Endocyte and ITM Announce Long-Term Supply Agreement for No-Carrier-Added Lutetium-177
July 09 2018 - 8:00AM
Endocyte, Inc. (Nasdaq:ECYT), and ITM Isotopen Technologien München
AG (ITM), a specialized radiopharmaceutical group of companies,
announced today that ITM´s subsidiary, Isotope Technologies
Garching GmbH (ITG), and Endocyte have signed a long-term global
supply agreement for the highly purified, no-carrier-added
Lutetium-177 (177Lu) EndolucinBeta® to support clinical and
commercial supply of 177Lu-PSMA-617, through 2035.
“We are pleased to secure this long-term strategic partnership
to ensure a reliable supply of no-carrier-added Lutetium-177
through commercialization,” said Mike Sherman, president and CEO of
Endocyte. “This agreement broadens and extends the supply agreement
with ITG that we established earlier this year, supporting our
ongoing phase 3 VISION trial of 177Lu-PSMA-617 for the treatment of
advanced prostate cancer.”
Under the terms of the supply agreement, ITG will provide
Endocyte with 100% of the Lutetium-177 required for the phase 3
VISION trial. ITG also will provide at least 50% and up to 100% of
commercial supply at Endocyte’s request. Endocyte will pay €5
million up-front to support the company´s ongoing expansion of
worldwide manufacturing capacity for Lutetium-177. Additional terms
of the agreement are not disclosed.
“We are pleased to extend our collaboration with Endocyte as a
trusted partner while they develop this important potential therapy
for patients with advanced prostate cancer,” said Steffen Schuster,
CEO of ITM. “We believe ITM is already well positioned to support
the completion of Endocyte’s VISION trial and we are preparing to
support the potential global commercialization of this therapy.
With multiple manufacturing facilities around the world and an
unrivaled logistics network, we are confident we will reliably meet
the needs for this significant opportunity.”
Website Information
Endocyte routinely posts important information
for investors on its website, www.endocyte.com, in the “Investors
& News” section. Endocyte uses this website as a means of
disclosing material information in compliance with its disclosure
obligations under Regulation FD. Accordingly, investors should
monitor the “Investors & News” section of Endocyte’s website,
in addition to following its press releases, SEC filings, public
conference calls, presentations and webcasts. The information
contained on, or that may be accessed through, Endocyte’s website
is not incorporated by reference into, and is not a part of, this
document.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing
targeted therapies for the personalized treatment of cancer. The
company's drug conjugation technology targets therapeutics and
companion imaging agents specifically to the site of diseased
cells. Endocyte's lead program is a prostate specific membrane
antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, in
phase 3 for metastatic castration-resistant prostate cancer
(mCRPC). Endocyte also expects to have an Investigational New Drug
application submitted in the fourth quarter of 2018 for its
adaptor-controlled CAR T-cell therapy which will be studied
initially in osteosarcoma. For additional information, please visit
Endocyte's website at www.endocyte.com.
About ITM (ITM
Isotopen Technologien München AG)ITM Isotopen Technologien
München AG is a privately held group of companies dedicated to the
development, production and global supply of innovative diagnostic
and therapeutic radionuclides and radiopharmaceuticals. Since its
foundation in 2004, ITM and its subsidiaries have established GMP
manufacturing and a robust global supply network of novel,
first-in-class medical radionuclides and generator platform for a
new generation of targeted cancer diagnostics and therapies.
Furthermore, ITM is developing a proprietary portfolio and growing
pipeline of targeted treatments in various stages of clinical
development, which address a range of cancers such as
neuroendocrine cancers and bone metastases. ITM’s main objectives,
together with its scientific, medical and industrial collaboration
partners worldwide, are to significantly improve outcomes and
quality of life for cancer patients while at the same time reducing
side-effects and improving health economics through a new
generation of Targeted Radionuclide Therapies in Precision
Oncology. For more information about ITM, please visit:
www.itm.ag
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the Endocyte’s
future development plans including those relating to the completion
of pre-clinical development in preparation for possible future
clinical trials, the anticipated initiation of a registration
trial, and preparation for potential commercialization. Actual
results or developments may differ materially from those projected
or implied in these forward-looking statements. Factors that may
cause such a difference include risks that the company or
independent investigators may experience delays in the initiation
or completion of clinical trials (whether caused by competition,
adverse events, patient enrollment rates, shortage of clinical
trial materials, regulatory issues or other factors); risks that
data from prior clinical trials may not be indicative of subsequent
clinical trial results; risks related to the safety and efficacy of
the company’s product candidates; risks that early stage
pre-clinical data may not be indicative of subsequent data when
expanded to additional pre-clinical models or to subsequent
clinical data; risks that evolving competitive activity and
intellectual property landscape may impair the company's ability to
capture value for the technology; risks that expectations and
estimates turn out to be incorrect, including estimates of the
potential markets for the company’s product candidates, estimates
of the capacity of manufacturing and other facilities required to
support its product candidates, supply chain issues of any type,
including timing of supply, projected cash needs, and expected
future revenues, operations, expenditures and cash position. More
information about the risks and uncertainties faced by Endocyte,
Inc. is contained in the company’s periodic reports filed with the
Securities and Exchange Commission. Endocyte, Inc. disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Endocyte Investor Contact:Michael Schaffzin,
Stern Investor Relations, Inc., (212) 362-1200,
michael@sternir.com
ITM Media Contact:Nicola ScharrerHead of
MarketingPhone: +49 89 3298986-16Email: Nicola.Scharrer@itm.ag
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