Regner med at noen, men på langt nær alle, har lest årsrapporten.

Her er et utdrag (side 42) som beskriver hvordan selskapet pr i dag rigger seg for å bli kommersielle.

Det er ikke så vanskelig å tolke dette dithen at ledelsen og dets nærmeste partnere forstår i langt større grad enn markedet hvor dette bærer hen, og hvorfor selskapet gjør de disponeringer de gjør med tanke på kommersialisering av Betalutin.

Pre-commercialisation research: defining the commercialisation strategy:

In parallel with the clinical development programme for Betalutin®, Nordic Nanovector has been building its knowledge base to enable the design of its
commercialisation strategy for Betalutin® in 3L FL and more broadly in NHL.
Extensive market research has been undertaken to understand the competitive environment in NHL and what customers perceiveas the areas of unmet needs. This research confirmed that the value of Betalutin® is distinctly perceived by customers across all prioritised segments: efficacy is seen as a major strength, but what really enthuses Haematologist-Oncologists (HaemOncs) is the “bundle” of potential benefits, including efficacy, manageable toxicity and simplicity for patients and physicians.

This attractive profile positions Betalutin® competitively to serve the unmet needs of patients who are frail or elderly, have co-morbidities that rule out chemotherapy, or who are refractory to rituximab.

Market research has also been completed to understand the changes in the US healthcare environment and how they affect the process through which HaemOncs, who are responsible for NHL patients, can refer a patient to a radiation oncologist (RadOnc) or a Nuclear Medicine (NM) specialist to receive a radiopharmaceutical product (referral pathway), when they are convinced it is the preferred option. The results have equipped the company with valuable knowledge about the US healthcare environment, the NHL market and target customers.

Furthermore, the outcome of case studies suggests clearly that Betalutin®, as a next-generation radioimmunotherapy, can become a commercially successful therapeutic option, provided certain prerequisites are met: (a) scientific engagement of thought leaders in key institutions ahead of commercial launch; (b) well-designed clinical development plan; (c) robust market access and reimbursement programme; (d) optimised referral pathway; and (e) streamlined distribution via a centralised logistics service to customers.

Nordic Nanovector is committed to leverage these insights to develop strategies that offer the best chance of commercial success for Betalutin®.

Manufacturing

The company uses external contract manufacturing organizations ("CMO's") to manufacture the antibody lilotomab and Betalutin®. The company has employed experienced personnel, capable of directing work that is performed by the CMO's. This approach to product development allows for a quick change of research directions and efforts when needed and to quickly bring in new technologies and expertise when necessary.
The production of the crude lilotomab is carried out in Oslo, Norway and the antibody is then purified and conjugated in Spain.

The production process for Betalutin® is well-documented and clinical supplies are manufactured according to existing good manufacturing practice ("GMP") in Norway. The product is shipped from there to the clinical trial sites world-wide.

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Selskapet understreker at de vil ta US alene, og se etter samarbeid i Europa. Intet nytt for de som har fulgt med, men en bekreftelse på en fornuftig strategi.