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Merck Enters Collaboration and Option to License Agreement with Nerviano Medical Sciences to Develop Next-Generation PARP1 Selective Inhibitor

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Merck, a leading science and technology company, today announceda collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. (NMS) for the next-generation highly selective and brain-penetrant PARP1 (poly (ADP-ribose) polymerase) inhibitor, NMS-293. NMS-293 has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy (Antibody-Drug Conjugates) or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma.

“Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile,” said Victoria Zazulina, M.D., Head of Development Unit Oncology for the Healthcare business of Merck. “The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients.”

PARP is key in the repair of DNA damage, and PARP inhibitors have been shown to be highly efficacious in the treatment of patients with tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers with BRCA-mutations.

Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to $65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

During the option period, NMS and Merck will collaborate on the clinical development of NMS-293, with NMS designing, sponsoring, conducting, and funding global clinical trials.

About NMS-293

NMS-293is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

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About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

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