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Press Release

Anthera Pharmaceuticals Announces Positive Outcome of Interim Futility Analysis in the Phase 3 RESULT Clinical Study of Sollpura


Posted on: 11 Dec 17

HAYWARD, Calif., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced a positive outcome of the pre-specified interim futility analysis for the RESULT Phase 3 clinical study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency (“EPI”).  The interim futility analysis was conducted by RESULT’s Data Monitoring Committee which is comprised of experts appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network.  Anthera completed patient recruitment in the RESULT study in November 2017, and based on the interim futility analysis, the study will proceed, as planned, with topline data expected in Q1 2018.

“The positive outcome of the interim futility analysis increases our confidence in the RESULT trial design, and marks the achievement of another major milestone in the clinical development of Sollpura,” shared Craig Thompson, President & Chief Executive Officer.  “We would like to thank the patients, study investigators, the US and European Cystic Fibrosis Foundations, and the cystic fibrosis community for the support they have provided as we bring this potential therapy to patients.”

The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study.  As with current practice with porcine pancreatic enzyme replacement therapies (“PERTs”), the RESULT study allows for dose titrations of Sollpura on an individualized basis to achieve maximum therapeutic benefit.  Sollpura has the potential to become the first non-porcine PERT, which may provide a reduction in the size and number of pills patients must consume daily due to the significantly more compact formulation of Sollpura than porcine PERTs.

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 Anthera 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 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 

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Source: Anthera Pharmaceuticals, Inc.

GlobeNewswire
globenewswire.com

Last updated on: 11/12/2017

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