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is a Japanese multinational
pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympt ...
, formed on 1 April 2005 from the merger of and . On February 5, 2020, the company announced management changes effective from April 1, 2020. Astellas is a member of the
Mitsubishi UFJ Financial Group is a Japanese bank holding and financial services company headquartered in Chiyoda, Tokyo, Japan. MUFG holds assets of around US$3.1 trillion as of 2016 and is one of the "Three Great Houses" of the Mitsubishi Group alongside Mitsubishi C ...
(MUFJ)
keiretsu A is a set of companies with interlocking business relationships and shareholdings. In the legal sense, it is a type of informal business group that are loosely organized alliances within the social world of Japan's business community. The ''ke ...
.


History


Early foundations

Fujisawa Shoten was started in 1894 by Tomokichi Fujisawa in
Osaka is a designated city in the Kansai region of Honshu in Japan. It is the capital of and most populous city in Osaka Prefecture, and the third most populous city in Japan, following Special wards of Tokyo and Yokohama. With a population of ...
, and was renamed Fujisawa Pharmaceutical Co. in 1943. Yamanouchi Yakuhin Shokai was started in 1923 by Kenji Yamanouchi in Osaka. The company was renamed Yamanouchi Pharmaceutical Co. in 1940 and moved to
Tokyo Tokyo (; ja, 東京, , ), officially the Tokyo Metropolis ( ja, 東京都, label=none, ), is the capital and List of cities in Japan, largest city of Japan. Formerly known as Edo, its metropolitan area () is the most populous in the world, ...
in 1942. Both companies started their overseas expansion at about the same time, opening offices in
Taiwan Taiwan, officially the Republic of China (ROC), is a country in East Asia, at the junction of the East and South China Seas in the northwestern Pacific Ocean, with the People's Republic of China (PRC) to the northwest, Japan to the northe ...
in 1962 and 1963, respectively, and in the United States and Europe from 1977 onwards.


Recent times and mergers

Fujisawa acquired Lyphomed in 1990 and thereafter established its US R&D center in
Deerfield, Illinois Deerfield is a north shore suburb of Chicago in Lake County, Illinois, United States, with a small portion extending into Cook County, Illinois. The population was 19,196 at the 2020 census. Deerfield is home to the headquarters of Walgreens Bo ...
. Yamanouchi's R&D center in Leiderdorp was established with the acquisition of the pharmaceutical division of Royal Gist Brocades in 1991. Fujisawa and Yamanouchi combined in a "merger of equals," forming Astellas Pharma on 1 April 2005. At least some of its older products continue to be distributed under the original brand, ostensibly due to high brand-name recognition. Astellas had a collaboration agreement with CoMentis from 2008 to 2014 focused on development of beta-secretase inhibitor therapeutics for Alzheimer's disease. In 2009, the company's tacrolimus-containing products Prograf and Advagraf showed they were prone to dosing errors within Europe, leading to serious adverse reactions among a number of patients, due to deficits in packaging and labeling, deficits corrected after a warning from the UK
MHRA MHRA may refer to: Organisations * Medicines and Healthcare products Regulatory Agency, UK * Michigan Hot Rod Association, US * Modern Humanities Research Association, UK ** ''MHRA Style Guide'', an academic style guide Other uses * Men's human r ...
. On June 9, 2010, Astellas acquired OSI Pharmaceuticals for $4.0 billion. In December 2014, Astellas expanded its 18-month-old collaboration with Cytokinetics, focusing on the R&D and commercialization of skeletal muscle activators. The companies announced they will advance the development of CK-2127107 (a fast skeletal troponin activator) into Phase II clinical trials for the treatment of
spinal muscular atrophy Spinal muscular atrophy (SMA) is a rare neuromuscular disorder that results in the loss of motor neurons and progressive muscle wasting. It is usually diagnosed in infancy or early childhood and if left untreated it is the most common genet ...
and possibly other neuromuscular conditions. The collaboration was expected to generate more than $600 million for Cytokinetics, as well as $75 million in milestone payments. In November 2015, the company announced its move to acquire Ocata Therapeutics (formerly Advanced Cell Technology) for $379 million. The deal was completed in February 2016. Later in November 2015 the company announced it would sell its dermatology business to LEO Pharma for $725 million. In October 2016 Astellas announced it would acquire Ganymed Pharmaceuticals for $1.4 billion In April 2017, the company announced it would acquire Belgium-based drug discovery firm Ogeda for up to a total €800 million, strengthening its late-stage pipeline with Ogeda's drug candidate,
fezolinetant Fezolinetant (; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development by Ogeda (formerly Euroscreen) for the treatment of sex hormone-related dis ...
. In November 2017, the company announced that it exercised an option to purchase Cambridge, Massachusetts-based Mitobridge, which is developing treatments for
Duchenne muscular dystrophy Duchenne muscular dystrophy (DMD) is a severe type of muscular dystrophy that primarily affects boys. Muscle weakness usually begins around the age of four, and worsens quickly. Muscle loss typically occurs first in the thighs and pelvis follo ...
and age-related diseases. In August 2018, Astellas announced it would acquire Quethera Limited for $109 million. In December 2018, the company announced it would acquire Potenza Therapeutics, Inc. In December 2019, Astellas Pharma announced it would buy Audentes Therapeutics Inc for approximately $3 billion in cash as well as acquiring Xyphos Biosciences, Inc later in the same month. Audentes will operate as a wholly owned subsidiary within Astellas, and will serve as the Center of Excellence for the newly created Genetic Regulation Primary Focus, providing leadership for AAV pipeline advancement through commercialization, manufacturing expansion, and next-generation research initiatives. The acquisition includes Astellas gaining Xyphos’ Advanced Cellular Control through Engineered Ligands (ACCEL) technology platform. Astellas Pharma's Smyraf (ingredient: peficitinib) obtained regulatory approval for the treatment of
rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects synovial joint, joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and ...
, the third oral Janus kinase (JAK) inhibitor to receive approval. In October 2020, Astellas announced it would acquire iota Biosciences, Inc. for $127.5 million, with shareholders eligible to receive up to a further $176.5 million upon the achievement of predetermined milestones.


Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):


Controversies

In June 2016, the Association of the British Pharmaceutical Industry (ABPI) gave Astellas a year-long suspension, after complaints it had "purposely misled the PMCPA." In particular, Astellas had not fully disclosed the nature of a meeting which had purported to be a "genuine advisory board". In May 2017, the ABPI extended the suspension by a further 12 months, based on findings that Astellas was not adequately overseeing and training nurses, and that it had failed to provide complete prescribing information for several medicines. In June 2017, Astellas was reprimanded for "producing a large number of promotional materials, which had been used for a number of years, that did not include the required prescribing information related to some serious or common adverse reactions, warnings, and precautions, for a total of eight drugs". In December 2018, the Prescription Medicines Code of Practice Authority (PMCPA) published their findings following an allegation that Astellas had "inappropriately awarded research funding" to a senior clinician at a British hospital, directly resulting in the hospital adopting a protocol which was subsequently abandoned less than three years later "because of poor outcomes". This report also reprimanded Astellas for failing to provide sufficient and timely information to investigators. In April 2019, Astellas agreed to pay the
United States Department of Justice The United States Department of Justice (DOJ), also known as the Justice Department, is a United States federal executive departments, federal executive department of the United States government tasked with the enforcement of federal law and a ...
$100 million to resolve allegations that it had conspired to offer kickbacks via Medicare copay foundations.


Business

Astellas' franchise areas are
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
,
urology Urology (from Greek οὖρον ''ouron'' "urine" and '' -logia'' "study of"), also known as genitourinary surgery, is the branch of medicine that focuses on surgical and medical diseases of the urinary-tract system and the reproductive org ...
,
immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see ther ...
( transplantation),
cardiology Cardiology () is a branch of medicine that deals with disorders of the heart and the cardiovascular system. The field includes medical diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular he ...
, and
infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable d ...
. Priority areas for R&D are
infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable d ...
s,
diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level (hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...
, gastrointestinal diseases,
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
, and diseases of the
central nervous system The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain and spinal cord. The CNS is so named because the brain integrates the received information and coordinates and influences the activity of all p ...
. Recently noted, Astellas Venture Management has funded Oncorus, which recently raised $79.5 million in a
series B financing Venture capital financing is a type of funding by venture capital. It is private equity capital that can be provided at various stages or funding rounds. Common funding rounds include early-stage seed funding in high-potential, growth companies ...
round to move two oncolytic viruses through development.


