Immunomedics and Everest Medicines Announce Exclusive License Agreement for Sacituzumab Govitecan in East and Southeast Asia Excluding Japan

Apr  2019

The Largest Single-Asset License Agreement for Greater China To Date Provides Everest Medicines the Right to Develop

MORRIS PLAINS, N.J.  and  NEW YORK,  April 29,  2019  (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area  of antibody-drug conjugates (ADC) and Everest Medicines  II   Limited   (“Everest   Medicines”),   a   C-Bridge   Capital-backed biopharmaceutical  company,  today   announced  an   exclusive license  agreement  to develop,  register,  and  commercialize sacituzumab govitecan in Greater  China, South Korea and certain Southeast Asian countries (Territory).


“We   are    pleased  to   be   partnering   with   Everest    Medicines   to   commercialize sacituzumab  govitecan in the  Asian  market outside Japan  and  further  develop   the product in solid  tumor  indications of  high  unmet need  in the  territory,”  said  Usama Malik,  Chief  Financial   Ocer  and   Chief  Business Ocer  of  Immunomedics.   “This agreement sets a new  benchmark for a single-asset licensing deal  for regional  China and exemplies our commitment to expand the geographic footprint and clinical use  of sacituzumab govitecan for the benet of cancer patients worldwide.”


“Sacituzumab govitecan is an innovative  and unique  ADC with a highly favorable clinical benet rate  across solid  tumors and  provides us  the  opportunity to  address hard  to treat  cancers in key underserved regions across Asia.   We look forward  to partnering with Immunomedics’ clinical  and  regulatory teams  to  accelerate the  development of sacituzumab  govitecan across  multiple  indications in  Greater   China  where  there   is great  need  for  innovative  cancer therapeutics of  major  impact,”  said  Eric Rowinsky, M.D., U.S. Chief Medical  Ocer for Oncology, and  Yang Shi, M.D., China Chief Medical Ocer for Oncology of Everest  Medicines.


Immunomedics will receive  an  upfront  payment of $65  million and  an  additional $60 million  based on  U.S. FDA approval of  sacituzumab  govitecan in  metastatic  triple- negative breast cancer. Everest  will develop  and  commercialize the  product in various global  and  local  indications across the  Territory.  The  Company is  eligible  to  receive development and sales milestone payments of up to $710  million, as well as escalating tiered royalties that begin in the mid-teens based on net sales within the Territory.


Pursuant  to   the   agreement,  Everest   Medicines  will  be   responsible  for  all  costs associated  with  the   clinical   development  and   commercialization  of  sacituzumab govitecan in the Territory, while a Joint  Steering Committee will be established between the companies to oversee the overall strategy and priorities.


“This  transformative deal  reinforces Everest   Medicines’   position as the  preeminent biopharmaceutical   company   to   develop    and    commercialize   globally   innovative products in Greater  China  and  other  emerging Asia  Pacic  markets,”  said  Ian  Woo, President and Chief Financial  Ocer of Everest  Medicines.


“Everest  Medicines’  highly experienced team has  a  proven  track  record  of delivering industry  leading  execution and  we look forward  to leveraging our deep  knowledge and cumulative insights to address diseases with unmet need  that  are  highly prevalent  in these underserved regions,” said Sean  Cao, Interim CEO of Everest  Medicines.


“Today’s announcement culminates a thoughtful and deliberate process, that  expedites regional  expansion of our lead  product candidate in the world’s fastest growing pharmaceutical market and  signicantly enhances shareholder value.  This partnership allows  the  Company to continue on its  path  to becoming a global  biopharmaceutical company,  and  importantly maintaining  the  strategic  optionality in  core  established markets worldwide,” said  Behzad  Aghazadeh, Chairman of the Board of Directors  of Immunomedics.


About Sacituzumab  Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, rst-in-class antibody-drug conjugate targeting the Trop-2 receptor expressed by many solid  cancers and  delivering  the  moderately-toxic drug,  SN-38, directly  to  the  tumor. Sacituzumab govitecan has  received Breakthrough Therapy  Designation from  the  U.S. Food  and  Drug  Administration  for  the  treatment of  patients with  metastatic  triple- negative breast cancer who have received two prior therapies for metastatic disease.


