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Astellas Pharma Inc.
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Vision/Mission
Astellas’ raison d’être is to, "contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products." Based on this statement, we aim to stand on the forefront of healthcare change, turning innovative science into value for patients.
Business Description
Astellas Pharma Inc. is a top 25 global pharmaceutical research company, headquartered in Tokyo, Japan. The company is committed to turning innovative science into medical solutions that bring value and hope to patients worldwide. Astellas continues to enhance its core capabilities to deliver innovative medical solutions in urology, oncology, immunology, nephrology and neuroscience as therapeutic areas with high unmet medical needs. Additionally, the company is advancing new therapeutic areas including muscle disease and ophthalmology and new technologies and modalities, such as next-generation vaccines and regenerative medicine. Keeping its focus on addressing unmet medical needs and conducting its business with openness, integrity and a collaborative approach enables Astellas to improve the health of people around the world.
Background
As a global pharmaceutical company, Astellas is focused on expanding new drugs and growth products, and creating innovative medicines that will help it to achieve sustainable growth.
Astellas was formed in 2005 through the merger of two Japanese pharmaceutical companies, Yamanouchi Pharmaceutical Co. and Fujisawa Pharmaceutical Co., which combined nearly two centuries of collective pharmaceutical expertise. Both companies were focused on becoming a leading Japan-based research and development (R&D)-oriented global pharmaceutical firm, and made the decision to merge in order to make their goal a reality.
Leveraging the deep history, complementary expertise, geographic reach and combined resources of both companies, Astellas was able to achieve success in a very short period of time. One of the key successes of the merger was that the swift integration of employees from both companies enabled the new company to quickly respond to external environmental changes. The biggest achievement is that Astellas could enter the oncology market with a substantial commitment and investment in R&D. One year after the merger, the company decided to make oncology its core area of research. In a little over a decade, Astellas has established a leadership position and a substantial pipeline in oncology.
Astellas Pharma Inc., the parent company, is publicly traded on the Tokyo Stock Exchange. The company has adopted the organizational structure of "Company with Audit & Supervisory Board." Outside Directors and outside Audit & Supervisory Board Members constitute the majority of the Board of Directors and the Audit & Supervisory Board, respectively. The Board of Directors principally serve as the oversight function for the execution of business, and also make decisions on important business execution. As organs for handling the execution of business, the company has established an Executive Committee and the Japan Management Committee for discussing important matters, and also appoints Executive Officers who are responsible for their respective assigned departments or functions.
All Astellas employees live "the Astellas Way" for patients and for each other. The Astellas Way is the company’s shared set of values that helps guide its actions and decisions, with a focus on patients, ownership, results, openness and integrity.
Through persistent dialogue with multiple stakeholders to create new value and by anticipating changes that are turned into opportunities which lead to continual business evolution, Astellas will remain a company of choice.
Products/Services
XTANDI® (enzalutamide): An androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown.
XTANDI is currently approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) based on clinical data from previous studies that showed a statistically significant overall survival benefit for XTANDI versus placebo in the metastatic CRPC setting. XTANDI has been prescribed to more than 185,000 patients globally since its first approval in 2012.
See Important Safety Information
here
for reference.
Please see
Full Prescribing Information
for additional safety information.
Betanis® / Myrbetriq® / BETMIGA® (mirabegron): A prescription medicine for adults used to treat overactive bladder (OAB) with symptoms of urgency, frequency and leakage. It is the first and only drug in its class for OAB as a beta-3 adrenergic receptor agonist. It is sold in around 50 countries and regions worldwide under the brand name of Betanis in Japan, Myrbetriq in the Americas and BETMIGA in EMEA and Asia & Oceania.
See Important Safety Information
here
for reference.
For further information, please talk to your healthcare professional and see accompanying
Patient Product Information
and complete
Prescribing Information.
Vesicare® (solifenacin succinate): This is an anticholinergic drug sold in approximately 80 countries and regions. Once-daily VESIcare can help control the
bladder
muscle and has been demonstrated to treat OAB with symptoms of frequent urges and leaks.†
†Your results may vary.
See Important Safety Information
here
for reference.
For further information, please talk to your healthcare professional and see accompanying
Patient Product Information
and complete
Prescribing Information
for VESIcare® (solifenacin succinate).
Prograf® (tacrolomis): A prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant. It has made a significant global contribution to the field of transplantation.
IMPORTANT SAFETY INFORMATION
Most lmportant lnformation to Know
How to Take
Side Effects
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Please see the accompanying
Patient Information
and full
Prescribing Information
, including Boxed Warnings.
Markets
Astellas has its own distribution channels in more than 50 countries around the world, with operations in four major regions: Japan (global headquarters), the Americas, EMEA (Europe, Middle East and Africa) and Asia & Oceania. It has implemented growth strategies according to regional characteristics.
Japan
The region is proactively transforming changes in the healthcare environment, such as optimized healthcare expenditures and healthcare delivery systems, into opportunities. The number of highly specialized products, such as XTANDI and Repatha® (evolocumab) for hypercholesterolemia, are increasing. The region is evolving toward a patient-centric, optimized sales promotion structure.
Americas
The region has been actively working to address the rapidly evolving U.S. healthcare system by engaging in constructive dialogue with various stakeholders. In its core therapeutic areas, the region will continue to focus on achieving growth in the oncology and urology franchises, while also gaining efficiencies in immunology, transplant and cardiology.
EMEA
The region is working to establish optimal sales strategies for each country, in conjunction with optimizing the allocation of resources and maximizing product value, with the aim of achieving sustained growth. Going forward, Astellas will continue to serve patients by delivering innovative pharmaceuticals in major therapeutic areas, such as oncology.
