Zenyaku Ends Japan Alliance With Anthera
This article was originally published in PharmAsia News
Executive Summary
Anthera's development partner in Japan for autoimmune disorder drug blisibimod has served a termination notice for the late 2014 deal, but the US firm says the impact could in fact be positive.
US firm Anthera Pharmaceuticals Inc. is to regain all global rights at no cost to its experimental drug for lupus and other autoimmune disorders blisibimod (A-623), following the termination of a December 2014 alliance by Japanese partner Zenyaku Kogyo Co. Ltd.
The "at will" cancellation, effective Jan.7, 2016, means that Hayward, California-based Anthera is not the subject of any claim of breach of agreement. The precise reasons for privately held Zenyaku's decision are unclear at this stage, and no one at the firm's Tokyo headquarters was immediately available for comment. [See Deal]
Anthera executives actually appeared upbeat about the step, with president and CEO Paul Truex noting bluntly in a statement that "Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing."
The termination will in fact "provide flexibility for us to pursue a potentially optimized development path" in the indication and also would "facilitate discussions with alternative partners in Asia at the appropriate time," he added.
Under the late 2014 deal, Zenyaku received exclusive development and commercialization rights in Japan, and an option for rights in a range of additional Asian markets, to a subcutaneous formulation of blisibimod for immunoglobulin A (IgA) nephropathy and systemic lupus erythematosus.
Financing Details
Zenyaku was to provide a total of up to $26m over the first 18 months plus up to $22m in milestones, and an incremental gross margin on eventual commercial supplies of the product.
It made an initial $7m equity investment at a premium in Anthera and the agreement provided for the purchase of up to an additional $12m shares. Zenyaku had purchased a total of $9m in stock at a 33% premium to a trailing market price up to the cancellation, Anthera noted.
Other aspects of the deal included the Japanese firm extending a $7m loan forgivable on the achievement of certain development milestones, and the reimbursement of certain Anthera clinical development costs.
In all, the Zenyaku alliance was expected to substantially reduce Anthera's cash expenses for blisibimod development through to 2018.
However, the US firm stressed that its partner would continue to provide various funding during the termination period, and that recent fundraising had also given it a stronger financial foundation.
"As a result of our financing efforts over the past 12 months, including Zenyaku's substantial equity investments and cost reimbursements, we remain well funded to advance the development of blisibimod," Truex said.
Anthera raised around $28.8m gross in a public stock offering completed in July.
Clinical Plans
Blisibimod is a peptibody against B-cell activating factor (BAFF) comprising a BAFF binding domain fused to the N-terminus of the human antibody Fc region. BAFF, a cytokine member of the TNF ligand family, is involved in a variety of B-cell survival, development and maintenance pathways.
Anthera originally acquired global rights from originator Amgen in 2008, and the Zenyaku deal had triggered modifications to Anthera/Amgen's Japan milestones and royalty arrangements in exchange for Anthera shares.
Perhaps reflecting one of the possible reasons for the collapse of the Zenyaku alliance, Anthera noted that no patient enrollment in any trials planned by Zenyaku had begun and no product purchases made.
Anthera's ongoing programs in both lupus and the international BRIGHT-SC study for IgA nephropathy will continue unaffected. In fact the termination may now open the way to an earlier than planned examination of data from the still fully-blinded, placebo-controlled BRIGHT-SC program, Anthera's chief medical officer Dr, Colin Hislop added.
The 200-patient Phase II/III trial is assessing reduction in proteinuria after an eight-week induction of blisibimod 100mg three times a week and then 200mg weekly in a 16-week maintenance period in patients with initial proteinuria of 1-6g/24 hours.
Zenyaku has a diversified business including over-the-counter drugs and a small prescription portfolio that includes the co-marketed anti-CD20 antibody Rituxan (rituximab), launched in 2001 for B-cell non-Hodgkin's lymphoma and originally developed locally Chugai Pharmaceutical Co. Ltd. (Roche) and Biogen Idec.