Astellas Pharma: Difference between revisions

| key_people    = Naoki Okamura<br /><small>([[President (corporate title)|President]] and [[:en:CEO|CEO]])</small><br />Kenji Yasukawa<br /><small>([[:en:Chairman of the Board|Chairman of the Board]])</small>

Fujisawa acquired Lyphomed in 1990 and thereafter established its US R&D center in [[Deerfield, Illinois]]. 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 [[BACE inhibitor|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 [[Medicines and Healthcare products Regulatory Agency|MHRA]].

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]] 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 March 2017, the company sold 16 of its drugs to LTL Pharma for ¥20.1 billion ($133 million). 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]] and age-related [[diseases]].

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]], the third oral Janus kinase (JAK) inhibitor to receive approval.

In May 2023, the business announced it would acquire Iveric Bio for $5.9 billion. In November, Astellas announced it would acquire Propella Therapeutics, Inc. and its lead androgen biosynthesis inhibitor [[abiraterone decanoate]] (PRL-02) used to treat prostate cancer.

*'''Astellas Pharma'''

**Fujisawa Pharmaceutical Co

***Fujisawa Pharmaceutical Co <small>(Est 1894)</small>

***Lyphomed <small>(Acq 1990)</small>

**Yamanouchi Pharmaceutical Co <small>(Est 1923)</small>

**[[OSI Pharmaceuticals]] <small>(Acq 2010)</small>

**[[Ocata Therapeutics]] <small>(Acq 2016)</small>

**Ganymed Pharmaceuticals <small>(Acq 2016)</small>

**Potenza Therapeutics, Inc. <small>(Acq 2018)</small>

**Audentes Therapeutics Inc. <small>(Acq 2019)</small>

**Xyphos Biosciences, Inc. <small>(Acq 2019)</small>

**iota Biosciences, Inc. <small>(Acq 2020)</small>

**Iveric Bio <small>(Acq 2023)</small>

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 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]] $100 million to resolve allegations that it had conspired to offer [[Kickback (bribery)|kickbacks]] via Medicare copay foundations.

Astellas' franchise areas are [[oncology]], [[urology]], [[immunology]] ([[Organ transplant|transplantation]]), [[cardiology]], and [[infectious disease]]. Priority areas for R&D are [[infectious disease]]s, [[diabetes]], [[gastrointestinal disease]]s, [[oncology]], and diseases of the [[central nervous system]].

Recently noted, Astellas Venture Management has funded Oncorus, which recently raised $79.5 million in a [[series B financing]] round to move two oncolytic viruses through development.

* Adenocard ([[adenosine]] injection) – Pharmacologic stress agent for [[myocardial perfusion scan]]

* Adenoscan (adenosine injection) – Pharmacologic stress agent for [[myocardial perfusion scan]]

* AmBisome ([[amphotericin B]]) – [[Antifungal medication|Anti-fungal]] – marketed with [[Gilead Sciences]].

* Amevive ([[alefacept]]) – plaque [[psoriasis]]

* Astagraf XL ([[tacrolimus]]) – Prevention of post-[[organ transplantation|transplant]] [[organ rejection]]

* Cresemba ([[isavuconazole]]) – [[Antifungal medication|Anti-fungal]]

* Evrenzo ([[roxadustat]]) - Anemia due to [[chronic kidney disease]] (CKD)

* Flomax ([[tamsulosin]] hydrochloride) – [[Benign prostatic hyperplasia]] (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]] sodium) – [[Anti-angiogenic]] – marketed with [[Gilead Sciences]] in the US and [[Pfizer]] Outside of US.

* Mycamine ([[micafungin]] sodium) – [[Antifungal medication|Anti-fungal]]

* Myrbetriq ([[mirabegron]]) – [[Overactive bladder]] (OAB) – US only; marketed by [[Pfizer]] Outside of US.

* Padcev ([[enfortumab vedotin]]) - [[Bladder cancer]]

* Prograf ([[tacrolimus]]) – Prevention of post-[[organ transplantation|transplant]] [[organ rejection]]

* Protopic ([[tacrolimus]] ointment) – Atopic dermatitis ([[eczema]])

* Symoron ([[methadone]] [[Hydrochloride|HCL]]) – [[Opioid replacement therapy]]

* Tarceva ([[erlotinib]]) – Non-small cell [[lung cancer]] and [[pancreatic cancer]] – marketed with [[Hoffmann-La Roche]] (Genentech).

* Vaprisol ([[conivaptan]]) – [[Hyponatremia]]

* Veozah ([[fezolinetant]]) - [[Hot flash|Hot Flashes]] (vasomotor symptoms) due to [[menopause]]

* Vesicare ([[solifenacin]] succinate) – [[Overactive bladder]] (OAB)

* Vibativ ([[telavancin]]) – [[bactericidal]] [[lipoglycopeptide]] – marketed with [[Theravance]].

* Xospata ([[gilteritinib]]) – [[AXL receptor tyrosine kinase]]

* Xtandi ([[enzalutamide]]) – [[Prostate cancer]] – marketed with [[Pfizer]].

The US Food and Drug Administration (FDA) has granted priority review to Astellas Pharma's biologics licence application (BLA) for [[Zolbetuximab]], a monoclonal antibody targeting [[Claudin]] 18.2 (CLDN18.2), for the treatment of HER2-negative gastric or gastroesophageal junction [[Adenocarcinoma|adenocarcinoma]]. Zolbetuximab is the first treatment of its kind in the region, and a decision on its approval is expected by 12 January 2024, based on the Phase III SPOTLIGHT and GLOW [[clinical trial]] results.

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.

The company's headquarters are in [[Tokyo]], with [[research]] centers in [[Tsukuba]] and [[Osaka]]. Clinical development is centered in [[Northbrook, Illinois]], [[La Jolla, California]], and [[Leiden]], 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]]s are:

* English: '''Leading Light for Life'''

* Japanese: {{nihongo|'''Ashita wa kaerareru.'''|明日は変えられる。|Changing Tomorrow.}}