Eisai and MSD Japan Commence Collaboration on Commercialization Activities for LENVIMA (Lenvatinib) in Japan

Product name:Eisai and MSD Japan Commence

2018/10/23 update

Industry:BioTech

TOKYO, Oct 22, 2018 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that the two companies have commenced joint medical and marketing activities for tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate) in Japan.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co- development and co-commercialization of LENVIMA. Co-commercialization activities between Eisai, who has extensive real-world evidence for LENVIMA, and Merck & Co., Inc., Kenilworth, N.J., U.S.A., who has a strong commercial footprint and medical expertise that spans the globe, are in progress sequentially around the world, and commenced in the United States in June 2018. In Japan, Eisai and MSD will jointly work on medical activities such as the activities of Medical Science Liaisons (MSL), and provide information through the internet utilizing digital content. Meanwhile, information provision via Medical Representatives (MR) is scheduled to commence in January 2019, and collaboration on a call center for medicines between Eisai and MSD will commence in January or later.

Currently, LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a second- line treatment for renal cell carcinoma (RCC) in over 45 countries including the United States and in Europe. In addition, LENVIMA has been approved as a treatment for hepatocellular carcinoma (HCC) in Japan, the United States, Europe, China and other countries. In Japan, approximately 4,500 HCC patients have been treated with LENVIMA since approval of the HCC indication in March 2018.

Eisai and MSD are striving to collaborate on providing information on LENVIMA in Japan starting with the HCC indication, and, will work to expedite the maximization of LENVIMA's contribution to patients with the hope to expand co-commercialization activities for potential future indications in Japan.

About Lenvima (lenvatinib mesylate)

Discovered and developed in-house by Eisai, LENVIMA is an orally administered kinase inhibitor with a novel binding mode that selectively inhibits the multi activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRalpha; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.

Currently, Eisai has obtained approval for LENVIMA as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a second-line treatment for RCC in over 45 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for RCC.

In addition, LENVIMA has been approved as a treatment for HCC in Japan, the United States, Europe, China and other countires. Eisai has submitted applications for an indication covering hepatocellular carcinoma in Taiwan (December 2017) as well as in other countries.

About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD in the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s anti-PD-1 therapy KEYTRUDA (pembrolizumab). In addition to ongoing clinical studies of the combination, the companies will jointly initiate new clinical studies evaluating the LENVIMA and KEYTRUDA combination to support 11 potential indications in six types of cancer (bladder cancer, endometrial cancer, head and neck cancer, HCC, melanoma and non-small cell lung cancer), as well as a basket trial targeting six additional cancer types. The LENVIMA and KEYTRUDA combination is not approved in any cancer types today.

About MSD

For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. MSD is a trade name of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies,

programs and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit www.msd.co.jp and connect with us on Facebook, Twitter and YouTube.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our human health care philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Communication Department
MSD K.K.
TEL: +81-(0)3-6272-1001

Public Relations Department
Eisai Co., Ltd.
TEL: +81-(0)3-3817-5120
Copyright 2018 JCN Newswire. All rights reserved. www.jcnnewswire.com

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