Astellas Pharma, a global pharmaceutical company headquartered in Tokyo and driven by a strong commitment to research and development (R&D), exhibits special dedication to its business philosophy. It lives and breathes its mission of improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The company was born out of a merger in 2005 between two Japanese pharmaceutical companies - Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical. It was an integration that combined more than two centuries of pharmaceutical expertise and history. Since the merger, Astellas has led important breakthroughs in the medical field by combining its high R&D capabilities with its true passion for patients. Throughout this, the key word has been "innovation". "Innovation is the source of our growth," says Yoshihiko Hatanaka, president and CEO of Astellas. "By predicting future environmental changes and using our high R&D competencies, we have dedicated our efforts to innovative high value-added drug discovery. We've made steady progress globally by accelerating the development of pipeline medicines and continuously introducing innovative products to the market." Innovation's role in business operations Astellas commits itself to proprietary ethical pharmaceutical business. In particular, the company focuses on innovative drug discovery in areas where unmet medical needs exist and where growth can be expected through innovation. Generic drugs or over-the-counter, non-prescription medications are beyond Astellas' business scope. To engage in its core business, Astellas has been consistently pursuing its global category leader (GCL) business model since the merger. Through such a strategy, the company has been establishing a competitive advantage as a market leader in creating innovative high value-added drugs. The company then delivers them globally by focusing on selected multiple therapeutic areas or categories where a high degree of medical needs remain unsatisfied. Astellas has established its position as a GCL in urology and transplants, and has committed its resources to also becoming a GCL in the field of oncology. Other future GCL areas include immunology and infectious diseases, neuroscience, diabetes mellitus complications and kidney diseases. "We're building our competitive advantage by focusing our assets, know-how and technology on these fields," Hatanaka says. "Our competitive strength lies in our network of R&D, marketing and sales, and key opinion leaders strongly built based on our capabilities for the GCL business model." Such an approach has made it possible for the company to create new innovative drugs. With the GCL model serving as its key success driver, Astellas has been able to achieve sustainable growth and resiliently respond to environmental and market changes. Expanding global business True enough, the adoption of the business model has paid off as the company has grown steadily in the past several years. Today, Astellas is the second-largest pharmaceutical company for proprietary ethical drugs in Japan, which is the second-biggest pharmaceutical market in the world besides the United States. Globally, Astellas ranks as one of the top 20 pharmaceutical companies. The Astellas Group has about 18,000 employees on a global basis. The company has been expanding its business globally from Japan to the Americas and Europe with its own distribution channels in about 50 countries around the world. These channels are driven by a sales force of about 6,300 medical representatives (MRs). Astellas has a well-balanced global business spanning Japan, the Americas and Europe and wants to deliver its innovative high value-added drugs broadly to patients around the world. The company is expanding its business in the Asia and Oceania regions under the same concept. Astellas has achieved high double-digit growth rates across these regions. In July last year, Astellas set up a sales affiliate in Singapore to support its expansion in the area by securing distribution channels in Singapore, Malaysia and Brunei. This enabled Astellas to consolidate its business expansion with 10 sales subsidiaries in the Asia and Oceania regions. "China is the centre of our regional market expansion," Hatanaka says. "It accounts for about half of our total sales in the Asia and Oceania regions, driven by a sales force of about 720 MRs. We'll capture this market opportunity through the expanded marketing of our global products. We would also like to build a comprehensive strategy, which includes strengthening regional R&D capabilities in the future in the Asia and Oceania regions." In the two established GCL areas, immunosuppressant Prograf is a mainstay product in the transplantation franchise. Vesicare and Betanis/Myrbetriq/BETMIGA, which are treatments for an overactive bladder (OAB), are contributing to the growth of the OAB franchise in the urology area. With its generic name solifenacin, Vesicare has created a worldwide success as a reliable treatment for OAB. With its generic name mirabegron, Betanis/Myrbetriq/BETMIGA is Astellas' driving force to further become an established GCL in the area of urology. Establishing oncology