Immunomedics Announces Promotion Agreement With Janssen for Erdafitinib in the U.S.
April 08 2019 - 9:00AM
Immunomedics, Inc.,
(NASDAQ:
IMMU) (“Immunomedics” or the “Company”), a leading
biopharmaceutical company in the area of antibody-drug conjugates
(ADC), today announced that it has entered into a promotion
agreement in which Immunomedics will provide detailing services
to Janssen Biotech Inc. (Janssen), for erdafitinib in the
U.S.
“We are delighted to be collaborating with
Janssen and we look forward to working closely with the Janssen
team to help promote erdafitinib," said Brendan Delaney, Chief
Commercial Officer of Immunomedics. “We have built strong
commercial capabilities at Immunomedics and this agreement allows
us to leverage our experienced oncology sales force to educate the
U.S. market on this potential new treatment option for patients
with metastatic urothelial cancer upon FDA approval.”
Under the terms of the agreement, Immunomedics’
sales team will provide product detailing from the launch of
erdafitinib until the end of the First Quarter 2020, but only
requires Immunomedics to support the product in first position
detail until the FDA approval of sacituzumab govitecan.
Immunomedics is eligible to receive low double digit
royalties and milestone payments based on U.S. sales throughout
2019 and 2020, subject to sales thresholds in each year,
respectively.
A New Drug Application (NDA) for erdafitinib is
currently under review by the U.S. Food and Drug Administration for
the treatment of patients with locally advanced or metastatic
urothelial cancer and certain fibroblast growth factor receptor
(FGFR) genetic alterations whose tumors have progressed after prior
chemotherapy. Erdafitinib is an investigational, once-daily,
pan-FGFR kinase inhibitor that received Breakthrough Therapy
Designation from the FDA in March 2018.
About ImmunomedicsImmunomedics
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 field 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 statementsThis 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 filing 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 significant 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 significant
post-approval regulatory requirements on our product candidates,
including a requirement for a post-approval confirmatory 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 sufficient data from a confirmatory clinical study;
the uncertainties inherent in research and development; safety and
efficacy 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
financing from capital markets, or other sources on acceptable
terms, if at all, in order to further develop our products and
finance 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 filings 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: |
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Media Contact: |
Dr. Chau Cheng |
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Lauren Wood |
(973) 531-9123 |
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(973) 531-9287 |
ccheng@immunomedics.com |
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lwood@immunomedics.com |
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