Eisai Pharma, Mylan sign agreement commercialize metastatic breast cancer drug TECERIS in India

New Delhi- Eisai Pharmaceuticals India Pvt. Ltd and Mylan Pharmaceuticals Pvt Ltd. (Mylan), jointly announced that they have entered into a marketing license agreement to commercialize TECERIS®, the Innovator’s second brand of the anticancer agent Eribulin mesylate (eribulin) in India.

TECERIS® will be manufactured and supplied by Eisai India and marketed by Mylan.This agreement is an important strategy for expanding the access of eribulinfor the treatment of metastatic breast cancer (MBC) patients in India.

Eribulin, a novel anticancer agent, discovered in-house by Eisai was approved in India in April 2013 for the treatment of locally advanced or metastatic breast cancer which previously was being treated with at least two chemotherapy regimens including an anthracycline and a taxane.In October 2013, Eisai India launched the eribulin brandHalaven®for eligible patients under its patient assistance programme.

Commenting on the co-exclusive, marketing relationship, Dr.Sanjit Singh Lamba, Managing Director, Eisai India said, “Our endeavor at Eisai group always has been to ensure that we make our innovative products more accessible to patients who have an unmet medical need. We have been doing it through our tiered pricing programs and now we have entered into a partnership with Mylan to address unmet medical needs. This step is a part of our philosophy of human health care thereby keeping the patient at the center and ensuring our medicines are accessible and affordable.”

Commenting on the partnership, Mr. Rakesh Bamzai, President, India and Emerging Markets, Mylan said, “The launch of the innovator’s second brand of Eribulin, TECERIS® will enable enhanced access to the medicinethrough ourco-exclusive marketing relationship as both Eisai India and Mylanshare a commitment to bring affordable and high-quality medicines to market, especially in areas of unmet need. Eribulin is an important addition to our growing oncology portfolio and, expands the available treatment options for women with advanced or metastatic stages of breast cancer.The collaboration with Eisai India is yet another positive step in our ongoing efforts to help improve affordability and access to essential oncology treatments in India and serve the patient community.”

The number of women diagnosed with breast cancer in India has increased in the recent years, with an estimated 163,000 new cases of breast cancer and approximately 87,000 related deaths in 2018.1 Breast cancer is now the most frequently diagnosed cancer in Indian women.

Eisai group positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. In addition, Eisai group will continue to adopt proactive measures aimed at increasing access to its innovative pharmaceutical products in emerging countries and the developing world in order to contribute to an increase in the benefits provided to local patients and their families.

The partnership between Eisai India and Mylan will lead to enhanced access and affordability of cancer treatment for breast cancer patients in India. Mylan’s oncology portfolio in India includes high quality, affordable cancer-related cytotoxic and targeted therapies forbreast, lung and colorectal cancer.

Eribulin is in the halicondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally, Eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge halichondriaokadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, non-clinical studies showed Eribulin’s unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores,2 promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate,3and etc.

Eribulin was first approved as a treatment in the United States in November 2010 for patients with metastatic breast cancer. Eribulin is currently approved for use in the treatment of breast cancer in over 65 countries worldwide, including Japan and countries in Europe, the Americas and Asia. Furthermore, eribulin was first approved as a treatment for soft tissue sarcoma in the United States in January 2016 and is approved in over 60 countries including Japan and in Europe and Asia. Furthermore, eribulin has been designated as an orphan drug for soft tissue sarcoma in the United States and Japan.