Asia & Oceania
Significant market growth is expected to continue in the Asia & Oceania region. The region aims to provide high-value-added pharmaceutical products and further expand its business. XTANDI, BETMIGA and Feburic® (febuxostat), which is for hyperuicemia, will be among the products supporting their growth going forward.
Industry
Astellas is part of the global pharmaceutical industry. Astellas is one of the largest pharmaceutical companies in Japan and among the top 25 globally.
Location
Headquartered in Tokyo, Japan, Astellas is a global pharmaceutical company with locations across its four regions: Japan, the Americas, EMEA and Asia & Oceania. This allows the company to provide global coverage while reflecting the regional needs of each market.
Competitive Advantages
Over the past decade, the company has demonstrated robust growth, developing ground-breaking new medicines in urology, transplantation, infectious diseases and oncology. Its patient focused approach is governed by long-term strategy rather than short-term economics, meaning decision-making and planning can focus on ensuring that the company’s advances have the best chance of sustained success. At Astellas, we combine our internal capabilities and strengths with external strengths to deliver groundbreaking solutions that address patients’ unmet needs.
The largest disease area of focus for Astellas is oncology. We are committed to delivering innovative science that brings value to patients living with cancer. We already deliver world-class treatments for prostate, non-small cell lung cancer and pancreatic cancers, and are now developing a robust pipeline, directed at some of the hardest-to-treat cancers utilizing novel modalities and technologies.
Financial Projection
As announced in April 2017, the forecasts for the fiscal year ending March 31, 2018 ("FY2017") (core basis) are as follows: The sales forecast is 1,279.0 billion yen (-2.5% year-on-year).
While we anticipate continuous sales growth for XTANDI®, our mainstay product, and also for OAB treatments due to the growth of Betanis® / Myrbetriq® / BETMIGA®, we expect negative impact on sales and profit from the transfer of the global dermatology business implemented in April 2016 and the transfer of long-listed products in Japan for which an agreement was concluded in March 2017. We project a core operating profit of 254.0 billion yen (-7.5% year-on-year). However, we forecast core operating profit excluding the factors associated with the transfers of the dermatology business and long-listed products in Japan as stated above and the impact of the foreign exchange to be higher year-on-year.
Company Goals & Objectives
In order to achieve our business philosophy to, "contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products," we focus our resources on the innovative drug business and maximizing our strengths to create new medical solutions for diseases with unmet medical needs.
We view environmental changes in healthcare from multiple perspectives and continuously seek out business opportunities. And we see change as an opportunity and aim for further growth by focusing on the long-term potential. This is the concept behind our VISION: to be on the forefront of healthcare change to turn innovative science into value for patients.
We will turn changes into opportunities by creating innovative new drugs and medical solutions, leveraging our core capabilities;
We will go beyond global category leadership by viewing business opportunities from multiple perspectives and embracing change.
We will create innovative medical solutions by combining a variety of internal and external healthcare capabilities.
The Astellas three-year strategic plan for 2015-17 was designed to create growth over the mid-to-long-term through the pursuit of three main strategies ‘Maximizing Product Value’, ‘Creating Innovation’ and ‘Pursuing Operational Excellence’.
Specializing in the new drug business, we cannot grow without continuously generating innovation. In the short-term, maximizing current products is driving our growth. New products will drive mid-term growth, and sustainable growth will be reinforced by continuous, selective investment in innovation and strengthening our business foundation. Over the long-term, our drivers are coming from the early-phase pipeline including new therapeutic categories. Further, we expect innovative treatments for a broad range of diseases by leveraging new technology and modality platforms.
Management
Astellas’ president and chief executive officer (CEO) is Yoshihiko Hatanaka, and he has held these roles since 2011. Previously, he served as chief financial officer and chief strategy officer for Astellas. He also was president and CEO of Astellas US LLC and Astellas Pharma US, Inc.
Employees
Astellas has more than 17,000 employees around the world. Astellas’ employees are its greatest strength. They are the driving force to realize our corporate vision and business philosophy.
Highlights
Astellas was created in 2015 following the merger of Yamanouchi and Fujisawa. Since that point, the company has steadily grown in its therapeutic areas of research focus, with a particular emphasis in oncology. One of our key success factors for the oncology franchise growth during the short term has been combining Astellas’ strengths and capabilities with external capabilities.
In 2007, we first entered the oncology space by acquiring a company which specialized in therapeutic antibody research and development in cancer;
In 2009, we reached development and commercial agreements with Medivation (later acquired by Pfizer) for XTANDI;
In 2010, to enter into a crowded oncology market in the U.S., we acquired OSI Pharmaceuticals in New York;
Just last year we acquired Ganymed Pharmaceuticals in Mainz, Germany which specializes in late-stage oncology research.
These are our greatest achievements for cancer patients since Astellas’ establishment.
Other Notes
We highly value our long-term partnerships. We aim to be the partner of choice and collaborate with numerous organizations in the public and private sectors including leading academia and biotech companies.
We seek out partners who share a similar vision, who complement our expertise and who can help us accelerate ground-breaking science and innovation in our therapeutic areas of focus.
Over the past few years, we have established more than 20 joint research programs with external institutions and biotechnology companies.
We believe that integrating strengths, capabilities and cultures creates great synergy and new value for patients. Moreover, we continue to actively explore and capture external business opportunities through acquisition, collaboration and in-licensing. These efforts enable us to accelerate the pace of innovation and more quickly bring innovative drugs and technologies to patients to address unmet medical needs.
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