EPIRUS BIOPHARMACEUTICALS, INC.

Transcription

1 EPIRUS BIOPHARMACEUTICALS, INC. FORM 8-K (Current report filing) Filed 09/29/14 for the Period Ending 09/24/14 Address 699 BOYLSTON ST 8TH FLOOR BOSTON, MA Telephone (617) CIK Symbol EPRS SIC Code Pharmaceutical Preparations Industry Biotechnology & Drugs Sector Healthcare Fiscal Year 12/31 Copyright 2016, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.

2 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C 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): September 24, 2014 EPIRUS BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction (Commission (I.R.S. Employer of Incorporation) File Number) Identification No.) 699 Boylston Street Eighth Floor Boston, MA (Address of Principal Executive Offices) (Zip Code) Registrant s telephone number, including area code: (617) 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: Written communications pursuant to Rule 425 under the Securities Act (17 CFR ) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-4(c))

3 Item 1.01 Entry into a Material Definitive Agreement. Livzon Collaboration Agreement On September 24, 2014, Epirus Switzerland GmbH ( Epirus ), a wholly-owned subsidiary of EPIRUS Biopharmaceuticals, Inc. (together with its subsidiaries, the Company ), entered into an Exclusive License and Collaboration Agreement (the Agreement ) with Livzon Mabpharm Inc. ( Livzon ) for the global development and commercialization of certain antibodies or related biological compounds, including the Company s BOW015, a biosimilar version of infliximab. Under the Agreement, Epirus and Livzon each granted the other party, in the other party s territory, exclusive, royalty-bearing licenses under certain patent rights and know-how to develop, manufacture and commercialize BOW015 and up to four additional compounds chosen by mutual agreement of the parties (collectively, the Collaboration Compounds ). Livzon s territory consists of China, Hong Kong, Macau and Taiwan (the Livzon Territory ), and the Company s territory consists of the rest of the world. The parties share pre-clinical development expenses for each Collaboration Compound based on certain factors specific to each compound. Each party bears the responsibility and expenses for clinical development and commercialization of each Collaboration Compound in its territory. Livzon will be the preferred supplier of each Collaboration Compound for pre-clinical, clinical, and commercialization purposes, subject to Livzon s satisfaction of certain performance criteria. In consideration for the license granted to Livzon to develop and commercialize BOW015, the Company is eligible to receive from Livzon a milestone payment of $2.5 million upon the achievement of a specified regulatory milestone in the Livzon Territory. The Company is also eligible to receive from Livzon tiered royalties based on a percentage of net sales of BOW015 products in the Livzon Territory ranging from the low- to high- single digits. Any future Collaboration Compounds have cross-milestone and royalty obligations in amounts to be mutually agreed upon at a later date. If not terminated earlier or extended by mutual agreement of the parties, the Agreement expires in its entirety twenty years from the effective date. Either party may terminate the agreement for any material breach by the other party that is not cured within a specified time period. Either party may also terminate the Agreement upon bankruptcy or insolvency of the other party or if the other party challenges any of the patents licensed to it under the Agreement. Amendment to Revenue and Negotiation Rights Agreement On September 24, 2014, the Company entered into an amendment (the Amendment ) to that certain Revenue and Negotiation Rights Agreement between the Company and Moksha8 Pharmaceuticals, Inc. ( Moksha8 ), dated as of December 31, 2010 (the Moksha8 Revenue Agreement ). Under the terms of the Moksha8 Revenue Agreement, the Company was required to pay to Moksha8 royalties based on nets sales of BOW015 by Epirus or its affiliates at a percentage in the very low double digits, and a portion of all licensing revenue received by Epirus from third parties to commercialize BOW015 at a percentage in the mid-teens, subject in each case to reduction in certain circumstances. The Moksha8 Revenue Agreement is further described in the Company s Quarterly Report on Form 10-Q for its quarter ended June 30, The Amendment amends the Moksha8 Revenue Agreement to terminate the Company s payment obligations with respect to products that are biosimilars to infliximab, which includes the Company s BOW015 product, in exchange for the Company s payment of $1.5 million in two installments. The foregoing description is a summary and is qualified in its entirety by reference to the full text of the Amendment, which is attached hereto as Exhibit 10.1 and incorporated herein by reference. 2

4 Item 7.01 Regulation FD. On September 25, 2014, the Company issued a press release announcing the execution of the Agreement. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 10.1 First Amendment to the Revenue and Negotiation Rights Agreement, dated as of September 24, 2014, by and between Epirus Switzerland GmbH and Moksha8 Pharmaceuticals, Inc Press release of EPIRUS Biopharmaceuticals, Inc. dated September 25,

5 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: September 29, EPIRUS BIOPHARMACEUTICALS, INC. By: /s/ Amit Munshi Name: Amit Munshi Title: President and Chief Executive Officer

