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Anthera Pharmaceuticals Provides Business Update And Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

Closed $29 million public offering in July including full exercise of underwriters’ option to purchase additional shares

Completed capsule manufacturing in support of the SOLUTION clinical study

Initiated the SOLUTION clinical study of oral Sollpura™

To regain all Japan rights to blisibimod following termination of Asia partnership

HAYWARD, Calif., November 6, 2015 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a business update and reported financial results for the third quarter ended September 30, 2015.

Recent Developments and Business Highlight s:

Clinical Development

Sollpura™ (liprotamase)

Completed Manufacturing, Testing and Release of Sollpura™ Capsules

In August, we completed the manufacturing of Sollpura™ capsules in two dosage strengths, which enabled the initiation of our Phase 3 clinical study, SOLUTION and triggered the achievement of several milestones under a research award granted to us by Cystic Fibrosis Foundation Therapeutics, Inc. (“CFFT”). Consequently, we expect to receive research funding of approximately $1.4 million from CFFT in the fourth quarter.

Initiated Phase 3 Clinical Study

In September, we initiated the SOLUTION Phase 3 clinical study evaluating the

efficacy and safety of Sollpura™

in patients with cystic fibrosis who suffer from exocrine pancreatic insufficiency. The SOLUTION study is expected to enroll approximately 130 patients across more than 50 clinical sites around the United States and Europe.

For more information on the SOLUTION clinical study, please visit

https://clinicaltrials.gov/ct2/show/NCT02279498

Pediatric Clinical Study is Under Development

We began planning for a second clinical study, SIMPLICITY, to support pediatric use. The SIMPLICITY clinical study will use a powder for solution formulation of Sollpura™ that is packaged in sachets for ease of administration. SIMPLICITY is currently planned for initiation in late 2015 or early 2016. Manufacturing activities to support the SIMPLICITY study, including finalizing the new sachet formulation are complete. Planning for the manufacture of two dosage strengths of Sollpura™ Powder for Oral Solution sachets are in progress. Feedback from the European Medicines Agency and U.S. FDA on the company’s pediatric plan was received. The SIMPLICITY clinical study design is being modified to incorporate the agencies’ suggestions. SIMPLICITY will be the first clinical study to study the use of a powder for solution formulation in an easy to administer packet.

Blisibimod -

Systemic Lupus Erythematosus (“SLE”)

Phase 3 CHABLIS-SC1 Clinical Study Enrollment Completed

We closed enrollment for this study in July after we surpassed the enrollment target of 400 patients. Topline efficacy and safety data from the study is expected in the second half of 2016.

Phase 3 CHABLIS 7.5 is Approaching Initiation

Planning for our second Phase 3 lupus study, CHABLIS 7.5 study is well underway. The CHABLIS 7.5 study will evaluate the efficacy and safety of blisibimod...


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