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 sympto ...

, 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 Corpor ...

(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 2. ...

, 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 largest city of Japan. Formerly known as Edo, its metropolitan area () is the most populous in the world, with an estimated 37.468 ...

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 nort ...

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 Boo ...

. Yamanouchi's R&D center in

Leiderdorp Leiderdorp () is a town and municipality in the western Netherlands, in the province of South Holland near the city of Leiden. It had a population of in . The municipality covers an area of of which is water. Leiderdorp has now become a suburb ...

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 Alzheimer's disease (AD) is a neurodegeneration, neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in short-term me ...

. 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. On June 9, 2010, Astellas acquired

OSI Pharmaceuticals OSI Pharmaceuticals, Inc. was an American pharmaceutical company formerly based on Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. On Sunday, May 16, 2010 OSI agreed to be acquired by Japan-based, TSE-listed ...

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 genetic ...

and possibly other

neuromuscular A neuromuscular junction (or myoneural junction) is a chemical synapse between a motor neuron and a muscle fiber. It allows the motor neuron to transmit a signal to the muscle fiber, causing muscle contraction. Muscles require innervation t ...

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 Astellas Institute for Regenerative Medicine is a subsidiary of Astellas Pharma located in Marlborough, Massachusetts, US, developing stem cell therapies with a focus on diseases that cause blindness. It was formed in 1994 as a company named ...

(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 LEO Pharma A/S is a multinational Danish pharmaceutical company, founded in 1908, with a presence in about 100 countries. Its headquarters are in Ballerup, near Copenhagen The company is 100% integrated into a private foundation owned by the LEO F ...

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. 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 fol ...

and age-related

diseases A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that ar ...

. 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 Peficitinib (trade name Smyraf) is a pharmaceutical drug used for the treatment of rheumatoid arthritis. It belongs to the class of drugs known as Janus kinase inhibitor A Janus kinase inhibitor, also known as JAK inhibitor or jakinib, is a typ ...

(ingredient:

peficitinib Peficitinib (trade name Smyraf) is a pharmaceutical drug used for the treatment of rheumatoid arthritis. It belongs to the class of drugs known as Janus kinase inhibitor A Janus kinase inhibitor, also known as JAK inhibitor or jakinib, is a typ ...

) obtained regulatory approval for the treatment of

rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are involv ...

, 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 The Association of the British Pharmaceutical Industry (ABPI) is the trade association for over 120 companies in the UK producing prescription medicines for humans, founded in 1891.

(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 federal executive department of the United States government tasked with the enforcement of federal law and administration of justice in the United State ...

$100 million to resolve allegations that it had conspired to offer

kickbacks A kickback is a form of negotiated bribery in which a commission is paid to the bribe-taker in exchange for services rendered. Generally speaking, the remuneration (money, goods, or services handed over) is negotiated ahead of time. The kickback ...

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 there ...

( 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 heart d ...

, 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 dise ...

. Priority areas for R&D are

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 ap ...

gastrointestinal disease Gastrointestinal diseases (abbrev. GI diseases or GI illnesses) refer to diseases involving the gastrointestinal tract, namely the oesophagus, stomach, small intestine, large intestine and rectum, and the accessory organs of digestion, the liver ...

, 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 par ...

. 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 building ...

injection) – Pharmacologic stress agent for

myocardial perfusion scan Myocardial perfusion imaging or scanning (also referred to as MPI or MPS) is a nuclear medicine procedure that illustrates the function of the heart muscle (myocardium). It evaluates many heart conditions, such as coronary artery disease (CAD), h ...

* Adenoscan (adenosine injection) – Pharmacologic stress agent for

* AmBisome (

amphotericin B Amphotericin B is an antifungal medication used for serious mycosis, fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candida infections, candidiasis, coccidioidomy ...

) – 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 CO ...

. * Amevive (

alefacept Alefacept is a genetically engineered immunosuppressive drug. It was sold under the brand name Amevive in Canada, the United States, Israel, Switzerland and Australia. In 2011, the manufacturers made a decision to cease promotion, manufacturing ...

) – 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 complete ...

* 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 also ...

) – Prevention of post- transplant

organ rejection Transplant rejection occurs when transplanted tissue is rejected by the recipient's immune system, which destroys the transplanted tissue. Transplant rejection can be lessened by determining the molecular similitude between donor and recipient a ...

* Cresemba (

isavuconazole Isavuconazonium sulfate, sold under the brand name Cresemba, is a systemic antifungal medication of the triazole class which is used to treat invasive aspergillosis and mucormycosis. The most common side effects include abnormal liver tests, ...

