Merck Eisai Agreement
Planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in selected solid tumors and a multicenter, open-label, single-arm Phase 1b/2 study evaluating the efficacy and safety of eribulin in combination with pembrolizumab in triple-negative metastatic breast cancer. Eisai and Merck will establish a joint development committee to oversee clinical development activities. Studies are expected to begin in the second half of 2015. Financial terms of the deal were not disclosed. Under the terms of the agreement, Merck will pay Eisai an upfront payment of $300 million and up to $650 million for certain option rights until 2020 (Eisai`s fiscal year: fiscal year ended March 2021) and $450 million as reimbursement for research and development expenses. In addition, Eisai is eligible to receive up to $385 million. Dollars related to the achievement of certain clinical and regulatory milestones and up to a maximum of $3.97 billion for the achievement of milestones related to the sale of LENVIMA. Assuming that all development and business objectives are met for all indications, the total amount of upfront payments, option payments, regulatory payments, and sales milestone payments could reach up to $5.76 billion. Under the terms of the agreement, the companies will collaborate in the joint development and commercialization of the cancer drug LENVIMA. Currently, the company has received approval for the use of the drug in refractory thyroid cancer in more than 50 countries, including the United States, Japan, Europe and Asia. The drug is also used in combination with everolimus for the treatment of patients with renal cell carcinoma (CRC) as well as with Merck`s immunotherapeutic drug KEYTRUDA. For more information about Eisai Co., Ltd., please visit www.eisai.com.
For more information on our oncology clinical trials, see www.merck.com/clinicaltrials. TOKYO and KENILWORTH, N.J. March 8, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, Representative and Chief Executive Officer: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth, N.J., U.S. (NYSE: MRK) (announced as MSD outside the U.S. and Canada) today announced that the companies have entered into a strategic collaboration for the joint global development and commercialization of LENVIMA® (Lenvatinib Mesylate). an orally available tyrosine kinase inhibitor discovered by Eisai. Under the terms of the agreement, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., LENVIMA will jointly develop and commercialize both as monotherapy and in combination with Merck & Co., Inc.`s anti-PD-1 treatment KEYTRUDA® (pembrolizumab), Kenilworth, N.J., USA. Eisai will record sales of LENVIMA products worldwide in monotherapy and combination, as well as Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai will share gross profit equally. LENVIMA is currently approved as monotherapy for the treatment of thyroid cancer, as well as in combination with everolimus, for the treatment of patients with renal cell carcinoma (RCC) in whom previous treatment has failed. Applications for approval of LENVIMA monotherapy for the treatment of hepatocellular carcinoma have been filed in Japan, the United States, Europe, China and other countries.
A Phase 3 study sponsored by Eisai (Study 307) evaluating distinct combinations of LENVIMA with KEYTRUDA (pembrolizumab) or LENVIMA with everolimus versus chemotherapy alone for the treatment of CRC is ongoing. In January 2018, the companies announced that the U.S. Food and Drug Administration (FDA) had granted breakthrough treatment designation for the LENVIMA/KEYTRUDA combination in advanced and/or metastatic RCC. This was based on interim results from an ongoing Phase 1b/2 study (Study 111/KEYNOTE-146) evaluating the combination in selected solid tumors (including CRC and endometrial cancer) that provided evidence of synergistic effects on the observed overall response rate, regardless of treatment experience or PD-L1 tumor expression. Under the terms of the agreement, the companies will also jointly launch new clinical trials evaluating the LENVIMA/KEYTRUDA combination to support 11 potential indications in six cancers (endometrial cancer, non–small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma) as well as a basket study for several cancers. ”In an effort to maximize the potential of LENVIMA and accelerate the development of innovative treatments in the age of cancer evolution, we have entered into this collaboration with Merck, which developed the anti-PD-1 antibody KEYTRUDA,” commented Haruo Naito, Representative and CEO of Eisai Co., Ltd. “By offering new treatment options, including for refractory cancers, without hope of a cure, we are committed to continuing to help increase benefits for patients and their families. “In collaboration with Eisai, we aim to maximize the value of LENVIMA for its current indications while seeking further approvals in combination with KEYTRUDA for a variety of cancers,” said Dr. Roger M. Perlmutter, President of Merck Research Laboratories. “There is strong scientific evidence supporting the synergistic effects of KEYTRUDA in combination with LENVIMA, and the companies have already received breakthrough therapy status from the United States.
FDA for KEYTRUDA/LENVIMA in renal cell carcinoma. Through this collaboration, we will expand our oncology portfolio and have the opportunity to help even more cancer patients around the world. Eisai Co., Ltd. and Merck (NYSE: MRK), announced outside the U.S. and Canada as MSD, today announced that the companies have entered into a strategic collaboration for the joint global development and commercialization of LENVIMA® (lenvatinib mesylate), an oral tyrosine kinase inhibitor discovered by Eisai. Under the terms of the agreement, Eisai and Merck will jointly develop and commercialize LENVIMA, both as monotherapy and in combination with Merck`s anti-PD-1 keytruda® (pembrolizumab) treatment. Today, Merck is a global healthcare leader committed to making the world prosper. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biological therapies and animal health products, we work with our customers and operate in more than 140 countries to provide innovative healthcare solutions. We are also demonstrating our commitment to improving access to health care through broad-based policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube. .