UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 11, 2014
ANTHERA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| |
|
|
|
|
|
Delaware
|
|
001-34637
|
|
20-1852016
|
|
(State or Other Jurisdiction of
Incorporation)
|
|
(Commission File Number)
|
|
(I.R.S. Employer
Identification No.)
|
| |
|
|
|
25801 Industrial Boulevard, Suite B, Hayward,
California
|
|
94545
|
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Registrant’s telephone number, including area code: (510) 856-5600
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01. Entry into a Material Definitive Agreement.
License Agreement
On December 11, 2014, Anthera Pharmaceuticals, Inc. (“Anthera” or the “Company”) entered into a license agreement (the “License Agreement”) with Zenyaku Kogyo Co., Ltd. (“Zenyaku”) pursuant to which the Company granted Zenyaku an exclusive license to certain patent rights, know-how and other intellectual property relating to blisibimod.
Under the agreement, Zenyaku obtained (i) exclusive rights to develop, use, sell, have sold, offer for sale and import blisibimod and any related products containing any of blisibimod’s binding domains, including but not limited to any pegylated (or otherwise chemically modified) blisibimod binding domain, (ii) certain rights to grant sublicenses and (iii) an option to expand the territory of the license to include China (including Hong Kong), Singapore, Taiwan, Philippines, Thailand, Malaysia, Vietnam, Indonesia and South Korea (“Additional Asian Countries”). The licensed patent rights include all patents controlled by Anthera or its affiliates relating to blisibimod, including those licensed to Anthera under that certain License Agreement dated December 18, 2007 between Anthera and Amgen Inc. (“Amgen”) as amended October 16, 2009 and November 26, 2014 (the “Amgen Agreement”). Anthera retained the right to practice and grant licenses relating to blisibimod technology in all areas outside of the licensed territory, to manufacture and have manufactured compounds and products relating to blisibmod anywhere in the world and to conduct or have conducted clinical trials and other studies of compounds and products relating to blisibmod anywhere in the world. The development activities of both Anthera and Zenyaku will be overseen by a joint development committee.
Under the terms of the License Agreement, Zenyaku assumes sole responsibility for the sale, marketing, promotion and commercialization of products relating to blisibimod in the licensed territory, and is obligated to use commercially reasonable efforts to market, promote, sell and commercialize licensed products in such territory.
The License Agreement provides that Zenyaku will make a forgivable loan to Anthera in the aggregate principal amount of $7,000,000. In exchange, Anthera will issue a Secured Promissory Note to Zenyaku (the “Note”). The Note accrues interest at the rate of 1% per annum and has a maturity date of December 11, 2021. $5,000,000 of the loan, together with interest thereon, shall be automatically forgiven upon certain achievement of the primary endpoint identified in the first Phase 3 Study for blisibimod to treat Immunoglobulin A Nephropathies in humans. Additionally, $2,000,000 of the loan, together with interest thereon, shall be automatically forgiven upon the submission of the first Biologics License Application for blisibimod in the licensed territory. The Note will be secured by certain information and material necessary for the manufacture of blisibimod. The License Agreement provides that Zenyaku will reimburse Anthera for i) 100% of blisibimod development cost in Japan; 2) a percentage of global blisibimod development cost outside of Japan; and 3) exclusive purchase of blisibimod clinical drug supplies at cost and blisibimod commercial drug products at premium from Anthera.
Zenyaku is also obligated to make the following milestone payments: (i) $5,000,000 for the first Biologics License Application approval of a product in the licensed territory, (ii) $2,000,000 for the first Biologics License Application approval of a product in the licensed territory for the first follow-on indication, (iii) $5,000,000 when the aggregate net sales of all products in Japan equal or exceed $150,000,000, (iv) $10,000,000 when the aggregate net sales of all products in Japan equal or exceed $250,000,000.
Pursuant to the License Agreement, the Company and Zenyaku have also entered into that certain Stock Purchase Agreement, dated December 11, 2014, under which, within 30 days of the agreement date, the Company may require Zenyaku to purchase up to $7,000,000 of shares of its common stock at a purchase price equal to 1.3 times the volume weighted average price of the Company’s common stock for 20 trading days prior to the delivery of the closing notice (the “Premium Purchase Price”). The Company may also require Zenyaku to purchase up to an additional $8,000,000 of shares of the Company’s common stock at the Premium Purchase Price in quarterly installments of no more than $2,000,000 during the period from June 1, 2015 to March 31, 2016. Additionally, prior to May 31, 2016, the Company may sell up to $4,000,000 of shares of the Company’s common stock to Zenyaku at the Premium Purchase Price should Zenyaku elects to exercise their option for the Additional Asian Countries. All sales under the Stock Purchase Agreement are subject to the condition that Zenyaku will not at any time be obligated to purchase such number of shares of common stock that would result in Zenyaku being the beneficial owner of more than 15% of the Company’s issued and outstanding shares of common stock.
In connection with the License Agreement, the Company also amended the Amgen Agreement to (i) adjust certain royalty and milestone payment obligations payable to Amgen in light of the anticipated collaboration between Anthera and Zenyaku and (ii) to provide that the sublicense granted by Anthera to Zenyaku shall survive the termination of the Amgen Agreement. Under this amendment, Anthera also agreed to grant Amgen that number of shares of its common stock equal $1,000,000 divided by the volume weighted average price of the Company’s common stock for 20 trading days prior to issuance.
The Company issued a press release on December 15, 2014 announcing its entry into the License Agreement. The press release is furnished hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following documents are furnished as exhibits to this report:
|
99.1
|
Press release dated December 15, 2014
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 16, 2014 |
Anthera Pharmaceuticals, Inc. |
|
| |
|
|
|
| |
|
|
|
|
|
By:
|
May Liu |
|
| |
|
May Liu
Principal Accounting Officer and Senior Vice
President, Finance and Administration
|
|
Exhibit 99.1
Anthera Pharmaceuticals Licenses Japan Rights for Blisibimod to Zenyaku Kogyo Co., Ltd.
|
|
·
|
Anthera to receive up to $48,000,000 plus future product margin on commercial supply
|
|
|
·
|
Zenyaku to reimburse Anthera for a portion of future blisibimod worldwide development costs
|
|
|
·
|
Zenyaku to assume full responsibility for development and associated costs in Japan and potentially other Asian territories in the future
|
|
|
·
|
Companies will collaborate on blisibimod development for both IgA Nephropathy (“IgAN”) and Systemic Lupus Erythematosus (“Lupus”)
|
December 15th, 2014: HAYWARD, CA – Anthera Pharmaceuticals, Inc. 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.
SOURCE: Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From Apr 2023 to Apr 2024
