EISAI INDIA AND MYLAN ENTER INTO CO-EXCLUSIVE MARKETING AGREEMENT TO COMMERCILIZE TECERIS

[Vishakhapatnam, Bengaluru – India, September 2019] — Eisai Pharmaceuticals India Pvt. Ltd (a subsidiary company of Eisai Co., Ltd., Headquarters: Tokyo, CEO: Haruo Naito, “Eisai India”) and Mylan Pharmaceuticals Pvt Ltd. (Mylan), today 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 eribulin for 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 brand Halaven® 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 hhc 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 medicine through our co-exclusive marketing relationship as both Eisai India and Mylan share 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.1

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.

Media Inquiries:

Shubhangi Naik
Sr GM & Head – Legal & Compliance
Eisai Pharmaceuticals India Pvt. Ltd
Email: s-naik@eisai.co.in
Phone: +91 22 40751311

Ritika Verma
Head of Communications – India & Emerging Markets
Mylan Laboratories Ltd.
Email: ritika.verma@mylan.com
Phone: 91.40.3086 6419

[Notes to editors]

1. About eribulin mesylate (product name: Halaven, “eribulin”)

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 halichondria okadai. 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,3 and 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.

Specifically, eribulin is approved for the following indications.

In the United States for the treatment of patients with:

Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

In Japan for the treatment of patients with:
Inoperable or recurrent breast cancer
Soft tissue sarcoma

In Europe for the treatment of adult patients with:

Locally advanced or metastatic breast cancer who have received a prior anthracycline-containing regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

Unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

2. About Eisai group

Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. 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 (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.

For more information about Eisai, please visit www.eisai.com (for global), www.eisai.co.in (for India), and connect with us on Twitter (global).

3. About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.International Agency for Research on Cancer (http://globocan.iarc.fr/)

1International Agency for Research on Cancer (http://globocan.iarc.fr/)

2. Funahashi Y et al., Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci., 2014; 105, 1334-1342

3. Yoshida T et al., Eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (EMT) to mesenchymal-epithelial transition (MET) states. Br J Cancer, 2014; 110, 1497-1505

Author: ADmiNIstRAtoR