6 EXHIBIT INDEX Exhibit Number Description 10.1 First Amendment to the Revenue and Negotiation Rights Agreement, dated as of September 24, 2014, by and between Epirus Switzerland GmbH and Moksha8 Pharmaceuticals, Inc Press release of EPIRUS Biopharmaceuticals, Inc. dated September 25,

7 By this private instrument, the Parties, FIRST AMENDMENT TO THE REVENUE AND NEGOTIATION RIGHTS AGREEMENT Exhibit 10.1 EXECUTION VERSION EPIRUS SWITZERLAND GMBH, a corporation organized under the laws of Switzerland, with registered office at General-Guisan-Strasse 6, 6303 Zug Switzerland (hereinafter referred to as EPIRUS ), and as a successor to FOURTEEN22, INC. ( FOURTEEN22 ), represented herein by its undersigned legal representative(s), and MOKSHA8 PHARMACEUTICALS, INC., a Delaware corporation with registered office at 1550 Liberty Ridge Drive, Suite 300, Wayne, PA (hereinafter referred to as MOKSHA8 ), represented herein by its undersigned legal representative(s), MOKSHA8 and EPIRUS referred to herein individually as a Party and collectively as the Parties, hereby amend the Revenue and Negotiation Rights Agreement entered into between the Parties on December 31, 2010 (the Agreement ; capitalized terms used herein without definition shall have the meanings given to them in the Agreement): THE PARTIES HEREIN AGREE to enter into this First Amendment to the Agreement, which shall be governed by the following provisions: 1. EPIRUS Buyout of World-wide Revenue Sharing Payments for the 015 Product. In exchange for the payments pursuant to Clause 2 below, the Parties agree that all payment obligations of EPIRUS under Article 2 of the Agreement in respect of the 015 Product shall be irrevocably extinguished and deemed paid in full, including amounts payable under (i) Section 2.1(c) of the Agreement in respect of any past or future Net Sales of the 015 Product by EPIRUS or its Affiliates, and (ii) Section 2.2(c) of the Agreement in respect of any past or future Licensing Revenue received by EPIRUS or its Affiliates for the 015 Product, in each case for all such amounts that would otherwise be payable under the Agreement in respect of any Net Sales and/or Licensing Revenue generated in the Territory for the 015 Product. 2. As full and valid consideration for the world-wide buyout of the 015 Product revenue sharing payments pursuant to Clause 1 above, EPIRUS shall pay to MOKSHA8 a total amount of 1.5 million US Dollars (USD 1,500,000.00) in two (2) installments: (a) Seven hundred and fifty thousand US Dollars (USD 750,000.00) within ten (10) days following the execution of this First Amendment; and (b) Seven hundred and fifty thousand US Dollars (USD 750,000.00) within ten (10) days following EPIRUS closing of its next Form S3 registered offering of common stock and, in any event, by no later than December 31, 2014.

8 3. The payments in Clause 2 shall be made by means of transfer to a bank account to be appointed by MOKSHA8 in writing. The evidence of the order of transfer to the MOKSHA8 bank account of the amount corresponded to the payments shall be considered receipt. For the avoidance of doubt, the Parties agree that (i) the payments in Clause 2 will be non-refundable, and (ii) pending the payment of the second installment amount under Clause 2(b) above, no revenue sharing payment in respect of the 015 Product shall be due or payable by EPIRUS under the Agreement, subject to its payment of such second installment amount as provided hereunder. 4. This Amendment shall be effective as of September 24, 2014 (the Amendment Effective Date ). 5. The Agreement, including all Exhibits thereto and this First Amendment constitute the entire agreement between the Parties in relation to the subject matter thereof and supersede all other prior and contemporaneous communications, negotiations, arrangements and agreements between the Parties, whether oral or in writing. Except for the provisions of the Agreement expressly amended by this Amendment, the remainder of the Agreement shall remain in full force and effect as provided therein. 6. This Amendment shall be deemed to have been drafted by both Parties, and ambiguities, if any, shall not be construed against either Party. 7. This First Amendment may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 8. The validity, performance, construction and effect of this Amendment shall be governed by the laws of the State of New York, without regard to any conflicts of laws principles. IN WITNESS WHEREOF, the Parties execute this First Amendment to the Agreement by each of their duly authorized representatives. [Signature page follows] 2

9 EPIRUS SWITZERLAND GMBH /s/ Amit Munshi Name: Amit Munshi Title: President & CEO MOKSHA8 PHARMACEUTICALS, INC. /s/ AG Howarth Name: AG Howarth Title: CFO 3