About Everest Medicines

Everest  Medicines is a  C-Bridge Capital-backed biopharmaceutical company focused on   developing  and   commercializing transformative pharmaceutical products  that address critical  unmet medical needs for  patients in Greater  China  and  other  Asian markets. The  management team of  Everest   Medicines has   deep   expertise and  an extensive track  record   of  high-quality  clinical  development,  regulatory affairs,  CMC, business development and  operations both  in China  and  with  leading  global pharmaceutical companies. For  more   information, please  visit  its website at www.everestmedicines.com.


About Immunomedics

Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based  products  for   the   targeted  treatment  of   cancer.   Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and  a leader   in  the  eld  of  antibody-drug conjugates.  For  additional  information  on  the Company, please visit its website at  https://immunomedics.com/. The information on its website does not, however, form a part of this press release.


Cautionary note regarding forward-looking statements

This   release,  in  addition  to   historical  information,  may   contain  forward-looking statements  made pursuant to  the  Private  Securities Litigation  Reform  Act  of  1995. Such   statements,  including   statements   regarding expectations  for  the   timing   or outcome of  our anticipated meeting with the  FDA to discuss the  Complete Response Letter  received in response to our BLA for sacituzumab govitecan for the treatment of patients with metastatic  triple-negative breast cancer (mTNBC) who  have  received at least two prior therapies for metastatic disease, and  expectations for the  related resubmission, the FDA re-inspection of the Company’s manufacturing facility where  we manufacture the  monoclonal antibody for further  manufacture into our antibody-drug- conjugate candidate sacituzumab govitecan, potential approval and commercial launch of sacituzumab govitecan for that  indication and  the  Company’s development of sacituzumab govitecan for additional indications, clinical  trials  (including  the  funding therefor,  anticipated  patient enrollment, trial  outcomes, timing  or  associated costs), regulatory applications and related timelines, including the ling and approval timelines for  BLAs, BLA resubmissions, and  BLA supplements,  out-licensing arrangements, forecasts of future  operating results, potential collaborations, capital  raising  activities, and  the  timing  for bringing  any product candidate to  market,  involve signicant risks and  uncertainties and  actual results could  differ  materially  from  those expressed or implied herein.  Factors that could cause such  differences include, but are not limited to, the Company’s reliance on third-party  relationships and  outsourcing arrangements  (for example in connection with  manufacturing, logistics and  distribution, and  sales and marketing) over which it may not always  have  full control,  including  the  failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational or commercial products and, or to comply with the Company’s agreements or laws  and  regulations that  impact the  Company’s business; the Company’s ability to meet pre- or post-approval compliance obligations; imposition of   signicant  post-approval  regulatory  requirements   on   our   product  candidates, including  a  requirement for  a  post-approval conrmatory clinical  study,  or  failure  to maintain or  obtain  full regulatory approval for  the  Company’s  product candidates, if received,  due  to a failure to satisfy post-approval regulatory requirements, such  as the submission of  sucient data   from  a  conrmatory clinical  study;  the  uncertainties inherent in  research and  development; safety  and  ecacy   concerns  related to  the Company’s  products and  product candidates; uncertainties in the  rate  and  degree of market acceptance of products and  product candidates, if approved; inability to create an  effective direct  sales and  marketing infrastructure or to  partner with third  parties that offer such  an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment population for the Company’s products and product candidates; decisions by regulatory  authorities  regarding  labeling   and   other   matters  that   could   affect  the availability or commercial potential of the Company’s products and product candidates; the   Company’s  dependence  on  business  collaborations or  availability   of  required nancing from capital  markets, or other  sources on acceptable terms,  if at all, in order to further  develop  our products and  nance our operations; new product development (including  clinical trials outcome and regulatory requirements/actions); the risk that  we or any of our collaborators may be unable  to secure regulatory approval of and  market our drug  candidates; risks  associated with litigation  to which  the  Company is or may become a party,  including  the  cost and  potential reputational damage resulting from such  litigation; loss of key personnel; competitive risks  to marketed products; and  the Company’s ability to repay  its outstanding indebtedness, if and  when  required,  as well as the risks  discussed in the  Company’s lings with the  Securities and  Exchange Commission. The Company is not under  any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result  of new information, future events or otherwise.


Investor Contact: Dr. Chau Cheng (862) 260-3727

ccheng@immunomedics.com

 

Media Contact: Lauren Wood (862) 260-3631

lwood@immunomedics.com

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