Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe

• Exclusive agreement covers 13 Central and Eastern European markets
• Collaboration will help expand access to VANFLYTA for patients with newly diagnosed FLT3-ITD positive AML

MUNICH--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and GENESIS Pharma have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA^® (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).

Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed.

VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, based on the results from the QuANTUM-First trial.

“This agreement with GENESIS Pharma represents an important step in our ambition to expand access to our innovative targeted medicine across Central and Eastern Europe,” said Markus Kosch, MD, Head, Oncology Business Division Europe and Canada, Daiichi Sankyo. “By combining our scientific expertise with the strong regional footprint of GENESIS Pharma, we aim to accelerate access to VANFLYTA for patients with newly-diagnosed FLT3-ITD positive AML and ultimately help improve outcomes in this high-risk population.”

“This new strategic collaboration marks another significant milestone for our company, reinforcing our long-standing expertise and focus on advancing medicines for difficult-to-treat cancers,” said Constantinos Evripides, Managing Director, GENESIS Pharma. “Daiichi Sankyo has entrusted us with a broad territory across Central and Eastern Europe and we look forward to working together to accelerate access to VANFLYTA across the region.”

About FLT3-ITD Positive Acute Myeloid Leukemia

Almost 487,300 new cases of leukemia were reported globally in 2022, with more than 305,400 deaths.¹ AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.^2,3 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.^4,5 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.⁶ Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.^7,8 FLT3-ITD mutations occur in about 25-30% of all adult patients suffering from AML.^7,8

About VANFLYTA

VANFLYTA is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries/regions in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive based on the results from the QuANTUM-First trial. In the U.S., VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

In Japan, VANFLYTA is also approved for the treatment of patients with relapsed/refractory AML that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.eu.

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com and follow us on LinkedIn.

References:

^1 Global Cancer Observatory. Population Fact Sheet: World. Updated February 2024.

^2 American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023

^3 Dong Y, et al. Exp Hematol Oncol. (2020);9:14.

^4 Rodriguez-Abreu D, et al. Ann Oncol. (2007);18 Suppl 1:i3-i8

^5 Heuser M, et al. Ann Oncol. (2020) 31(6):697-712.

^6 Kennedy VE, et al. Front Onc. 23 December 2020;10. Volume 10 – 2020

^7 Daver N, et al. Leukemia. (2019) 33:299-312.

^8 Patel JP, et al N Engl J Med. (2012) Mar 22;366(12):1079-89.