10 Exhibit 99.1 EPIRUS and Livzon Mabpharm, Inc. Enter Collaboration Agreement for China Partners to develop, manufacture and commercialize up to five biosimilars, including EPIRUS BOW015, for Asian markets BOSTON, September 25, EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ: EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has signed a royalty-bearing, multi-product collaboration agreement with Livzon Mabpharm Inc. (Livzon), a Chinese biotechnology company focused on the development, manufacture, and sale of antibody-based drugs. Livzon was also a principal investor in the $36 million private financing round EPIRUS closed in April 2014, prior to becoming a public company. Under the terms of the agreement, EPIRUS and Livzon will work together to develop, manufacture, and commercialize up to five biosimilar products. The first collaboration product is EPIRUS Remicade biosimilar BOW015 (infliximab), which was recently approved in India. Livzon will conduct any additional development work necessary for the approval of BOW015 in China and Taiwan. Livzon will also serve as the preferred supplier of BOW015 in these territories, following a transfer of EPIRUS SCALE manufacturing platform. Livzon will be responsible for all commercialization activities in its territories. We have established a significant collaboration with a strong partner in a compelling market, said Amit Munshi, president and CEO of EPIRUS. This agreement also reinforces the importance of our SCALE manufacturing platform for in market production globally. Daotian Fu, Ph.D., CEO of Livzon Mabpharm, Inc., said, EPIRUS robust pipeline, business strategy and experienced management coupled with the market potential of biosimilars, made this an exciting collaboration for Livzon. We look forward to building a substantial biosimilars business for the China market. Dr. Fu is also a member of the EPIRUS board of directors. About EPIRUS EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates Remicade, Humira, and Avastin, respectively together generated $26.2 billion in global sales in

11 EPIRUS strategy for commercial success relies on targeted approaches for diverse global markets. For emerging markets with accessible regulatory frameworks for biosimilars, EPIRUS develops partnerships with local companies to accelerate regulatory approval and commercialize its products. For high-growth global markets where local manufacturing confers strategic and operational advantages, EPIRUS intends to use its SCALE platform to deliver an In Market, For Market manufacturing solution with local partners. For large markets with an established biosimilar regulatory framework, such as Europe, EPIRUS plans to commercialize its products using a combination of direct sales and local distributors. More information about EPIRUS can be found at About BOW015 BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial previously met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity. Recently, Epirus announced 58 week data for its Phase 3 trial, which demonstrated therapeutic equivalence to Remicade and confirmed the safety of switching from Remicade to BOW015. More data on the Phase 3 study is available at EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted global markets. EPIRUS also plans to initiate an additional Phase 3 trial in Europe in early About Livzon Mabpharm, Inc. Founded in 2010, Livzon Mabpharm, Inc. is one of the major biotechnology companies to enter biologics research and development in China. It is mainly focused on development, manufacturing and sale of antibody-based drugs. It is equipped with a world-class technical and scientific research team, core technology platforms, and advanced R&D facilities. The company s controlling shareholder is Livzon Pharmaceutical Group, Inc. ( Livzon, a pharmaceutical 2

12 listed company in Mainland China and in Hong Kong (Stock code: sz, HK)), which holds 51% shares of Livzon Mabpharm, Inc. Livzon is a diversified pharmaceutical enterprise integrating development & research, production and sales of pharmaceutical products, operating to manufacture drug products, bulk medicines and intermediates, as well as diagnostic reagents and equipment. Livzon Mabpharm, Inc. was founded as the strategic R&D transformation of Livzon Pharmaceutical Group. Inc., focusing on development of antibody based drugs and vaccines. More information about Livzon can be found at Forward Looking Statements Any statements made herein relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including the development and prospects of BOW015 and EPIRUS collaboration with Livzon, are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of In addition, when or if used in this document, the words may, could, should, anticipate, believe, estimate, expect, intend, plan, predict and similar expressions and their variants, as they relate to EPIRUS or its management, before or after the recent Zalicus merger, may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect EPIRUS business, financial conditions and results of operations are contained in EPIRUS filings with the U.S. Securities and Exchange Commission, which are available at Other risks and uncertainties are more fully described in EPIRUS filings with the U.S. Securities and Exchange Commission, which are available at Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made herein speak only as of the date stated herein, and subsequent events and developments may cause EPIRUS expectations and beliefs to change. 3

13 While EPIRUS may elect to update these forward-looking statements publicly at some point in the future, EPIRUS specifically disclaims any duty or obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forwardlooking statements should not be relied upon as representing EPIRUS views as of any date after the date stated herein. ### 4

14 For Inquiries: Russo Partners LLC Tony Russo, or Andrea Flynn, Remicade is a registered trademark of Johnson and Johnson ( Humira is a registered trademark of AbbVie ( Avastin is a registered trademark of Genentech ( 5