ºÚÁÏÍø

ºÚÁÏÍø., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “ºÚÁÏÍø”) announced today that its pharmaceutical sales subsidiary in Mexico, ºÚÁÏÍø Laboratorios S. de R.L. de C.V. (Location: Mexico City, “ºÚÁÏÍø Mexico”) has launched the anticancer agents Halaven® (eribulin mesylate) and Gliadel® (carmustine implant) in Mexico. These are the first products to be exclusively marketed by the ºÚÁÏÍø Group in Mexico.

Halaven is an anticancer agent discovered and developed by ºÚÁÏÍø. It is currently approved for the treatment of breast cancer in approximately 60 countries worldwide including Japan, the United States, and in Europe. Halaven was approved in Mexico in August 2014 for third-line treatment for locally advanced or metastatic breast cancer, subsequent to treatment with at least two chemotherapy regimens including an anthracycline and a taxane, and since then ºÚÁÏÍø has been working on preparations for the launch of the product.

Gliadel is a sustained-release formulation approved for intracranial implantation. Each wafer contains carmustine, a nitrosourea alkylating agent, distributed in a biodegradable copolymer matrix. Gliadel was approved in Mexico in November 2014 as an orphan drug for the treatment of patients with newly diagnosed high-grade malignant glioma (brain cancer) as an adjunct to surgery and radiation, as well as for the treatment of patients with recurrent glioblastoma multiforme as an adjunct to surgery.

In 2013, Mexico's pharmaceutical market was worth 13.5 billion U.S. dollars (approximately 1.6 trillion yen), making it the 13th biggest pharmaceutical market in the world, and the 2nd biggest in Latin America after Brazil¹. ºÚÁÏÍø Mexico was established in August 2011, and has since been working to complete product registration procedures. In addition to these newly launched anticancer products, ºÚÁÏÍø Mexico has submitted the antiepileptic agents Inovelon® and Fycompa®, the anticancer agent Targretin® as well as the antiobesity agent BELVIQ® for regulatory review. Meanwhile, ºÚÁÏÍø established its first pharmaceutical sales subsidiary in Latin America in Brazil in April 2011, and commenced sales of Halaven in the country in November 2014.

ºÚÁÏÍø is committed to delivering innovative new treatments to patients in Mexico while enhancing its product lineup and marketing framework as it seeks to further increase the benefits it provides to patients and their families in the region.

The Mexican health insurance system is built upon two main pillars, a public health insurance system and a national health insurance program. The public health insurance system consists of the Instituto Mexicano del Seguro Social (IMSS) which is social insurance for employees of private companies, and the Instituto de Seguridad y Servicios de los Trabajadores del Estado (ISSSTE) which is for employees of the public sector. Approximately half of the national population is covered by this system. The majority of people who are not enrolled in the public health insurance system and tend to have lower incomes are covered by a national health insurance program which is funded by the federal and state governments.

ºÚÁÏÍø has positioned the five countries/regions of Russia, Brazil, Mexico, Canada and Australia as strategic markets, and is steadily working on approval submission and launch of global brands Halaven, Fycompa and Lenvima as well as the establishment and expansion of business infrastructure in these countries. Among these strategic markets, ºÚÁÏÍø positions Brazil and Mexico, which are the core drivers of the expected future growth in Latin America, as the most important.
Preceding the launch of Halaven and Gliadel in Mexico, ºÚÁÏÍø launched Halaven in November 2014 in Brazil as the company's first product launched in Latin America. Currently in Brazil, ºÚÁÏÍø has submitted the antiepileptic drugs Fycompa and Inovelon, the obesity treatment BELVIQ as well as the anticancer agents Gliadel and Lenvima for regulatory review.