Date: 2015-09-14
Type of information: Termination of an agreement
Compound: blisibimod
Company: Anthera Pharmaceuticals (USA - CA) Zenyaku Kogyo
Therapeutic area: Autoimmune diseases - Renal diseases
Type agreement: licensing
Action mechanism: Blisibimod is a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod is a novel FC-fusion protein, or peptibody, and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. BAFF, also known as BLyS (B lymphocyte stimulator), is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. B-cells represent a critical component of human immune response to infection and other pathogens. However, abnormal elevations of B-cells and BAFF may lead to an overactive immune response which may damage normal healthy tissues and organ systems.
Disease: lupus, IgA nephropathy
Details: * On December 15, 2014, Anthera Pharmaceuticals announced that Anthera and Zenyaku Kogyo executed an exclusive license agreement for the development and commercialization of subcutaneous blisibimod in Japan and potentially other countries throughout Asia . Anthera retains full development and commercialization rights for all other global territories including North America and the European Union . Zenyaku currently markets Rituxan™, an anti-CD20 antibody, in Japan where it is approved for CD20 Positive B-Cell Lymphoma, B-cell Lymphoproliferative disorder, ANCA associated vasculitis (GPA, MPA), and Pediatric Nephrotic Syndrome. "Our partnership with Zenyaku brings together two highly complementary organizations with extensive experience in the development of therapeutics for immunology and oncology. Zenyaku's long history and experience with Rituxan in renal diseases, including the recent approval of Rituxan in Japan for relapsing steroid-dependent nephrotic syndrome, will be invaluable as we continue to advance blisibimod globally for the treatment of IgA Nephropathy," said Paul F. Truex , Anthera's President and Chief Executive Officer. "Zenyaku's previous efforts in Lupus Nephritis will provide helpful insights as we explore the best patient options for the use of blisibimod in Systemic Lupus Erythematosus." * On October 1, 2014, Anthera Pharmaceuticals confirmed it is engaged in potential partnership negotiations for blisibimod for both lupus and IgA nephropathy in territories outside the United States. Anthera does not intend to communicate further regarding these discussions unless and until a definitive agreement is executed. There can be no assurance that such a definitive agreement will be executed relating to any proposed partnership, or that any partnership will be approved or consummated.
Financial terms: In exchange for the licensed rights, Zenyaku will provide up to $26 million over the next 18 months through a combination of a forgivable loan and multiple equity purchases of Anthera common stock at prices equal to a thirty-percent premium over the volume weighted average stock price for the twenty days preceeding the exercise of Anthera's option. Additionally, Zenyaku will reimburse Anthera for a portion of clinical trial expenses incurred as part of blisibimod's global development. Zenyaku will purchase all clinical supplies of blisibimod from Anthera. Anthera is eligible to receive an additional $22 million in future development and sales milestones, as well as incremental gross margin associated with eventual commercial supply of blisibimod in the Zenyaku territory. In parallel with the Zenyaku partnership, Amgen, the originator of blisibimod, and Anthera have agreed to modify certain milestone and royalty payments relating to Japan in exchange for shares of Anthera common stock. Funds from this partnership are expected to substantially reduce Anthera's cash expense associated with the development of blisibimod through 2018
Latest news: * On September 14, 2015, Anthera Pharmaceuticals announced receipt of a termination notice from its development partner in Japan , Zenyaku, terminating the December 2014 Collaboration and License Agreement effective January 7, 2016 . The termination was "at will" and alleged no breach of the License Agreement by Anthera. At the time of the notification, no patients had been enrolled in any blisibimod clinical studies in the Zenyaku territory and Zenyaku had not purchased any blisibimod product from Anthera. As previously disclosed, Anthera entered into a collaboration and license agreement with Zenyaku in December 2014 . The License Agreement required Zenyaku, subject to mutually agreed timelines, to develop and commercialize blisibimod in Japan. Prior to the notification of termination Zenyaku purchased $9.0 million of Anthera common stock at a thirty-percent premium to a trailing market price. Anthera Pharmaceuticals will regain full worldwide control of blisibimod development.
