The huge opportunities offered by the Japanese healthcare sector is a big attraction for global pharma majors. The Japanese government last July announced a strategy to support the creation of new medical-related markets by 2020 in such areas as innovative medical device development, medicine and healthcare. The initiative is designed to boost the value of life sciences to more than 50 trillion yen (€515 billion) and create more than 2.84 million jobs.

Roughly half of the growth (€206 billion) was expected to come from outside the country. To this end, the government is encouraging Japanese companies to capture market share in overseas healthcare sectors within the next eight years.

Domestically, the government anticipates that the creation of innovative medical devices and drugs will help boost the nation’s economy by €17.5 billion. It also aims to build up its healthcare market to a value of €257 billion and add 800,000 employees in that sector.

Many of the global multinationals have strong presence in Japan and are keen on entering into tie-ups with Japanese companies as well as launching their products in the Japanese market.

The US based Sigma-Aldrich, a leading life science and high technology company, has a strong presence in Japan. In an earlier interview with Pharmabiz,Vice President & Managing Director, International Eric Green had pointed out that Sigma Aldrich has a strong presence in Japan with manufacturing capabilities in Sapporo, distribution and logistics facility in Tokyo, and sales and administration offices in Tokyo and Osaka.

" Japan is an important region that drives innovation and new technologies in the areas of life science and high technology, therefore, we will continue to invest in capabilities to expand our products and services to support our customers", he added.

ReSearch Pharmaceutical Services Inc. (RPS), a leading global contract research organization (CRO), and Asklep Inc. (Asklep), one of Japan's largest CROs, have created a Joint Venture Company (JVC) to deliver leading-edge R&D outsourcing solutions in Japan to the biopharmaceutical and medical device industries.

The exclusive RPS-Asklep collaboration will leverage RPS' proprietary structures and global footprint to deliver customized solutions across large, mid-size and small and virtual organizations. A breadth of options ranging from embedded, hybrid, and full-service solutions will be available to clients using best-in-class standard operating procedures, processes and systems. Alan Morgan , RPS' chief operating officer, will assume the role of chief executive officer (CEO) of the JVC, in addition to his current responsibilities.

Commenting upon the announcement Daniel Perlman , CEO and founder of RPS said, "By combining RPS' innovative approaches to meeting the industry's needs with Asklep's excellent reputation, significant size, and local infrastructure, RPS will be positioned to meet current and future needs across the biopharmaceutical and medical device industries. Japan is an important market for clinical development and this JVC brings ownership and accountability with mutual success and long-term stability to the benefit of customers."

The US- based Edison Pharmaceuticals, a specialty pharmaceutical company dedicated to developing treatments for children and adults with orphan mitochondrial diseases has entered into a research and development (R&D) and commercialisation agreement with Dainippon Sumitomo Pharma Co., Ltd. (DSP) for the development of EPI - 743 and EPI - 589 in Japan. Under the terms of the agreement, DSP will gain development and commercialisation rights in Japan in exchange for Edison receiving $35 million in upfront and $15 million in R&D support.

In addition, Edison will be eligible to receive $10 - 35 million in development milestones per indication and up to $460 million in commercial milestone payments as well as royalties on commercial sales.

The initial scope of the transaction includes both paediatric orphan inherited mitochondrial and adult central nervous system diseases. Under the terms of the agreement, DSP will undertake activities required for development, approval and commercialization of EPI - 743 in Japan. The work will initially focus on orphan paediatric mitochondrial disease. Edison will retain 100 per cent ownership and direct all research, clinical, and commercial development of EPI - 743 and EPI - 589 outside of Japan.

In addition, the parties will collaborate on the research and development of EPI - 589 with a focus on adult central nervous system disease. This collaboration is based on the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurologic disorders.

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved American multinational Pfizer's Xeljanz (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. Xeljanz may be used in patients in whom clinical symptoms due to the disease remain even after appropriate treatment with at least one other disease-modifying antirheumatic drug (DMARD), such as methotrexate. The recommended dose of Xeljanz is 5 mg twice daily.

Xeljanz will be commercially available in Japan after the National Health Insurance listing and will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Pfizer and Takeda also currently co-promote the RA drug Enbrel (etanercept) in Japan.

Xeljanz is the first approved oral treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. Initially, Xeljanz will be made available in Japan to medical institutions participating in an all-patient surveillance programme.

The approval of Xeljanz in Japan is supported by a multi-study, global clinical development programme, which evaluated Xeljanz in approximately 5,000 patients across various RA patient populations. The application also included data from Japanese subjects from two phase 2 studies, one phase 3 study and an ongoing long-term extension study. Across five global pivotal trials, Xeljanz 5 mg twice daily demonstrated efficacy, whether administered alone or in combination with a non-biologic DMARD, such as methotrexate, in patients who had a previous inadequate response to non-biologic or biologic DMARDs, including tumour necrosis factor (TNF) inhibitors.

Bayer HealthCare, a subgroup of Bayer AG recently received the Japan Ministry of Health, Labour and Welfare (MHLW) approval for Stivarga (regorafenib) tablets for the treatment of patients with unresectable, advanced/recurrent colorectal cancer (CRC). Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumour growth and progression – angiogenesis, oncogenesis and maintenance of the tumour microenvironment.

The approval of Stivarga by the MHLW is based on results from the pivotal phase III CORRECT study that demonstrated a statistically significant improvement in overall survival and progression-free survival compared to placebo in patients with metastatic CRC (mCRC) whose disease had progressed after approved standard therapies.

The international multi-centre phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC, whose disease has progressed after approved standard therapies.

The CORRECT study also included 20 sites in Japan. The study results showed that regorafenib plus BSC significantly improved both overall survival and progression-free survival (PFS) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. The data also showed a survival benefit (OS and PFS) in the regorafenib arm across nearly all subgroups analyzed. In the study, median OS was 196 days with regorafenib versus 151 days with placebo; median PFS was 59 days with regorafenib versus 52 days with placebo.