HAYWARD, Calif., Dec. 15, 2014 /PRNewswire/ -- Anthera
Pharmaceuticals, Inc. (Nasdaq: ANTH) announced today that
Anthera and Zenyaku Kogyo Co., Ltd. of Tokyo, Japan 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."
"We are pleased to expand our B-cell target product portfolio
with blisibimod, a potent BAFF inhibitor which down regulates
abnormal B-cell development, to strengthen our commitment to
provide useful therapeutics for treatment of diseases with unmet
medical need," said Koichi
Hashimoto, President and Chief Executive Officer of Zenyaku
Kogyo Co., Ltd.
"We are excited to enter into this partnership with Zenyaku
Kogyo," said Colin Hislop, MD,
Anthera's Chief Medical Officer. "IgA nephropathy is a prevalent
disease in Asia, and particularly
Japan, and many patients
eventually progress to end-stage renal disease in spite of
aggressive treatment. Zenyaku's extensive expertise in
immunological pharmaceutical development and marketing in
Japan, combined with blisibimod's
potential role in addressing this unmet medical need, makes us
ideal partners to bring this therapy to patients."
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. Clarity Point
Partners, L.L.C. (www.claritypp.com) acted as the lead advisor to
Anthera.
Anthera will host a conference call to discuss this news
release, other market developments, and answer investor
questions.
Conference ID: 53085075
Date of call: 12/15/2014
Time of call: 16:30 Eastern Time
Expected Duration: 30 minutes
Conference Dial-In Numbers:
Participant Toll-Free Dial-In Number: (855) 226-3021
Participant International Dial-In Number: (315) 625-6892
About Anthera Pharmaceuticals
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.
About Blisibimod
Anthera is developing blisibimod, 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. Multiple clinical studies with BAFF antagonists
have reported the potential benefit of BAFF inhibitors in treating
patients with lupus and IgAN.
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. 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-K for the year ended
December 31, 2013 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2014. 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: Dennis Lutz of Anthera
Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598.
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SOURCE Anthera Pharmaceuticals, Inc.