On December 11, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca* (Press release, Innate Pharma, DEC 11, 2020, View Source [SID1234572642]). Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.
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The companies will develop a transition plan, including costs and transfer of the US marketing authorization and distribution of Lumoxiti back to AstraZeneca in 2021. AstraZeneca will remain the marketing authorization applicant for the EU filing.
"Since in-licensing Lumoxiti from AstraZeneca, we have been committed to delivering this medicine to patients and healthcare professionals in the US, and moving towards commercialization in the EU. However, we’ve determined that there is low strategic value for us in maintaining Lumoxiti in our portfolio due to lower than anticipated product sales, further compounded by the ongoing COVID-19 pandemic. This has led us to make the decision to re-prioritize our investments in our R&D portfolio," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We will continue to embed a commercial mindset into our R&D programs, which is a key success factor for the development and future commercialization of our pipeline assets."
As part of this decision, Innate will immediately begin to reduce its US commercial operations; however, it will maintain the appropriate patient and customer support services, as well as product supply, during this transition period. In the EU, Innate will no longer progress Lumoxiti regulatory or commercial activities.
The accounting impacts will be presented in the December 31, 2020 financial statements. As a reminder, the net book value of Lumoxiti intangible assets amounted to €45.2 million, as of June 30, 2020.
All other agreements with AstraZeneca remain unchanged.
About Lumoxiti (moxetumomab pasudotox-tdfk):
Lumoxiti is a CD22-directed immunotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death. Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of r/r HCL. AstraZeneca is the marketing authorization applicant for the EU filing.