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Anthera (ANTH) Stock Falls on Poor Phase III Sollpura Data

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Anthera Pharmaceuticals, Inc.ANTH announced disappointing top-line data from a phase III study - SOLUTION - on one of its pipeline candidates, Sollpura (liprotamase), in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). Shares of the company plunged 58.2% on Dec 27, during the after-hours trading session. Moreover, the company's shares were down 57.8% on Dec 28, during the pre-market trading session.

Anthera's year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, Anthera has tumbled 57.6% during this period, while the industry lost 24.5%.

The study was conducted to evaluate non-inferiority of Sollpura in comparison to Johnson & Johnson Janssen Pharmaceuticals, Inc.'s porcine-derived, enterically coated pancreatic enzyme replacement therapy, Pancreaze, when administered to patients with EPI due to cystic fibrosis.

The study was conducted to evaluate non-inferiority of Sollpura in comparison to Johnson & Johnson JNJ Janssen Pharmaceuticals, Inc.'s porcine-derived, enterically coated pancreatic enzyme replacement therapy, Pancreaze, when administered to patients with EPI due to cystic fibrosis.

According to information provided by Anthera in its press release, the study barely missed the primary endpoint of a change in the Coefficient of Fat Absorption (CFA) non-inferiority margin. However, Sollpura achieved the statistical criterion for nitrogen absorption. On the safety front, Sollpura was found to be well tolerated in comparison to Pancreaze, though symptoms associated with malabsorption were modestly more recurrent in the Sollpura arm.

Considering the robust activity demonstrated by Sollpura in the study, the company believes that the deficiency in fat absorption may be addressed by small changes in study design, including more liberal dose adjustment. Therefore, Anthera plans to initiate an additional study on Sollpura in patients with EPI due to cystic fibrosis.

The study is expected to begin in the first quarter of 2017. The company further noted that alterations in the study will help patients achieve optimal level of fat absorption as measured by CFA and provide necessary flexibility to adjust Sollpura dose, based on malabsorption symptoms at any time during the study.

Anthera anticipates a slight delay in the filing of a regulatory application in the U.S. to around the first quarter of 2018, as the new study, and the required chemistry, manufacturing, and control activities will complete simultaneously.

Anthera also anticipates reporting data from the extension phase of the SOLUTION study in the first quarter of 2017. The company further intends to continue the SIMPLICITY study in younger pediatric patients and the open-label EASY study.

The recent development is concerning given that company doesn't have any approved product in its portfolio. We note that the latest pipeline setback comes over a month after the company announced the failure of another phase III study, CHABLIS-SC1, on blisibimod for the treatment of systemic lupus erythematosus, to meet the primary endpoint.

ANTHERA PHARMA Price and Consensus

ANTHERA PHARMA Price and Consensus | ANTHERA PHARMA Quote

Zacks Rank & Key Picks

Anthera carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in this industry include Arbutus Biopharma Corporation ABUS and MannKind Corporation MNKD . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Arbutus' loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.52 for 2017 over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.

MannKind's estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, its loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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