• Acquisition of Stemline estab­lishes Menarini’s presence in the U.S. bio­pharma­ceu­tical on­col­ogy mar­ket
• Menarini will sup­port fur­ther de­vel­op­ment of Stemline’s ELZONRIS® and enable global ex­pan­sion by leveraging its com­mer­cial infrastructure in Europe and other ex-U.S. geographies
• Following the trans­action, Menarini will con­tinue to re­search ELZONRIS in addi­tional CD123-expressing in­di­ca­tions

Florence, Italy (Press Release) – Menarini Group, a privately held Italian pharma­ceu­tical and diagnostics com­pany, to­day an­nounced that is has suc­cess­fully com­pleted the ac­qui­si­tion of Stemline Thera­peutics Inc., a com­mer­cial-stage bio­pharma­ceu­tical com­pany focused on the de­vel­op­ment and com­mer­cial­i­za­tion of novel on­col­ogy thera­peutics (Nasdaq: STML), for an aggregate cash con­sid­er­a­tion up to $677 million on a fully diluted basis.

The trans­action, which was an­nounced on 4 May 2020, strengthens Menarini’s on­col­ogy port­folio with the addi­tion of both com­mer­cial and clin­i­cal-stage assets. Menarini acquired Stemline for an up­front pay­ment of $11.50 per share in cash and one non-tradeable Con­tin­gent Value Right (CVR) that will entitle each holder to an addi­tional $1.00 per share in cash upon com­ple­tion of the first sale of ELZONRIS in any EU5 country after Euro­pean Com­mis­sion ap­prov­al.

Stemline launched ELZONRIS for the treat­ment of blastic plas­ma­cytoid dendritic cell neoplasm (BPDCN) in adult and pedi­atric patients, two years or older, fol­low­ing the ap­prov­al by the United States Food and Drug Admin­istra­tion in De­cem­ber 2018. ELZONRIS is a novel targeted ther­apy directed to the interleukin-3 (IL-3) re­cep­tor-α (CD123), a target present on a wide range of malig­nan­cies. In parallel, Stemline has been eval­u­ating ELZONRIS in clin­i­cal trials in addi­tional in­di­ca­tions in­clud­ing chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others. Stemline’s addi­tional pipe­line can­di­dates in­clude felezonexor (SL-801) (XPO1 in­hib­i­tor; Phase 1 in ad­vanced solid tumor patients on­go­ing) and SL-1001 (RET kinase in­hib­i­tor, IND-enabling stud­ies on­go­ing).

Elcin Barker Ergun, CEO of Menarini Group, commented, “We are very ex­cited to com­plete the ac­qui­si­tion of Stemline and to welcome their accomplished team to Menarini. The addi­tion of ELZONRIS, which has poten­tial to treat many other malig­nan­cies, as well as the other attractive pipe­line assets augments our re­search and de­vel­op­ment capabilities and will ac­cel­er­ate our efforts to de­liver novel on­col­ogy thera­peutics to patients in need.”

About ELZONRIS®

ELZONRIS® (tagraxofusp), a targeted ther­apy directed to CD123, is approved by the U.S. Food and Drug Admin­istra­tion (FDA) and com­mer­cially avail­able in the U.S. for the treat­ment of adult and pedi­atric patients, two years or older, with BPDCN. For full pre­scrib­ing in­for­ma­tion in the U.S., visit www.ELZONRIS.com. In Europe, a mar­ket­ing authori­za­tion appli­ca­tion (MAA) is under review by the Euro­pean Medicines Agency (EMA).

ELZONRIS is also being eval­u­ated in addi­tional clin­i­cal trials in other CD123+ in­di­ca­tions, in­clud­ing chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others are planned in­clud­ing a CD123+ all-comers trial.

About CD123

CD123 is a cell surface target ex­pressed on a wide range of malig­nan­cies in­clud­ing blastic plas­ma­cytoid dendritic cell neoplasm (BPDCN), cer­tain myeloproliferative neoplasms (MPNs) in­clud­ing chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and poten­tially enriched in cer­tain AML subsets), myelo­dys­plastic syn­drome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on mul­ti­ple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lym­phoma (HL), and cer­tain Non-Hodgkin’s lym­phomas (NHL). In addi­tion, CD123+ cells have been detected in the tumor microenvironment of sev­er­al solid tumors as well as in cer­tain auto­immune disorders in­clud­ing cu­tane­ous lupus and scleroderma.

About BPDCN

BPDCN, formerly blastic NK-cell lym­phoma, is an aggressive hema­to­logic malig­nan­cy, often with cu­tane­ous mani­fest­a­tions, with historically poor out­comes. BPDCN typ­i­cally presents in the bone mar­row and/or skin and may also in­volve lymph nodes and viscera. The BPDCN cell of origin is the plas­ma­cytoid dendritic cell (pDC) precursor. The diag­nosis of BPDCN is based on the immuno­phe­no­typic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Or­ga­ni­za­tion (WHO) termed this dis­ease “BPDCN” in 2008; pre­vi­ous names in­cluded blastic NK cell lym­phoma and agranular CD4+/CD56+ hematodermic neoplasm. For more in­for­ma­tion, please visit the BPDCN dis­ease awareness website at www.bpdcninfo.com.

About Menarini

The Menarini Group is a lead­ing inter­na­tional pharma­ceu­tical com­pany with a presence in over 100 countries, in­clud­ing a direct presence in over 70 countries. Its global plat­form extends throughout Europe, Central America, Africa, the Middle East and Asia and gen­er­ates over $4.2 billion in annual sales. For over 125 years, Menarini has been investing in the de­vel­op­ment and dis­tri­bu­tion of pharma­ceu­ticals to serve patients and physicians around the world with a full port­folio of prod­ucts in the cardiovascular, gastroenterology, metabolic, infectious dis­eases and anti-in­flam­ma­tory / analgesic thera­peutic areas. Menarini is also com­mit­ted to on­col­ogy, with sev­er­al new inves­ti­ga­tional drugs in de­vel­op­ment for the treat­ment of a variety of tumors.

Source: The Menarini Group.