Anthera Pharma (ANTH) Posts Wider-than-Expected Q3 Loss

November 4, 2016 8:34 AM EDT
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Anthera Pharma (NASDAQ: ANTH) reported Q3 EPS of ($0.61), $0.23 worse than the analyst estimate of ($0.38).

Recent Developments and Business Highlights:

Blisibimod for the treatment of Systemic Lupus Erythematosus (“SLE”)

  • Topline Data from Phase 3 CHABLIS-SC1 Clinical Study We have been working diligently through the adjudication for the CHABLIS-SC-1 study, which completed the last patient visit in September. We currently plan to report topline efficacy and safety data prior to the 2016 American College of Rheumatology Annual Meeting taking place from November 11th to November 16th. Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study. For more information on the CHABLIS-SC1 study, please visit http://www.anthera.com/clinical-studies/chablis_sc/.
  • Phase 3 CHABLIS 7.5 Clinical Study Enrollment and Clinical Site Activation On Track We continued further clinical site activation for, and enrollment in CHABLIS 7.5, our second Phase 3 clinical study. This study will evaluate the efficacy and safety of blisibimod in patients who, despite corticosteroid use, continue to have clinically-active lupus (SLE) and the presence of anti-double-stranded DNA and low complements which are known serological markers of lupus. For more information about the CHABLIS 7.5 study, visit http://www.anthera.com/clinical-studies/chablis_7-5/.

Sollpura™ (liprotamase) for the treatment of Exocrine Pancreatic Insufficiency (“EPI”)

  • Phase 3 SOLUTION Clinical StudyFollowing the completion of patient enrollment in our Phase 3 SOLUTION study, an independent Data and Safety Monitoring Board (DSMB) recommended continuation of the study without modification on August 3, 2016. Subsequent assessment by the DSMB on September 25, 2016, found no concerning safety signals. We expect to report topline efficacy data from the SOLUTION study before the end of 2016. For more information on the SOLUTION clinical study, please visit http://www.anthera.com/clinical-studies/solution_study/.
  • SIMPLICITY Clinical Study Enrollment on Track Enrollment in the SIMPLICITY study, which intends to evaluate the efficacy and safety of Sollpura™ supplied as a powder for oral solution, is on track. In this study, Sollpura™ is delivered in a convenient, easy-to-administer single use package. We completed enrollment of the initial cohort of patients 7 years of age and above, and following a review of safety and efficacy data by an independent DSMB, the study will allow for administration of Sollpura™ powder for oral solution to pediatric patients ranging in age from 28 days to less than 7 years. For more information on the study, please visit http://www.anthera.com/clinical-studies/simplicity-study/.
  • EASY Clinical StudyDuring the third quarter of 2016, we initiated the EASY study, which provides continued access to Sollpura™ for patients who completed the SOLUTION study. We plan to continue the EASY study until Biologic License Application (“BLA”) for Sollpura™ is approved by the U.S. Food and Drug Administration (“FDA”).
  • Manufacturing to Support Commercial Readiness Accelerated We began acceleration of the manufacturing scale-up to support the commercial launch of Sollpura™ including the completion of demonstration and registration batches at commercial launch scale. We had a Type-C meeting with the FDA in September to discuss the manufacturing approach for the Lipase-CLEC drug substance and the conversion of the filed Sollpura™ New Drug Application (“NDA”) to a BLA. The FDA confirmed that Sollpura™ fits the regulatory definition of a biologic, supporting the conversion of the filed NDA to a BLA. Furthermore, preliminary agreement was reached on Anthera’s approach to demonstration of comparability of drug substance manufactured by a new contract manufacturing organization (“CMO”), and the potential use of a comparability protocol to manage post-approval process scale up.

Blisibimod for the treatment of IgA Nephropathy

  • Longer-Term Evaluation Continues in Phase 2 BRIGHT-SC Clinical StudyIn June 2016, an interim analysis of observed data from 57 patients, all of whom had the opportunity to complete 24 weeks of treatment, demonstrated a positive trend in lower proteinuria in blisibimod versus placebo treated patients over two years, supporting continuation of the study. Data from the 48-week evaluation is expected at the end of this year or in early first quarter of 2017. For more information about the BRIGHT-SC study, visit http://www.anthera.com/clinical-studies/bright-sc/.

For earnings history and earnings-related data on Anthera Pharma (ANTH) click here.



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