) – Anti-fungal * Evrenzo (

roxadustat Roxadustat, sold under the brand name Evrenzo, is an anti-anemia medication. Roxadustat is a HIF prolyl-hydroxylase inhibitor that increases endogenous production of erythropoietin and stimulates production of hemoglobin and red blood cells. It ...

) - 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, vo ...

(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 o ...

(BPH) **Flomax MR capsules were discontinued in 2005, replaced by Flomaxtra XL, containing the same active ingredient * Lexiscan (

regadenoson Regadenoson, sold under the brand name Lexiscan among others, is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a durati ...

injection) – Pharmacologic stress agent for

* 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 1999 ...

sodium) –

Anti-angiogenic An angiogenesis inhibitor is a substance that inhibits the growth of new blood vessels (angiogenesis). Some angiogenesis inhibitors are endogenous and a normal part of the body's control and others are obtained exogenously through pharmaceutical dru ...

– marketed with

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 Pfizer ...

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 Mirabegron, sold under the brand name Myrbetriq among others, is a medication used to treat overactive bladder. Its benefits are similar to antimuscarinic medication such as solifenacin or tolterodine. It is taken by mouth. Common side effec ...

) –

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

Outside of US. * Padcev ( enfortumab vedotin) -

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 mali ...

* Prograf (

) – Prevention of post- transplant

* Protopic (

ointment) – Atopic dermatitis (

eczema Dermatitis is inflammation of the Human skin, skin, typically characterized by itchiness, erythema, redness and a rash. In cases of short duration, there may be small blisters, while in long-term cases the skin may become lichenification, thick ...

) * 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 heroin ...

HCL HCL may refer to: Science and medicine * Hairy cell leukemia, an uncommon and slowly progressing B cell leukemia * Harvard Cyclotron Laboratory, from 1961 to 2002, a proton accelerator used for research and development * Hollow-cathode lamp, a spe ...

) –

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. Op ...

* Tarceva (

erlotinib Erlotinib, sold under the brand name Tarceva among others, is a medication used to treat non-small cell lung cancer (NSCLC) and pancreatic cancer. Specifically it is used for NSCLC with mutations in the epidermal growth factor receptor (EGFR) � ...

) – 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 tissue (biology), tissues of the lung. Lung carcinomas derive from tran ...

and

pancreatic cancer Pancreatic cancer arises when cell (biology), cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a Neoplasm, mass. These cancerous cells have the malignant, ability to invade other parts of t ...

– 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 Conivaptan, sold under the brand name Vaprisol, is a non-peptide inhibitor of the receptor for anti-diuretic hormone, also called vasopressin. It was approved in 2004 for hyponatremia (low blood sodium levels). The compound was discovered by As ...

) –

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 abs ...

* Vesicare (

solifenacin Solifenacin, sold as the brand name Vesicare among others, is a medicine used to treat overactive bladder and neurogenic detrusor overactivity (NDO). It may help with urinary incontinence, incontinence, urinary frequency, and urinary urgency. ...

succinate) –

(OAB) * Vibativ (

telavancin Telavancin (trade name Vibativ) is a bactericidal lipoglycopeptide for use in MRSA or other Gram-positive infections. Telavancin is a semi-synthetic derivative of vancomycin. The FDA approved the drug in September 2009 for complicated skin and ...

) –

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 Lipoglycopeptides are a class of antibiotic that have lipophilic side-chains linked to glycopeptides. The class includes oritavancin, telavancin and dalbavancin. In September 2009 the US Food and Drug Administration (FDA) approved telavancin (Vib ...

– marketed with Theravance. * Xospata (

gilteritinib Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug. It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor. It was developed by Astellas Pharma. In April 2018, Astellas filed a new drug application w ...

) –

AXL receptor tyrosine kinase Tyrosine-protein kinase receptor UFO is an enzyme that in humans is encoded by the ''AXL'' gene. The gene was initially designated as UFO, in allusion to the unidentified function of this protein. However, in the years since its discovery, resear ...

* 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 castrat ...

) –

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 sur ...

– marketed with

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 Alliance Healthcare, formerly Alliance UniChem, wholesales, distributes, and retails pharmaceutical, surgical, medical, and healthcare products throughout Europe. The company supplies more than 110,000 pharmacies, doctors, health centres and hos ...

, and Phoenix Healthcare Distribution.

Operations

The company's headquarters are in