Nordic Nanovector signs global clinical and commercial agreement with ITM for the supply of no-carrier-added Lutetium-177
Oslo, Norway, 7 October 2019
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:
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
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
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
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.