BioPharma

Italy’s Menarini Group to acquire Stemline Therapeutics for $677M

New York-based Stemline won Food and Drug Administration approval in December 2018 for Elzonris, a drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN, an extremely rare but aggressive form of leukemia.

An Italian pharmaceutical and diagnostics company plans to acquire a New York-based firm with a drug used to treat a rare blood cancer.

Florence, Italy-based Menarini Group said Monday that it would spend up to $677 million to buy Stemline Therapeutics, a biotech company based in New York.

Shares of Stemline were up 153.7% on the Nasdaq by late morning following the news. Menarini is a privately held company.

Stemline won Food and Drug Administration approval in December 2018 for Elzonris (tagraxofusp-erzs), a drug used to treat blastic plasmacytoid dendritic cell neoplasm, or BPDCN, in patients aged 2 and older. BPDCN is a rare and aggressive bone marrow cancer that accounts for less than 1% of all acute leukemias. The standard of care for the disease was previously intensive chemotherapy followed by stem cell transplant, though many patients were unable to tolerate that therapy.

“Joining Menarini represents a unique opportunity for Stemline to advance the commercialization of Elzonris across the globe and to accelerate the development of our pipeline of oncology assets,” Stemline CEO Ivan Bergstein said in a statement. “We have transitioned Stemline over the last several years into an established commercial-stage operation with a novel treatment, a growing pipeline and a strong foundation.”

Elzonris targets a cell-surface protein known as CD123, which is expressed in BPDCN as well as other blood cancers like acute myeloid leukemia (AML), chronic myeloid leukemia, B-cell acute lymphoblastic leukemia, Hodgkin’s lymphoma, some non-Hodgkin’s lymphomas, hairy cell leukemia, myelodysplastic syndrome and some myeloproliferative disorders (MPNs). The ClinicalTrials.gov database lists other studies in BPDCN that are recruiting or not yet open for enrollment, along with a study in chronic myelomonocytic leukemia and myelofibrosis and completed studies in AML and multiple myeloma.

Other drugs in Stemline’s pipeline include SL-701, which targets IL-13Ra2, EphA2 and survivin and is in Phase II development for the brain cancer glioblastoma; and SL-801, a small molecule that targets XPO1 and is in a Phase I clinical trial in patients with solid tumors.

Karyopharm Therapeutics’ Xpovio (selinexor) also targets XPO1 and has Food and Drug Administration approval for multiple myeloma.

Photo: designer491, Getty Images

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