--Must See--

Bioinformatics Summer Internship 2024 With Hands-On-Training + Project / Dissertation - 30 Days, 3 Months & 6 Months Duration

align: center;">Merck, Japan’s Eisai Ink Up-to-$5.76B Cancer Collaboration Deal

The drugmaker has now teamed up with another pharma heavyweight, Eisai, for the worldwide co-development and co-commercialization of LENVIMA (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai. Under the agreement, Eisai and Merck will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

Subject to sales, the alliance could be worth as much as $5.76 billion for the Japanese firm.

The terms of the partnership dictate that Eisai will provide an upfront payment of $300 million, a payment of $450 million in reimbursement for research and development costs, and up to $850 million for certain options rights through to the end of the company’s financial year in March 2021; the Japanese drugmaker said it forecasts that Lenvima could bring in annual sales of more than $1 billion by this time.

A Phase 3 study (Study 307), sponsored by Eisai, is ongoing to evaluate separate combinations of LENVIMA with KEYTRUDA (pembrolizumab) or LENVIMA with everolimus versus chemotherapy alone for the treatment of RCC. In January 2018, the companies announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the LENVIMA/KEYTRUDA combination in advanced and/or metastatic RCC. This was based on interim results from an ongoing Phase 1b/2 trial (Study 111/KEYNOTE-146), evaluating the combination in select solid tumors (including RCC and endometrial cancer), which provided evidence for synergistic effects on the observed overall response rate, regardless of treatment experience or PD-L1 tumor expression.

Per the agreement, the companies will also jointly initiate new clinical studies evaluating the LENVIMA/KEYTRUDA combination to support 11 potential indications in six types of cancer (endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma), as well as a basket trial targeting multiple cancer types.

Together with Eisai, we aim to maximize the value of LENVIMA for its current indications while jointly pursuing additional approvals in combination with KEYTRUDA across a wide range of cancers,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “There is strong scientific evidence supporting synergistic effects of KEYTRUDA when used in combination with LENVIMA, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the KEYTRUDA/LENVIMA combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”

Aiming to maximize the potential of Lenvima and expedite the creation of innovative treatments in this age of ‘Cancer Evolution,’ we have entered into this collaboration with Merck who developed the anti-PD-1 antibody Keytruda,” said Haruo Naito, Eisai’s representative corporate officer and chief executive officer, in a statement. “By providing new treatment options including for refractory cancers with no hopes for a cure to date, we are striving to further contribute to increasing the benefits provided to patients and their families.

In search of the perfect burger. Serial eater. In her spare time, practises her "Vader Voice". Passionate about dance. Real Weird.