Products

Some of the key products produced by Astellas include: * Adenocard (
adenosine Adenosine (symbol A) is an organic compound that occurs widely in nature in the form of diverse derivatives. The molecule consists of an adenine attached to a ribose via a β-N9-glycosidic bond. Adenosine is one of the four nucleoside buildin ...
injection) – Pharmacologic stress agent for myocardial perfusion scan * Adenoscan (adenosine injection) – Pharmacologic stress agent for myocardial perfusion scan * AmBisome (
amphotericin B Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, and cryptococcosis. Fo ...
) – Anti-fungal – marketed with
Gilead Sciences Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and ...
. * Amevive ( alefacept) – plaque
psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by raised areas of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small, localized patches to complet ...
* Astagraf XL (
tacrolimus Tacrolimus, sold under the brand name Prograf among others, is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given. The drug can als ...
) – Prevention of post-
transplant Transplant or Transplantation may refer to: Sciences *Transplanting a plant from one location to another *Organ transplantation, moving an organ from one body to another *Transplant thought experiment, an experiment similar to Trolley problem *Tra ...
organ rejection * Cresemba ( isavuconazole) – Anti-fungal * Evrenzo ( roxadustat) - Anemia due to
chronic kidney disease Chronic kidney disease (CKD) is a type of kidney disease in which a gradual loss of kidney function occurs over a period of months to years. Initially generally no symptoms are seen, but later symptoms may include leg swelling, feeling tired, ...
(CKD) * Flomax (
tamsulosin Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. The evidence for benefit with a ki ...
hydrochloride) –
Benign prostatic hyperplasia Benign prostatic hyperplasia (BPH), also called prostate enlargement, is a noncancerous increase in size of the prostate gland. Symptoms may include frequent urination, trouble starting to urinate, weak stream, inability to urinate, or loss ...
(BPH) **Flomax MR capsules were discontinued in 2005, replaced by Flomaxtra XL, containing the same active ingredient * Lexiscan ( regadenoson injection) – Pharmacologic stress agent for myocardial perfusion scan * Macugen (
pegaptanib Pegaptanib sodium injection (brand name Macugen) is an anti-angiogenic medicine for the treatment of neovascular (wet) age-related macular degeneration (AMD). It was discovered by NeXstar Pharmaceuticals (which merged with Gilead Sciences in 199 ...
sodium) – Anti-angiogenic – marketed with
Gilead Sciences Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and ...
in the US and
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...
Outside of US. * Mycamine (
micafungin Micafungin, sold under the brand name Mycamine, is an echinochandin antifungal medication used to treat and prevent invasive fungal infections including candidemia, abscesses, and esophageal candidiasis. It inhibits the production of beta-1,3-g ...
sodium) – Anti-fungal * Myrbetriq ( mirabegron) –
Overactive bladder Overactive bladder (OAB) is a condition where there is a frequent feeling of needing to urinate to a degree that it negatively affects a person's life. The frequent need to urinate may occur during the day, at night, or both. If there is loss ...
(OAB) – US only marketed by
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...
Outside of US. * Padcev (
enfortumab vedotin Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody ...
) -
Bladder cancer Bladder cancer is any of several types of cancer arising from the tissues of the urinary bladder. Symptoms include blood in the urine, pain with urination, and low back pain. It is caused when epithelial cells that line the bladder become ma ...
* Prograf (
tacrolimus Tacrolimus, sold under the brand name Prograf among others, is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given. The drug can als ...
) – Prevention of post-
transplant Transplant or Transplantation may refer to: Sciences *Transplanting a plant from one location to another *Organ transplantation, moving an organ from one body to another *Transplant thought experiment, an experiment similar to Trolley problem *Tra ...
organ rejection * Protopic (
tacrolimus Tacrolimus, sold under the brand name Prograf among others, is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given. The drug can als ...
ointment) – Atopic dermatitis (
eczema Dermatitis is inflammation of the skin, typically characterized by itchiness, redness and a rash. In cases of short duration, there may be small blisters, while in long-term cases the skin may become thickened. The area of skin involved can v ...
) * Symoron (
methadone Methadone, sold under the brand names Dolophine and Methadose among others, is a synthetic opioid agonist used for chronic pain and also for opioid dependence. It is used to treat chronic pain, and it is also used to treat addiction to hero ...
HCL) –
Opioid replacement therapy Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. O ...
* Tarceva ( erlotinib) – Non-small cell
lung cancer Lung cancer, also known as lung carcinoma (since about 98–99% of all lung cancers are carcinomas), is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. Lung carcinomas derive from transformed, malign ...
and
pancreatic cancer Pancreatic cancer arises when cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a mass. These cancerous cells have the ability to invade other parts of the body. A number of types of panc ...
– marketed with
Hoffmann-La Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX ...
(Genentech). * Vaprisol ( conivaptan) –
Hyponatremia Hyponatremia or hyponatraemia is a low concentration of sodium in the blood. It is generally defined as a sodium concentration of less than 135  mmol/L (135  mEq/L), with severe hyponatremia being below 120 mEq/L. Symptoms can be a ...
* Vesicare ( solifenacin succinate) –
Overactive bladder Overactive bladder (OAB) is a condition where there is a frequent feeling of needing to urinate to a degree that it negatively affects a person's life. The frequent need to urinate may occur during the day, at night, or both. If there is loss ...
(OAB) * Vibativ ( telavancin) –
bactericidal A bactericide or bacteriocide, sometimes abbreviated Bcidal, is a substance which kills bacteria. Bactericides are disinfectants, antiseptics, or antibiotics. However, material surfaces can also have bactericidal properties based solely on their ...
lipoglycopeptide – marketed with Theravance. * Xospata ( gilteritinib) – AXL receptor tyrosine kinase * Xtandi (
enzalutamide Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castra ...
) –
Prostate cancer Prostate cancer is cancer of the prostate. Prostate cancer is the second most common cancerous tumor worldwide and is the fifth leading cause of cancer-related mortality among men. The prostate is a gland in the male reproductive system that su ...
– marketed with
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...
.


