Where Does Anthera Go From Here?

Given the current share price for Anthera Pharmaceuticals Inc ANTH, H.C. Wainwright’s Andrew S. Fein believes the market appears to have “written off both the lupus and the CF programs.”

Fein maintains a Buy rating on the company, while lowering the price target from $10 to $3.

Disappointing Top-Line Results

“While we had always advised investors to view the lupus program as value optionality, we continue to believe that liprotamase (Sollpura) likely works as pancrease replacement therapy,” the analyst mentioned.

However, following the top-line results announced by Anthera Pharmaceuticals on December 28, Fein believes it would be difficult to demonstrate Sollpura’s benefit in a trial setting.

Since management does intend to move ahead with an improved study, the analyst pointed out that the company would need to address two main issues in 2017.

The Way Forward

Firstly, while the SOLUTION study had been effectively designed by the FDA, “at this stage it would be very risky to move ahead with a new protocol towards a BLA without taking in thorough FDA input first.”

Secondly, the top-line data suggests liprotamase’s tolerability in the SOLUTION study was slightly worse than that of comparator pancrease.

Management explained, however, that this tolerability profile was for the Sollpura patients who had been underdosed for efficacy.

“This profile raises the question of whether a new non-inferiority protocol is the optimal choice,” Fein noted.

The analyst believes additional clarity regarding the clinical and regulatory path could itself prove to be a catalyst for the stock in early 2017.

In Thursday's pre-market session, shares of Anthera were down 2.96 percent at $0.720.