Italian pharmaceutical and diagnostics firm Menarini has agreed to acquire Stemline Therapeutics, a commercial-stage biopharmaceutical company, in a transaction valued up to $677m.

Engaged in the development and commercialisation of novel oncology therapeutics, Stemline has launched ELZONRIS (tagraxofusp), an FDA-approved and commercially available targeted therapy to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and paediatric patients.

Stemline chairman CEO and founder Ivan Bergstein said: “Joining Menarini represents a unique opportunity for Stemline to advance the commercialisation of ELZONRIS across the globe and to accelerate the development of our pipeline of oncology assets.

“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.

“We are excited to be combining with a like-minded organisation in Menarini, in a transaction that will deliver immediate and significant cash value to our shareholders, while also allowing our shareholders to participate in the future upside of ELZONRIS’s European launch.”

ELZONRIS is an FDA approved therapy for treating BPDCN in adult and paediatric patients

ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123), approved by the US Food and Drug Administration in December 2018, and currently under review by the European Medicines Agency (EMA).

The drug is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukaemia (CMML), myelofibrosis (MF), acute myeloid leukaemia (AML), and additional trials and indications are planned.

Stemline is expected to develop additional applications of ELZONRIS to serve the unmet needs of patients suffering from difficult to treat diseases and cancers, by leveraging the support of Menarini’s infrastructure.

Also, the company would benefit from Menarini’s experience in commercialising products in European and emerging markets and intends to launch after receipt of regulatory approval in ex-US territories.

Menarini Group CEO Elcin Barker Ergun said: “Stemline is an excellent fit for Menarini, enabling us to expand our presence in the U.S. with an established biopharmaceutical company focused on developing oncology therapeutics.

“Through this acquisition, we will continue to strengthen our portfolio and pipeline of oncology assets and deliver novel therapies around the world. We look forward to uniting together with the Stemline team to advance our shared mission of serving patients.”