Astellas Pharma

"Astellas" redirects here. For similar sounding terms, see Astelia, Astellia, Astell, Astelma, and Astala.

Astellas Pharma Inc.

Company type	Public (K.K)
Traded as	TYO: 4503 TOPIX Core 30 Component TOPIX 100 Component Nikkei 225 Component
Industry	Pharmaceutical
Predecessors	Yamanouchi Pharmaceutical Fujisawa Pharmaceutical (Merged in 2005)
Founded	1 April 2005; 19 years ago (2005-04-01)
Headquarters	2-5-1, Nihonbashi-Honcho, Chūō-ku, Tokyo 103-8411, Japan
Key people	Naoki Okamura (President and CEO) Kenji Yasukawa (Chairman of the Board)
Products	Xtandi Padcev Xospata Vyloy Veozah Izervay Evrenzo Betanis Prograf and other pharmaceuticals
Revenue	US$11.418 billion [1] (2023)
Operating income	US$1 billion [1] (2023)
Net income	US$0.742 billion [1] (2023)
Total assets	US$18.47 billion [1] (2023)
Total equity	US$11.33 billion [1] (2023)
Number of employees	14,484[1] (2023)
Subsidiaries	Astellas US
Website	www.astellas.com/en/
Footnotes / references [1] [2][3][4]

Astellas Pharma office in Canada

Astellas Pharma Inc. (アステラス製薬株式会社, Asuterasu Seiyaku Kabushiki-gaisha) is a Japanese multinational 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).

Astellas is a member of the Mitsubishi UFJ Financial Group (MUFJ) keiretsu.

History

Early foundations

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.

Mergers and acquisitions

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.^[5] Astellas had a collaboration agreement with CoMentis from 2008 to 2014 focused on development of beta-secretase inhibitor therapeutics for Alzheimer's disease.^[6]

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.^[7]

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.^[8] In November 2015, the company announced its move to acquire Ocata Therapeutics (formerly Advanced Cell Technology) for $379 million.^[9] The deal was completed in February 2016.^[9][10] Later in November 2015 the company announced it would sell its dermatology business to LEO Pharma for $725 million.^[11] In October 2016 Astellas announced it would acquire Ganymed Pharmaceuticals for $1.4 billion^[12]

In March 2017, the company sold 16 of its drugs to LTL Pharma for ¥20.1 billion ($133 million).^[13] 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.^[14] 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.^[15]

In August 2018, Astellas announced it would acquire Quethera Limited for $109 million.^[16][17] In December 2018, the company announced it would acquire Potenza Therapeutics, Inc.^[18]

In December 2019, Astellas Pharma announced it would buy Audentes Therapeutics Inc for approximately $3 billion in cash^[19][20][21] as well as acquiring Xyphos Biosciences, Inc later in the same month.^[22][23] 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.^[24] The acquisition includes Astellas gaining Xyphos’ Advanced Cellular Control through Engineered Ligands (ACCEL) technology platform.^[25]

On February 5, 2020, the company announced management changes effective from April 1, 2020.^[26]

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.^[27]

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.^[28]

In May 2023, the business announced it would acquire Iveric Bio for $5.9 billion.^[29][30] 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.^[31][32]

Acquisition history

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

• Astellas Pharma
  • Fujisawa Pharmaceutical Co
    • Fujisawa Pharmaceutical Co (Est 1894)
    • Lyphomed (Acq 1990)
  • Yamanouchi Pharmaceutical Co (Est 1923)
  • OSI Pharmaceuticals (Acq 2010)
  • Ocata Therapeutics (Acq 2016)
  • Ganymed Pharmaceuticals (Acq 2016)
  • Ogeda (Acq 2017)
  • Mitobridge (Acq 2017)
  • Quethera Limited (Acq 2018)
  • Potenza Therapeutics, Inc. (Acq 2018)
  • Audentes Therapeutics Inc. (Acq 2019)
  • Xyphos Biosciences, Inc. (Acq 2019)
  • iota Biosciences, Inc. (Acq 2020)
  • Iveric Bio (Acq 2023)

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."^[33] In particular, Astellas had not fully disclosed the nature of a meeting which had purported to be a "genuine advisory board".^[34]

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.^[35]

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".^[34]

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".^[36] 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 kickbacks via Medicare copay foundations.^[37]

Business

Astellas' franchise areas are oncology, 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.

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.^[38]

Products

Some of the main 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
• 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
• 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^[39]
• 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.
• Padcev (enfortumab vedotin) - Bladder cancer
• 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
• Veozah (fezolinetant) - 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. 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.^[40][41]

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.^[42] 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.^[43]

Operations

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.^[44]

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.)^[45]

