OSLO, Norway, Oct. 7, 2019 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) announces that it has signed a long-term global
supply agreement with a subsidiary of ITM Isotopen Technologien
München AG (ITM), Isotope Technologies Garching GmbH (ITG) to
ensure the supply of high quality, no-carrier-added (n.c.a.)
Lutetium-177, a key component of Betalutin®
(177Lu-lilotomab-satetraxetan) for R&D, clinical and
commercial uses.
ITM, a biotechnology and radiopharmaceutical group of companies
and world-leader in the development and production of
radiopharmaceuticals and radionuclides for the targeted treatment
of cancers as well as for diagnostics, has been supplying n.c.a.
Lutetium-177 (EndolucinBeta®)* to Nordic Nanovector since 2010.
Marco Renoldi, Chief Operating Officer at Nordic Nanovector,
said: "We are pleased to extend our collaboration with a long-time
and reliable partner such as ITM. This global supply agreement is a
key milestone in the implementation of our CMC (Chemistry,
Manufacturing and Controls) strategy for gaining regulatory
approval for Betalutin® and its subsequent commercial rollout, as
it provides certainty of continued supply of n.c.a. Lutetium-177
during clinical development as well as after launch. The agreement
with ITM, alongside other manufacturing supply and development
agreements in place with specialist manufacturers at all stages of
the manufacturing and supply chain for Betalutin® strengthens our
confidence in the ability to deliver a reliable and sustainable
supply chain in support of the launch of our lead asset."
Steffen Schuster, CEO of ITM,
added: "Nordic Nanovector is one of our longstanding partners and
we are delighted that Nordic Nanovector has reaffirmed their
confidence through this long-term supply agreement for
EndolucinBeta®. In addition to the development of our own pipeline,
we have once again been able to gain a strategic partner for the
development of targeted radiopharmaceuticals in Precision Oncology,
thereby making a significant contribution to advancing a promising
treatment option for difficult-to-treat cancers. With our
manufacturing facilities around the world and our unrivaled
logistics network, we feel well equipped to reliably meet our
partners' needs and to enter into further strategic
relationships."
*EndolucinBeta®, registered trademark of ITM's EMA approved
pharmaceutical n.c.a. Lutetium-177.
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate
Communications
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
International Media Enquiries
Mark Swallow/David
Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: nordicnanovector@citigatedewerogerson.com
About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative
therapies to patients to address major unmet medical needs and
advance cancer care. The Company aspires to become a leader in the
development of targeted therapies for haematological cancers.
Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a
novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an
indication with substantial unmet medical need, representing a
growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector intends
to retain marketing rights and to actively participate in the
commercialisation of Betalutin® in core markets. Further
information can be found at www.nordicnanovector.com
About EndolucinBeta®
EndolucinBeta® is a radiopharmaceutical precursor with a
half-life of 6.647 days, usable for radiolabeling of
disease-specific carrier molecules. The active substance of
EndolucinBeta® is no-carrier-added (n.c.a.) Lutetium
(177Lu) chloride. No-carrier-added 177Lu
provides the highest specific activity of more than 3,000 GBq/mg,
whereby the day of calibration can be flexibly selected by the
customer. Due to its high specific activity, optimal preconditions
for efficient radiolabeling of biomolecules over its entire
shelf-life of 9 days after production are ensured. Furthermore
EndolucinBeta® exhibits an extraordinary level of radionuclidic
purity. EndolucinBeta® does not contain metastable
177mLu, thus, there is no
need for cost intensive clinical waste management. Marketing
authorization holder of EndolucinBeta® is ITM's subsidiary ITG.
About ITM Isotopen Technologien München
ITM Isotopen Technologien München AG is a privately held
biotechnology and radiopharmaceutical group of companies dedicated
to the development, production and global supply of targeted
diagnostic and therapeutic radiopharmaceuticals and radionuclides
for use in cancer treatment. Since its foundation in 2004, ITM and
its subsidiaries have established GMP manufacturing and a robust
global supply network of innovative, first-in-class medical
radionuclides and generator platforms 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 tumors 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
This press release contains certain forward-looking statements.
These statements are based on management's current expectations and
are subject to uncertainty and changes in circumstances, since they
relate to events and depend on circumstances that will occur in the
future and which, by their nature, will have an impact on Nordic
Nanovector's business, financial condition and results of
operations. The terms "anticipates", "assumes", "believes", "can",
"could", "estimates", "expects", "forecasts", "intends", "may",
"might", "plans", "should", "projects", "targets", "will", "would"
or, in each case, their negative, or other variations or comparable
terminology are used to identify forward-looking statements. These
forward-looking statements are not historic facts. There are a
number of factors that could cause actual results and developments
to differ materially from those expressed or implied in the
forward-looking statements. Factors that could cause these
differences include, but are not limited to, risks associated with
implementation of Nordic Nanovector's strategy, risks and
uncertainties associated with the development and/or approval of
Nordic Nanovector's product candidates, ongoing and future clinical
trials and expected trial results, the ability to commercialise
Betalutin®, technology changes and new products in Nordic
Nanovector's potential market and industry, Nordic Nanovector's
freedom to operate (competitors patents) in respect of the products
it develops, the ability to develop new products and enhance
existing products, the impact of competition, changes in general
economy and industry conditions, and legislative, regulatory and
political factors. No assurance can be given that such expectations
will prove to have been correct. Nordic Nanovector disclaims any
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
This information is subject to a duty of disclosure pursuant to
Section 5-12 of the Securities Trading Act.
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