Alexion Pharmaceuticals

Summary

Alexion Pharmaceuticals, Inc.
TypeSubsidiary
Nasdaq: ALXN
IndustryPharmaceutical industry
Founded1992; 29 years ago (1992)
FounderLeonard Bell
Headquarters
Key people
Leonard Bell (Chairman)
Ludwig N. Hantson (CEO)
ProductsEculizumab (Soliris)
Ravulizumab (Ultomiris)
Asfotase alfa (Strensiq)
Sebelipase alfa (Kanuma)
Andexanet alfa (Andexxa)
RevenueIncrease US$6.069 billion (2020)
Decrease US$603 million (2020)
Total assetsIncrease US$18.103 billion (2020)
Total equityIncrease US$11.651 billion (2020)
Number of employees
2,525 (2020)
ParentAstraZeneca
Websitewww.alexion.com
Footnotes / references
[1]

Alexion Pharmaceuticals, a subsidiary of AstraZeneca, is an American pharmaceutical company headquartered in Boston, Massachusetts that specializes in orphan drugs to treat rare diseases.

Its products include eculizumab (Soliris) with $4.064 billion in 2020 revenues and ravulizumab (Ultomiris) with $1.076 billion in 2020 revenues, both used to treat the rare disorders of atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH); asfotase alfa (Strensiq) with $731 million in 2020 revenues, used to treat hypophosphatasia; sebelipase alfa (Kanuma) with $117 million in 2020 revenues, used to treat lysosomal acid lipase deficiency, and andexanet alfa (Andexxa) with $78 million in 2020 revenues, used to stop life threatening or uncontrollable bleeding in people who are taking rivaroxaban or apixaban.[1]

With costs that can reach as much as $2 million per year, the drugs manufactured by Alexion are some of the most expensive drugs worldwide.[2]

History

Alexion Pharmaceuticals was founded in 1992 at Science Park in New Haven, Connecticut by Steven Squinto and Leonard Bell, a physician at Yale New Haven Hospital and assistant professor of medicine and pathology at Yale School of Medicine.[3][4]

In 2000, Alexion moved its headquarters from New Haven to Cheshire, Connecticut.[5][6]

Alexion received U.S. Food and Drug Administration (FDA) approval for Soliris in 2007. It was initially approved to treat paroxysmal nocturnal hemoglobinuria, a rare blood disorder.[7]

In June 2010, there was an outbreak of hemolytic-uremic syndrome caused by Shigatoxigenic and verotoxigenic Escherichia coli (EHEC) in Germany. Soliris was tested as a treatment option because of its effectiveness in treating atypical hemolytic uremic syndrome, an illness similar to that caused by the EHEC infection.[8]

In January 2014, the company paid Moderna $100 million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform.[9] Although Moderna CEO Stéphane Bancel expected the platform to enter human trials in 2016, the program was scrapped in January 2017 after animal trials showed that Moderna's treatment would never be safe enough for humans.[10][11]

In April 2015, Bell was replaced as CEO by David Hallal.[12][13]

In 2016, the company became a member of the Pharmaceutical Research and Manufacturers of America (PhRMA).[14][15]

Alexion moved its headquarters back to New Haven following the completion of New Haven's Downtown Crossing project in February 2016.[16]

In December 2016, David Brennan became interim CEO. David Anderson, formerly the CFO of Honeywell, was appointed CFO, replacing Vikas Sinha.[17][18]

In March 2017, Alexion named Ludwig N. Hantson as its CEO.[19]

In September 2017, Alexion announced it would cut its workforce by 20% and move its headquarters to Boston, Massachusetts in mid-2018.[4][20] It also announced the closure of its manufacturing facility in Smithfield, Rhode Island.[21][22]

In July 2020, the company agreed to pay more than $21 million to settle claims that it bribed government officials in Turkey and Russia to gain approval for its drugs.[23][24]

In July 2021, AstraZeneca acquired the company.[25][26] Upon completion of merger, Alexion shareholders will own approximately 15% of combined company.The headquarters and operations would remain in boston.It would focus on rare diseases.[27][28]

Acquisitions

In September 2000, Alexion acquired Proliferon, a development-stage biopharmaceutical firm, for $41 million in stock. The company was renamed Alexion Antibody Technologies.[29]

