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Karyopharm and Menarini Group Enter into Exclusive License Agreement to Commercialize NEXPOVIO® (selinexor) in Europe and Other Key Global Territories

Thursday, December 23, 2021

Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group, ("Menarini"), a privately-held, leading international pharmaceutical company, today announced their entry into an exclusive licensing agreement whereby Menarini will commercialize NEXPOVIO, Karyopharm's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in Europe and other key global territories.

Under the terms of the agreement, Menarini received exclusive rights to commercialize NEXPOVIO for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. In exchange, Karyopharm will receive an upfront payment of $75 million (USD) in 2021 and is eligible to receive up to an additional $202.5 million in future milestones, plus tiered double-digit royalties on net sales of NEXPOVIO in the licensed territories.

"Menarini is a global pharmaceutical company, with a strong heritage and footprint in Europe and an unwavering commitment to patients, that is dedicated to innovation and bringing new treatment options in oncology. Menarini is an ideal partner to maximize selinexor's potential to have a positive impact on the treatment of cancer in Europe, Latin America and other key countries and this transaction marks an important step forward toward that goal," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "With a shared vision on the potential of selinexor and Menarini's commercialization expertise, this agreement aligns our two companies with the common goal of expanding the number of patients who can access NEXPOVIO in these important global territories."

"We are delighted to partner with Karyopharm to provide NEXPOVIO in Europe, Latin America and other key countries in the world," said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "Patients suffering from multiple myeloma continuously need different options as resistance develops to first line therapies and the unique mechanism of action of selinexor makes it an ideal partner as a backbone therapy in second line and beyond. The potential further expansion of NEXPOVIO in solid tumors, such as in endometrial cancers, where limited options exist, underline the wide potential of selinexor in playing a role in cancer treatments aligning well with our mission of providing therapies that can prolong patient lives."     

NEXPOVIO has received conditional marketing authorization from the European Commission in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for NEXPOVIO in combination with Velcade® (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission regarding the potential approval for the expanded indication. This review is expected to be completed during the first half of 2022.

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