Astellas Pharma Inc. (アステラス製薬株式会社 Asuterasu Seiyaku Kabushiki-gaisha) is a Japanese pharmaceutical company, formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd. (山之内製薬株式会社 Yamanouchi Seiyaku Kabushiki-gaisha) and Fujisawa Pharmaceutical Co., Ltd. (藤沢薬品工業株式会社 Fujisawa Yakuhin Kōgyō Kabushiki-gaisha).
(Merged in 2005)
|Founded||1 April 2005|
|Headquarters||2-5-1, Nihonbashi-Honcho, Chūō-ku, Tokyo 103-8411, Japan|
(President and CEO)
|Revenue||US$11,060,000,000 (FY 2013)|
|US$1,280,000,000 (¥1,139,000,000,000) (FY 2013)|
|Total assets||$14.86 billion (2016)|
Number of employees
|Footnotes / references|
Fujisawa Shoten was started in 1894 by Tomokichi Fujisawa in Osaka, 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 in 1942. Both companies started their overseas expansion at about the same time, opening offices in Taiwan in 1962 and 1963, respectively, and in the United States and Europe from 1977 onwards.
Recent times and mergersEdit
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 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.
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 companies have extended their R&D program focusing on the discovery of additional skeletal sarcomere activators through into 2016. The collaboration is 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. As of January 14, 2016, Astellas has not been able to acquire a majority of Ocata's common stock, which is necessary to complete the acquisition. The first deadline in the acquisition was November 17, 2015, and due to Astellas' failure to acquire a majority of Ocata's common stock, the deadline was extended to January 21, 2016. Many long-term stockholders have vowed to fight this acquisition by every legal means available to them, because they claim that the Astellas offer represents a huge discount - not a premium - to what they say is Ocata's true value. The deal was finally completed in February 2016.  Later in November 2015 the company announce 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. 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.
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
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.
Astellas' franchise areas are urology, immunology (transplantation), cardiology, and infectious disease. Priority areas for R&D are infectious diseases, diabetes, gastrointestinal diseases, oncology, and diseases of the central nervous system.
Some of the key products produced by Astellas include:
- Adenocard (adenosine injection) - Pharmacologic stress agent for myocardial perfusion scan
- Adenoscan (adenosine injection) - Pharmacologic stress agent for myocardial perfusion scan
- Advagraf (tacrolimus) - Prevention of post-transplant organ rejection
- AmBisome (amphotericin B) - Anti-fungal - marketed with Gilead Sciences.
- Amevive (alefacept) - plaque psoriasis
- Astagraf XL (tacrolimus) - Prevention of post-transplant organ rejection
- Cresemba (isavuconazole) - Anti-fungal
- Enfortumab vedotin - Antibody-drug conjugate for the treatment of locally advanced or metastatic urothelial carcinoma
- 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) - Anti-fungal
- Myrbetriq (mirabegron) - Overactive bladder (OAB) - US only marketed by Pfizer Outside of US.
- Prograf (tacrolimus) - Prevention of post-transplant organ rejection
- Protopic (tacrolimus ointment) - Atopic dermatitis (eczema)
- Symoron (methadone HCL) - Opioid replacement therapy
- Tarceva (erlotinib) - Non-small cell lung cancer and pancreatic cancer - marketed with Hoffmann-La Roche (Genentech).
- Vaprisol (conivaptan) - Hyponatremia
- Vesicare (solifenacin succinate) - Overactive bladder (OAB) - marketed with GlaxoSmithKline.
- Vibativ (telavancin) - bactericidal lipoglycopeptide - marketed with Theravance.
- Xospata (gilteritinib) - AXL receptor tyrosine kinase
- Xtandi (enzalutamide) - Prostate cancer - marketed with Pfizer.
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 slogans are:
- English: Leading Light for Life
- Japanese: Ashita wa kaerareru. (明日は変えられる。 Changing Tomorrow.)
- "One step ahead of manufacturers' tricky footwork". The Chemist and Druggist (Opinion). Kent, England: CMP Information Ltd. 264 (6520): 15. 12 November 2005 – via Internet Archive.
