Date: 2015-06-30
Type of information: Distribution agreement
Compound: Lutathera® (radiolabeled somatostatin analog)
Company: Advanced Accelerator Applications (France) FUJIFILM RI Pharma (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: distribution
Action mechanism: radiopharmaceutical/peptide analog. Lutathera®, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumor types. It acts like a Trojan horse, delivering [177]Lu directly into the tumour cell. [177]Lu is an instable particle that releases an electron which, as in radiotherapy, is capable of killing the tumors. It also releases a gamma ray, which exits the body and enables physicians to image and evaluate the progress of the treatment via a SPECT (Single Photon Emission Computed Tomography) camera. Lutathera® is an example of a theragnostic drug, since its efficacy can be evaluated and monitored using imaging at every therapeutic injection, without additional costs.
Disease: inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors
Details: * On June 30, 2015, Advanced Accelerator Applications, an international specialist in molecular nuclear medicine, announced that it has entered into a distribution agreement for Lutathera® in Japan with FUJIFILM RI Pharma, Co., LTD (“FRI”), a leading in-country distributor of nuclear medicine and diagnostic imaging products. Lutathera® is currently in a pivotal Phase III trial, both in the US and EU, with results expected in Q3. AAA and FRI will work together to meet all Japanese regulatory requirements and prepare for national approval. “In Europe’s five key markets and the US, AAA’s plan is to build complete and dedicated commercial structures in each country to support the launch and promotion of Lutathera and Somakit, Lutathera’s companion diagnostic, for which a New Drug Application (NDA) will soon be submitted to the FDA,” added Stefano Buono, CEO of Advanced Accelerator Applications.
Based on current evidence of efficacy and safety, Lutathera® is already available in 9 European countries (Austria, Denmark, Estonia, Finland, Greece, Portugal, Spain, Switzerland and the UK) under compassionate use or named patients programs and in France under a Cohort Temporary Authorization of Use (ATU de Cohorte).
Financial terms: As part of the agreement, AAA will receive launch and development milestone payments, in addition to royalties on product sales. Lutathera will be manufactured by AAA in Europe and sold to FRI by its subsidiary AAA International.
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