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Anthera Pharmaceuticals, Inc. (ANTH) Posts Q1 Loss of 39c/Share

May 13, 2014 8:39 AM

Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) reported Q1 EPS of ($0.39), $0.07 better than the analyst estimate of ($0.46).

First Quarter Operational Update:

Clinical

Blisibimod for the treatment of Systemic Lupus Erythematosus (CHABLIS-SC1)

Our Phase 3 lupus clinical study, CHABLIS-SC1, is recruiting at 51 sites across 11 countries in Eastern Europe, Latin America and Southeast Asia. In March an independent Data Safety Monitoring Board ("DSMB") recommended continuing the CHABLIS-SC1 clinical study following a scheduled interim data and safety review. To date, enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study are consistent with our goal to enroll patients with higher levels of lupus activity and positive biomarkers despite the stable use of corticosteroids. These characteristics were predictive of improved outcomes in our previous Phase 2 clinical study. A scheduled interim analysis of efficacy for the CHABLIS-SC1 study will be conducted by an independent un-blinded statistician after a minimum of 100 subjects have completed 24 weeks of treatment to confirm the clinical and commercial assumptions of the study. Additional information and publications from the CHABLIS-SC1 clinical study can be found at http://www.anthera.com/studies_chablis-sc1.htm.

In the first quarter of 2014, we submitted the final protocol to the US FDA for our second lupus registration study, CHABLIS-SC2. This second study is expected to enroll up to 400 patients with active lupus, including patients with glomerulonephritis who may have a previous diagnosis of Lupus Nephritis. Consistent with the CHABLIS-SC1 clinical study, the primary endpoint of this second study will be the SRI-8 response. These two pivotal studies will form the basis of a submission for blisibimod as a treatment for patients with active lupus.

Recently, we published data from our phase 2 PEARL-SC study in the Annals of Rheumatic Diseases. Data from the PEARL-SC study indicated that baseline disease severity and choice of endpoints are critical to evaluating the benefit of the medication.. A link to the online publication can be accessed at http://ard.bmj.com/cgi/content/full/annrheumdis-2013-205144?ijkey=BpDOTvHrIYFoz1r&keytype=ref.

Additionally, a review article entitled "The Potential Role of Blisibimod for the Treatment of Systemic Lupus Erythematosus", was published in the International Journal of Clinical Rheumatology. The article provided a developmental summary of blisibimod, as well as the structural differentiation of blisibimod as compared to other anti-BAFF antibodies such as belimumab and tabalumab. A link to the online publication can be accessed at http://www.futuremedicine.com/doi/abs/10.2217/ijr.14.7.

Data from PEARL-SC will be presented in two posters in June 12, 2014 at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Paris, France. Two abstracts will summarize findings from the Open-Label Extension study pertaining to the durability of effects of blisibimod over 52 weeks on renal biomarkers, including proteinuria.

Poster: "Effects of Chronic Treatment with Subcutaneous blisibimod on Renal and Inflammation Biomarkers in Subjects with Systemic Lupus Erythematous in Phase 2 PEARL-SC and Open-Label Extension Studies"

Poster: "Effects of Blisibimod on Serum Immunoglobulins and Infection Risk in Patients with Systemic Lupus Erythematosus from the Placebo-controlled PEARL-SC and Open-Label Extension Studies"

Blisibimod for the treatment of IgA Nephropathy (BRIGHT-SC)

The BRIGHT-SC clinical study is currently recruiting IgA nephropathy patients in seven countries in Southeast Asia. The Company plans to conduct a interim analysis to determine the effect of blisibimod on proteinuria after eight weeks of treatment in the second half of 2014.

We believe blisibimod and the BRIGHT-SC clinical study represent the only therapeutic approach intended to specifically target the underlying biological problem of IgA nephropathy – immunoglobulin complex formation. Unlike potential anti-inflammatory treatments for IgA nephropathy – Blisibimod's specific targeting of B cells and plasma cells may safely reduce IgA and IgG production and inflammation and potentially halt further damage to the kidney – key to improving clinical outcomes.

To date, baseline characteristics of patients enrolled in the BRIGHT-SC study are consistent with our objectives to enroll patients with a biopsy diagnosis of IgA Nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease. Additional information and publications from the BRIGHT-SC clinical study can be found at http://www.anthera.com/studies_bright-sc.htm.

Blisibimod for the treatment of Refractory Multiple Myeloma

In the first quarter of 2014, building on data generated by Amgen, Inc., we initiated a preclinical study to evaluate the effect of blisibimod on multiple myeloma. The goal of the preclinical study is to examine the potential use of blisibimod for the treatment of multiple myeloma in combination with current therapies including the new class of proteasome inhibitors. Data from the preclinical study is expected to guide our Phase 2 clinical study to evaluate the effects of blisibimod on survival, progression and biomarkers in patients with relapsed or refractory multiple myeloma treated with at least one prior regimen.

For earnings history and earnings-related data on Anthera Pharmaceuticals, Inc. (ANTH) click here.

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