Manufacturers have, in the past, talked up the importance of bioequivalence to encourage prescribing of their brand.... Astellas is now conveniently ignoring that argument as it attempts to extend the life of Flomax beyond its patent expiry in February 2006.
- "Ridaura Tiltab to cease". The Chemist and Druggist (News brief). Kent, England: CMP Medica. 2721 (6715): 6. 12 September 2009 – via Internet Archive.
- "Astellas Pharma on the Forbes Global 2000 List". Forbes.com. Retrieved 13 August 2018.
- "Corporate Information - Astellas Pharma Inc. GLOBAL WEBSITE". Astellas.com. Retrieved 13 August 2018.
- "Corporate Profile". Astellas Pharma. Retrieved September 9, 2014.
- "Annual Report 2014" (PDF). Astellas Pharma. Retrieved September 9, 2014.
- "Astellas Pharma Snapshot". Bloomberg Businessweek. Retrieved January 25, 2015.
- "Yamanouchi Pimafucin (natamycin) product line manufactured at least up to 11/2007"
- Staff (November 15, 2014). "Astellas Ends Alzehimer's Collaboration with CoMentis". Discovery & Development. Gen. Eng. Biotechnol. News (paper). 34 (20). p. 14.
- Wilkinson, Emma (21 February 2009). "MHRA warns of dosing errors in immune drugs". The Chemist and Druggist. 271 (6686): 10 – via Internet Archive.
- "Astellas, Cytokinetics Expand Muscle Drug Collaboration - GEN". GEN. Retrieved 13 August 2018.
- "Astellas to Acquire Ocata Therapeutics for $379M - GEN". GEN. Retrieved 13 August 2018.
- "Astellas Announces Results of Tender Offer to Acquire All Outstanding Shares of Ocata Therapeutics and Changes to Subsidiaries". Newsroom.astellas.us. Retrieved 13 August 2018.
- "LEO Pharma Buys Astellas' Dermatology Business for $725M - GEN". GEN. Retrieved 13 August 2018.
- "Astellas to Acquire Ganymed Pharmaceuticals for Up to $1.4B - GEN". GEN. Retrieved 13 August 2018.
- "Astellas to Buy GPCR Drugs Firm Ogeda for up to €800M - GEN". GEN. Retrieved 13 August 2018.
- "Astellas Acquires Mitobridge Under Existing Collaboration | Astellas Pharma Inc. GLOBAL WEBSITE". Astellas.com. Retrieved 2018-02-27.
- Megaw, Nicholas (June 23, 2017). "Drugmaker Astellas sanctioned for 'shocking' patient safety failures". Financial Times. United Kingdom. Retrieved June 23, 2017.
- Cohen, Deborah; Mulinari, Shai; Ozieranski, Piotr (2 July 2019). "The whistleblowing drama behind Astellas's suspension from the ABPI". BMJ: l4353. doi:10.1136/bmj.l4353.
- Helfand, Carly (June 23, 2017). "Astellas UK narrowly dodges expulsion after more trouble with Britain's pharma cops". FiercePharma. United States. Retrieved July 3, 2019.
- "AUTH/2984/10/17 - Health Professional v Astellas UK". PMCPA. Retrieved 3 July 2019.
- "Two Pharmaceutical Companies Agree to Pay a Total of Nearly $125 Million to Resolve Allegations That They Paid Kickbacks Through Copay Assistance Foundations". The United States Department of Justice (Press release). Retrieved 3 July 2019.
- "Flomax MR". The Chemist and Druggist (News in brief). Kent, England: CMP Information Ltd. 264 (6513): 12. 24 September 2005 – via Internet Archive.
- Richardson, Jennifer (17 November 2007). "Wholesale disbelief at Astellas sole supply deal". The Chemist and Druggist. Kent, England: CMP Medica. 268 (6622): 7 – via Internet Archive. A news brief appears the following week in the publication—"Astellas disappointment":
- "Astellas Pharma". The Chemist and Druggist (News brief). London, England: UBM Medica. 274 (6768): 10. 9 October 2010 – via Internet Archive.
- Slatko, Joshua (December 2013). "BMS changes senior management team". People on the Move: Pharma. Med Ad News. p. 27.
- "Corporate Philosophy of Astellas Pharma". Astellas Pharma. Retrieved September 9, 2014.