Emcure Pharmaceuticals, a leading integrated global pharmaceutical company from India has announced the launch of the world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC). Emcure will be marketing the drug under brand name ‘Eribilin’, with an aim to offer high-quality and cost-effective treatment option to breast cancer patients in India.

As per reports from the Indian Council of Medical Research & Population Based Cancer Registry (ICMR-PBCR) Breast cancer is the commonest occurring cancer in urban Indian women and the second commonest in rural women. Although world class breast cancer treatment is available in India, majority of the patients are unable to access it due to lack of quality infrastructure, skills and above all financial resources.

“Incidence of breast cancer is on the rise in India and being a price sensitive market with low awareness, with the launch of Eribilin we aim to provide a proven and cost-effective treatment of high quality and efficacy as offered by the innovator brand. It is a proud moment for Emcure to launch Eribilin, the world’s first generic version of the innovator brand that will break the price barrier making it a cost-effective option for patients,” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd

Various Indian studies suggest that about 20% of breast cancers are triple-negative breast cancers. Triple-negative breast cancer (TNBC) is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. It means that the growth of the cancer is not fuelled by the hormones estrogen and progesterone, or by the HER2 protein. Even though chemotherapy may work well for this type of breast cancer, the chance of relapse is high and overall prognosis is poor than the other types of breast cancer.

Emcure’s Eribilin has been approved by DCGI to be marketed in India. “Breast cancer is the most common type of cancer affecting women in India and its incidence is on the rise. Currently available treatment for triple negative breast cancer in India is out of reach of most patients due to its high cost. Emcure’s Eribilin will change this scenario by offering a world-class, high quality drug at a reasonable price to the patients in India” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd.

Eribulin is a non-taxane inhibitor of microtubule dynamics and remains effective in MBC previously treated with an anthracycline and a taxane. Eribulin is a complex API derived from a marine natural product called Halocondrin B. “Emcure’s R&D resources are equipped with technical competence and state-of-the-art development facility to develop such complex generics. Generic Eribulin is a landmark achievement of Emcure’s R&D efforts both in API manufacturing and formulation,” said Dr. Mukund Gurjar, Chief Scientific Officer, Emcure Pharmaceuticals.

Emcure will manufacture generic Eribulin at its state of the art plant at Hinjewadi in Pune and market it at a cost which will be approximately 40% less than the innovator brand bringing hope to millions of breast cancer patients in India. The drug would currently be marketed in India, however Emcure plans to register the brand in international markets as well, wherever the drug is about to go off-patent.

Eribilin is world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC). Eribulin is a mechanistically unique inhibitor of microtubule dynamics and binds predominantly to a small number of high affinity sites through both cytotoxic and non-cytotoxic mechanisms. It eliminates cancer cells through prolonged and irreversible mitotic blockade. The parent molecule is a potent, naturally occurring mitotic inhibitor found in the sponge genus Halichondria.

ERIBILIN has been developed indigenously by Emcure Pharmaceuticals and offers the same quality and efficacy as the original brand. ERIBILIN will be manufactured in Emcure’s plant at Hinjewadi, Pune.

Emcure Pharmaceuticals Ltd. is a leading vertically integrated global pharmaceutical company from India focusing on R&D, marketing and manufacturing of acute and chronic therapy range of products. It is ranked among the top 10 pharmaceutical companies in India and is the leading provider of oncology, nephrology, antiretroviral, gynaecology, cardiac, anti-malarial and anti-infective therapies. Globally it is present in 70 countries with 15 subsidiaries and 7 representative offices. Its range of products for the treatment of breast cancer includes Taxotere (docetaxel), Palcitaxel, Fulvestrant, Letrozole and Lapatinib.