Anthera Announces Termination of Blisibimod Partnership in Japan by Zenyaku
September 21 2015 - 8:46PM
- Anthera will regain all worldwide rights for blisibimod without
cost
- No patients were enrolled in the BRIGHT-SC study or any other
clinical study in Japan
- Zenyaku is required to continue various funding obligations
during the termination period
- No effect on blisibimod lupus program or Sollpura development
program
- BRIGHT-SC clinical study in patients with IgA Nephropathy will
continue
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced receipt
of a termination notice from its development partner in Japan,
Zenyaku, terminating the December 2014 Collaboration and License
Agreement (the "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.
"Progress of blisibimod in Japan, particularly for IgA
nephropathy, has been disappointing," said Paul F. Truex, Anthera's
President and Chief Executive Officer. "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."
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.
"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 Anthera's Chief
Medical officer, Dr. Colin Hislop. "The BRIGHT-SC study remains
fully blinded and will continue as planned with all currently
enrolled patients continuing to follow the protocol."
About Blisibimod
Blisibimod is a selective peptibody antagonist of the B-cell
activating factor (BAFF) cytokine that is initially being developed
as a treatment for lupus and IgA nephropathy. BAFF is a tumor
necrosis family member and is critical to the development,
maintenance and survival of B-cells. It is primarily expressed by
macrophages, monocytes and dendritic cells and interacts with three
different receptors on B-cells including BAFF receptor, or BAFF-R,
B-cell maturation, or BCMA, and transmembrane activator and
cyclophilin ligand interactor, or TACI. The BAFF-R receptor is
expressed primarily on peripheral B-cells. Blisibimod consists of a
novel BAFF binding domain fused to the N-terminus of the Fc region
of human antibody. Blisibimod binds to BAFF and inhibits the
interaction of BAFF with its receptors. The role of BAFF in lupus
has recently been clinically validated in multiple late-stage
clinical studies with anti-BAFF antibodies. We intend to advance
the development of our BAFF antagonist, blisibimod, to exploit its
broad potential clinical utility in autoimmune diseases, with
initial focus on lupus. Blisibimod demonstrates anti-BAFF activity
and has been shown to be safe and effective in selectively
modulating and reducing B-cells in Phase 1 and Phase 2 clinical
studies in lupus patients.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious and
life-threatening diseases, including lupus, lupus with
glomerulonephritis, IgA nephropathy, and exocrine pancreatic
insufficiency due to cystic fibrosis. Additional information on the
Company can be found at www.anthera.com.
About Zenyaku Kogyo
Zenyaku Kogyo is a privately-held Japanese pharmaceutical
company headquartered in Tokyo, Japan. The company is marketing in
Japan dermatological and anti-cancer drugs including Rituxan™, an
anti-CD20 antibody for the treatment B-cell Non-Hodgkin's Lymphoma.
The company also has an OTC consumer health care business including
Dickinin, a cold symptom relief medication. Zenyaku Kogyo's
ongoing research interests are focused on cancer, autoimmune
diseases, and antibody therapeutics. For additional information in
Japanese, please visit www.zenyaku.co.jp.
Safe Harbor Statement
Any statements contained in this press release that refer to
future events or other non-historical matters, including statements
that are preceded by, followed by, or that include such words as
"estimate," "intend," "anticipate," "believe," "plan," "goal,"
"expect," "project," or similar statements, are forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on Anthera's expectations as
of the date of this press release and are subject to certain risks
and uncertainties that could cause actual results to differ
materially as set forth in Anthera's public filings with the SEC,
including Anthera's Annual Report on Form 10-Q for the quarter
ended June 30, 2015. Anthera disclaims any intent or obligation to
update any forward-looking statements, whether because of new
information, future events or otherwise, except as required by
applicable law.
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510.856.5600x5621
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From Apr 2024 to May 2024
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From May 2023 to May 2024