See also

• Zeria Pharmaceutical

References

1. "Astellas Pharma Financial Statements 2009-2024 | ALPMY". macrotrends.
2. "Corporate Profile". Astellas Pharma. Archived from the original on August 14, 2012. Retrieved September 9, 2014.
3. "Annual Report 2014" (PDF). Astellas Pharma. Archived from the original (PDF) on March 3, 2016. Retrieved September 9, 2014.
4. "Astellas Pharma Snapshot". Bloomberg Businessweek. Retrieved January 25, 2015.
5. "Yamanouchi Pimafucin (natamycin) product line manufactured at least up to 11/2007"
6. Staff (November 15, 2014). "Astellas Ends Alzehimer's Collaboration with CoMentis". Discovery & Development. Gen. Eng. Biotechnol. News (paper). Vol. 34, no. 20. p. 14.
7. Wilkinson, Emma (21 February 2009). "MHRA warns of dosing errors in immune drugs". The Chemist and Druggist. 271 (6686): 10 – via Internet Archive.
8. "Astellas, Cytokinetics Expand Muscle Drug Collaboration – GEN". GEN. 23 December 2014. Retrieved 13 August 2018.
9. "Astellas to Acquire Ocata Therapeutics for $379M – GEN". GEN. 10 November 2015. Retrieved 13 August 2018.
10. "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.
11. "LEO Pharma Buys Astellas' Dermatology Business for $725M – GEN". GEN. 12 November 2015. Retrieved 13 August 2018.
12. "Astellas to Acquire Ganymed Pharmaceuticals for Up to $1.4B – GEN". GEN. 28 October 2016. Retrieved 13 August 2018.
13. "Transfer of 16 Long-Listed Products in Japan" (PDF). Astellas. 28 March 2017. Retrieved 3 November 2023.
14. "Astellas to Buy GPCR Drugs Firm Ogeda for up to €800M – GEN". GEN. 3 April 2017. Retrieved 13 August 2018.
15. "Astellas Acquires Mitobridge Under Existing Collaboration | Astellas Pharma Inc. GLOBAL WEBSITE". Astellas.com. Retrieved 2018-02-27.
16. "Astellas Announces Acquisition of Quethera". BioSpace. Retrieved 2020-04-21.
17. "Astellas Expands Gene Therapy Investment, Acquires U.K.-based Quethera for $109 Million". BioSpace. 10 August 2018. Retrieved 2020-04-21.
18. "Astellas Acquires Potenza Therapeutics". BioSpace. Retrieved 2020-04-21.
19. "Astellas Buys Audentes for $3 Billion to Expand into Gene Therapy". BioSpace. 3 December 2019. Retrieved 2020-04-21.
20. "Japan's Astellas to buy Audentes for $3 billion in high-priced gene therapy bet". Reuters. 2019-12-03. Archived from the original on December 3, 2019. Retrieved 2020-04-21.
21. "Astellas Enters into Definitive Agreement to Acquire Audentes Therapeutics". www.businesswire.com. 2019-12-02. Retrieved 2019-12-16.
22. "Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc". BioSpace. Retrieved 2020-04-21.
23. "Astellas ramps up M&A, buys U.S. biotech Xyphos for as much as $665 million". Reuters. 2019-12-27. Archived from the original on December 27, 2019. Retrieved 2020-04-21.
24. "Astellas Completes Acquisition of Audentes Therapeutics". BioSpace. Retrieved 2020-03-04.
25. "Astellas has announced its acquisition of Xyphos for $665m". European Pharmaceutical Review. Retrieved 2020-02-25.
26. "Astellas Announces Management Structure". BioPortfolio. 12 March 2020. Retrieved 2020-04-02.
27. "Astellas' rheumatoid arthritis drug Smyraf wins regulatory nod – Korea Biomedical Review". www.koreabiomed.com (in Korean). 2020-01-30. Retrieved 2020-03-26.
28. "Astellas to Acquire iota Biosciences". 15 October 2020.
29. "Astellas to Buy Iveric Bio for $5.9B in Age-Related Blindness Play". May 2023.
30. Swift, Rocky (May 1, 2023). "Astellas Pharma buys Iveric Bio for $5.9 billion". Reuters.
31. "Astellas to Acquire Propella Therapeutics". 15 November 2023.
32. Priyan, Vishnu (16 November 2023). "Astellas agrees to take over Propella Therapeutics for $175m". Pharmaceutical Technology.
33. Megaw, Nicholas (June 23, 2017). "Drugmaker Astellas sanctioned for 'shocking' patient safety failures". Financial Times. United Kingdom. Archived from the original on December 11, 2022. Retrieved June 23, 2017.
34. Cohen, Deborah; Mulinari, Shai; Ozieranski, Piotr (2 July 2019). "The whistleblowing drama behind Astellas's suspension from the ABPI". BMJ. 366: l4353. doi:10.1136/bmj.l4353. PMID 31266743. S2CID 195788432.
35. 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.
36. "AUTH/2984/10/17 – Health Professional v Astellas UK". PMCPA. Retrieved 3 July 2019.
37. "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.
38. "Cancer-killing virus boosts immuno-oncology responses in mice in Astellas-led study". Fierce Biotech. 15 January 2020. Retrieved 2020-03-13.
39. "Flomax MR". The Chemist and Druggist (News in brief). 264 (6513). Kent, England: CMP Information Ltd.: 12 24 September 2005 – via Internet Archive.
40. "Astellas gains FDA priority review for gastric cancer therapy BLA". July 7, 2023.
41. "Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application". July 6, 2023.
42. Richardson, Jennifer (17 November 2007). "Wholesale disbelief at Astellas sole supply deal". The Chemist and Druggist. 268 (6622). Kent, England: CMP Medica: 7 – via Internet Archive.. A news brief appears the following week in the publication—"Astellas disappointment"
43. "Astellas Pharma". The Chemist and Druggist (News brief). 274 (6768). London, England: UBM Medica: 10. 9 October 2010 – via Internet Archive.
44. Slatko, Joshua (December 2013). "BMS changes senior management team". People on the Move: Pharma. Med Ad News. p. 27.
45. "Corporate Philosophy of Astellas Pharma". Astellas Pharma. Archived from the original on October 3, 2014. Retrieved September 9, 2014.

Further reading

• "One step ahead of manufacturers' tricky footwork". The Chemist and Druggist (Opinion). 264 (6520). Kent, England: CMP Information Ltd: 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). 2721 (6715). Kent, England: CMP Medica: 6. 12 September 2009 – via Internet Archive.

External links

• Official website