analysis, it was recommended that the BRIGHT-SC trial should continue to completion. Following this outcome, in collaboration with our partner Zenyaku, we are expanding the number of BRIGHT-SC worldwide clinical sites. About Anthera Pharmaceuticals Anthera Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. Our first Phase 3 product candidate, 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 systemic lupus erythematosus, or lupus, and Immunoglobulin A nephropathy, an orphan disease with no approved treatment to address its root cause. Our second Phase 3 product candidate, liprotamase, is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy ("PERT") intended for the treatment of patients with Exocrine Pancreatic Insufficiency ("EPI"), often seen in patients with cystic fibrosis and other conditions. We are working with the Cystic Fibrosis Foundation in hopes of delivering a new option to patients left behind by currently available therapies. 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, 2014. 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. ANTHERA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, 2015 2014 Revenues: License fee $ 49 $ — Sponsored research and development 196 — Total revenues 245 — Operating Expenses: Research and development $ 5,995 $ 5,765 General and administrative 1,907 1,844 Total operating expenses 7,902 7,609 Loss from operations (7,657) (7,609) Other Expenses: Interest expense — (259) Other expense (3) (48) Total other expenses (3) (307) Net loss $ (7,660) $ (7,916) Net loss per share attributable to common stockholders: Basic and diluted $ (0.28) $ (0.39) Weighted-average number of shares used in per share calculation: 27,595,081 20,132,252 Basic and diluted ANTHERA PHARMACEUTICALS, INC. BALANCE SHEET DATA (in thousands, except share data) (unaudited) March 31, 2015 December 31, 2014 Cash and cash equivalents $ 41,648 $ 2,639 Accounts receivable $ 650 $ — Total assets $ 43,569 $ 3,490 Total deferred revenue $ 2,051 $ — Total liabilities, excludes deferred revenue $ 6,406 $ 5,751 Accumulated deficit $ (324,471) $ (316,811) Total shareholders' equity (deficit) $ 35,112 $ (2,261) Common shares outstanding 35,816,364 23,005,209 CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc. dlutz@anthera.com or 510.856.5598 Help employers find you! Check out all the jobs and post your resume.