Hayward, Calif.-based Anthera Pharmaceuticals, Inc. (ANTH) announced today that its Japanese development partner, Zenyaku, had ended a December 2014 Collaboration and License Agreement. The deal will terminate Jan. 7, 2016.

The original deal was for the development of blisibimod in Japan. Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine. It was originally developed to treat lupus and IgA nephropathy. BAFF is vital to the development, maintenance and survival of B-cells, a type of immune cell. The drug appears to inhibit BAFF, which in turn seems to regulate B-cell activity, which is involved in certain types of autoimmune disorders.

“Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing,” said Paul Truex, president and chief executive officer of Anthera in a statement. “Zenyaku’s termination of the License Agreement will provide flexibility for us to pursue a potentially optimized development path for blisibimod in IgA nephropathy and facilitate discussions with alternative partners in Asia at the appropriate time. As a result of our financing efforts over the past twelve months, including Zenyaku’s substantial equity investments and cost reimbursements, we remain well funded to advance the development of blisibimod and Sollpura.”

In the original deal, Anthera kept full development and commercialization rights for global territories including North America and the European Union, outside Asia. As part of that deal, Zenyaku was to pay up to $26 million over an 18-month period through a combination of a forgivable loan and multiple equity purchases of Anthera common stock priced to a 33 percent premium over the volume weighted average stock price at the time. Zenyaku was also to reimburse Anthera for some of the clinical trial expenses. An additional $22 million was to be paid out for various milestones.

Amgen (AMGN) originally developed blisibimod. As part of that deal, Amgen was also eligible for some milestone payments in the Asian markets if the drug was commercialized.

At Anthera’s 2015 second quarter financial reporting in August, the company reported a net loss for the quarter of $8.9 million and for the six-month period, $16.6 million, improvements over the same periods in 2014.

The company reported that its drug, Sollpura (liprotamase), for cystic fibrosis patients who suffer from exocrine pancreatic insufficiency, was about to start a Phase III clinical trial. It has also started planning another clinical study with a powder formulation of the drug in infants and toddlers.

The company also received a $1.1 million research award in June 2015 from the Cystic Fibrosis Foundation Therapeutics, Inc.

Anthera is also currently enrolling patients in the Phase III CHABLIS-SC1 clinical study of blisibimod for systemic lupus erythematosis (SLE). The funding in part comes from a July public offering.

Anthera stock is rather volatile at the moment. Shares traded on June 19 for $9.21, dropped on July 9 to $7.47, rose on July 27 to $11.15. Shares dropped again to $7.01 on Aug. 25, rose to $8.18 on Sept. 10 and are currently trading for $7.63.

“Regaining full worldwide control of blisibimod development, and in particular the IgA nephropathy program, is exciting as we are now free to consider additional approaches including the potential examination of the clinical data from the BRIGHT-SC study at an earlier time point than originally planned,” said Colin Hislop, Anthera’s chief medical officer in a statement. “The BRIGHT-SC study remains fully blinded and will continue as planned with all currently enrolled patients continuing to follow the protocol.”

September 15, 2015
By Mark Terry, BioSpace.com Breaking News Staff

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