as third GCL Astellas is also gaining traction in cancer treatment. "We would like to establish our business platforms, especially for oncology as our third GCL domain," Hatanaka says. "We've been actively investing in this area since we declared our intention to enter this field in 2006." The company's key to building a leading position in the field of oncology lies in its latest prostate cancer treatment, XTANDI. Because XTANDI is an anti-cancer agent in the therapeutic area of urology, where Astellas commands a strong position, the company expects to achieve beneficial synergies with this existing business. XTANDI was launched in September 2012 in the US, in July last year in Britain and in Japan last May for the indication of metastatic castration-resistant prostate cancer in patients who have previously received docetaxel chemotherapy. The drug has been introduced in more than 20 countries under the XTANDI brand. The company is strengthening its oncology franchise by expanding the drug's indications or treatment coverage. Ensuring sustained growth "We see promising growth in the global pharmaceutical market in the future," Hatanaka says. "While medical needs are continuously increasing globally, the innovative drug review system is improving in each country." Among the strongest drivers of industry growth, however, is the increasing value placed by governments and health care institutions worldwide on the concept of "breakthrough therapy designation". It is a process designed to expedite the development and review of innovative drugs that are intended to treat a serious or life-threatening disease or symptom. To be considered under such designation, the drug must demonstrate preliminary clinical evidence indicating it brings substantial improvement over available therapy. To capture this forecast global expansion in the pharmaceutical industry, Astellas will pursue its GCL strategy and has committed to achieve sustainable expansion into the future. For its sustainable growth, the company is focused on three strategic challenges - maximising the value of new innovative products, enhancing innovation and pursuing operational excellence. The first challenge of maximising the value of new innovative products comes about as the company tries to offset the effects of the so-called patent cliff. As Astellas focuses on the innovative drug business, it will likely face a decline in sales after the patent expiration of some of its products. Astellas heads this off by committing to maximise the value of its new innovative products with a focus on its future growth drivers. These medications include XTANDI in the oncology franchise and Vesicare and Betanis/Myrbetriq/BETMIGA in the OAB franchise in urology. The second challenge is enhancing innovation. "We have re-examined the allocation of R&D resources and have been reshaping our research framework since last year as a part of this challenge," Hatanaka says. "We have, for example, started a new research management system last April. This strategy includes strengthening the authority and responsibility in each therapeutic area to enhance the autonomy and agility of each unit. This is to actively leverage more external innovation, utilising more of its capabilities and resources." The third challenge is pursuing operational excellence. Astellas is accelerating its initiatives aiming to build the organisation and structure to resiliently respond to environmental changes. As one of its achievements, the company has improved its global pharmacovigilance or drug safety structure by establishing its Global Pharmacovigilance Excellence Program. The move ensures compliance with regulatory requirements in each country and organically integrates the process under the control of the chief medical officer. Passionate about changing tomorrow Astellas, however, recognises that small things matter as much as its big initiatives. With a management based on corporate social responsibility, the company has supported many activities that give patients and their families courage in battling illnesses. These projects include funding for patient groups, peer support training programmes and web-based information services. Astellas has adopted the communication slogan, "Changing tomorrow", reflecting its desire to help each patient by continuously creating innovative drugs. Named after this slogan, the "Changing Tomorrow Day" is Astellas' group-wide effort to contribute to local communities. For example, last year, employees from the Kurume sales office in Japan interacted with people in aged care facilities by cleaning the premises and assisting in recreational activities such as origami and singing children's songs. In China, Astellas' employees take time to discuss the importance of medicines with grade school students. "Patients are at the frontline of our business, and we deliver the progress of science by transforming it into values that will benefit them," Hatanaka says. "Although this may sound natural and nothing new, we make sure our employees never forget that all our efforts are for the patients. This is the value we rely on every day." Astellas Pharma www.astellas.com