Distribution agreements

In 2007, the company narrowed UK distribution of Advagraf and Prograf to a sole distributor, UniChem, in reaction to pharmacist complaints about drug availability from wholesale sources. This narrow distribution was revised to three firms in 2010, covering all of its products in the UK: AAH, Alliance Healthcare, and Phoenix Healthcare Distribution.


Operations

The company's headquarters are in
Tokyo Tokyo (; ja, 東京, , ), officially the Tokyo Metropolis ( ja, 東京都, label=none, ), is the capital and List of cities in Japan, largest city of Japan. Formerly known as Edo, its metropolitan area () is the most populous in the world, ...
, with
research Research is "creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness t ...
centers in
Tsukuba is a city located in Ibaraki Prefecture, Japan. , the city had an estimated population of 244,528 in 108,669 households and a population density of 862 persons per km². The percentage of the population aged over 65 was 20.3%. The total ar ...
and
Osaka is a designated city in the Kansai region of Honshu in Japan. It is the capital of and most populous city in Osaka Prefecture, and the third most populous city in Japan, following Special wards of Tokyo and Yokohama. With a population of ...
. Clinical development is centered in
Northbrook, Illinois Northbrook is a suburb of Chicago, located at the northern edge of Cook County, Illinois, United States, on the border of Lake County. Per the 2020 census, the population was 35,222. When incorporated in 1901, the village was known as Shermerv ...
,
La Jolla, California La Jolla ( , ) is a hilly, seaside neighborhood within the city of San Diego, California, United States, occupying of curving coastline along the Pacific Ocean. The population reported in the 2010 census was 46,781. La Jolla is surrounded on ...
, and
Leiden Leiden (; in English and archaic Dutch also Leyden) is a city and municipality in the province of South Holland, Netherlands. The municipality of Leiden has a population of 119,713, but the city forms one densely connected agglomeration wit ...
, Netherlands. Combined revenues of the two pre-merger companies were $7.9 billion in 2004. Worldwide the company employs about 17,000 people. The United States subsidiary of Astellas is Astellas US LLC. The company's
advertising slogan Advertising slogans are short phrases used in advertising campaigns to generate publicity and unify a company's marketing strategy. The phrases may be used to attract attention to a distinctive product feature or reinforce a company's brand. Etym ...
s are: * English: Leading Light for Life * Japanese:


Further reading

* *


References


External links

* {{Nikkei 225 Pharmaceutical companies of Japan Life sciences industry Mitsubishi UFJ Financial Group Multinational companies headquartered in Japan Pharmaceutical companies based in Tokyo Pharmaceutical companies established in 2005 Pharmaceutical companies of the Netherlands Japanese brands Japanese companies established in 2005 Companies listed on the Tokyo Stock Exchange TOPIX 100 Companies based in Northbrook, Illinois