In December 2011, Alexion acquired Montreal-based Enobia Pharma, the developer of asfotase alfa, a drug used to treat the genetic disorder hypophosphatasia, for as much as $1.08 billion.[30]

In June 2015, Alexion acquired Synageva, a maker of rare disease treatments, in an $8.4 billion stock-and-cash deal.[12][31][32][13][33][34]

In April 2018, Alexion announced the acquisition of Wilson Therapeutics for $855 million.[35][36]

In November 2018, the company acquired Syntimmune for $1.2 billion, expanding its rare disease offerings.[37][38][39]

In January 2020, the company acquired Achillion Pharmaceuticals for $930 million, boosting its immune system disease pipeline.[40][41][42]

In July 2020, Alexion acquired Portola Pharmaceuticals, diversifying its hematology, neurology, and critical care commercial portfolio with Portola's Factor Xa inhibitor reversal agent.[43][44]

Acquisition history

The following is an illustration of the company's mergers, acquisitions, corporate spin-offs and historical predecessors:

Alexion Pharmaceuticals
(Founded 1992)

Proliferon Inc
(Acq 2000, restructured into Alexion Antibody Technologies Inc)

Enobia Pharma Corp
(Acq 2011)

Synageva
(Acq 2015)

Wilson Therapeutics
(Acq 2018)

Syntimmune
(Acq 2018)

Achillion Pharmaceuticals
(Acq 2019)

Portola Pharmaceuticals
(Acq 2020)

Alexion Pharmaceuticals

Products

Alexion develops drugs to treat rare diseases. Pharmaceutical companies that produce drugs to treat rare diseases that afflict fewer than 10,000 people can charge very high prices for these drugs. They must also spread the cost of research and development over fewer patients since the drugs are not widely used.[45] Health insurance companies have generally been willing to pay the high prices for such drugs since the need for these drugs is very rare.[13]

Soliris

Alexion's first drug, Soliris (Eculizumab), launched in 2007,[3] used to treat atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).[3] It has been approved for use in Canada, the European Union, Japan, and the United States; however, availability in Canada is limited and is mostly through private clinics.[46]

In September 2011, the FDA approved the use of Soliris as a treatment for atypical hemolytic-uremic syndrome in both adults and children. More than half of people with aHUS die due to damage to vital organs/organ failure, usually involving the kidneys, caused by uncontrolled complement activation.[47]

In October 2017, the FDA approved the use of Soliris to treat adult patients with generalized myasthenia gravis (gMG).[48] In November 2017, the company received a patent for Soliris from the Japan Patent Office.[49]

Controversy due to high cost

With a list price of over $470,000 per year, Soliris is one of the most expensive drugs worldwide.[50][51][52][53][45][7][12] Alexion hires public relations firms to help people institute campaigns to pressure their governments to pay for the drug, which very few individuals can afford. Much of the research for the development of Soliris originates from publicly funded universities. There is an ethical question as to the pricing of the drug and the ethics of the drug manufacturer.[54]

In April and May 2013, a controversy arose in Belgium when the media revealed that the government had refused to pay for a seven-year-old boy's treatment because Soliris was too expensive. The boy's medicine cost €9,000 every two weeks.[55] A public relations agency working for Alexion had been reportedly looking for such a story and helped the boy's parents communicate their story to the press to pressure governments to reimburse the cost of the drug.[56][57][58] Several politicians stated that the company was attempting to 'blackmail' the government, charges which Alexion denied.[59] By May 7, 2013, an agreement had been reached for the government to reimburse the cost of the medicine beginning in July 2013.[60][61]

Strensiq

In October 2015, Alexion's second drug, Strensiq (asfotase alfa), was approved by the Food and Drug Administration. It is used to treat hypophosphatasia, a rare metabolic disorder.[62]

Kanuma

Kanuma, which Alexion acquired via its acquisition of Synageva, was approved in 2015 to treat lysosomal acid lipase deficiency, a fatal genetic disorder that cause fatty material to build up in blood vessel walls, the liver, and other tissues.[12]

References

  1. ^ a b "Alexion Pharmaceuticals 2020 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
  2. ^ Thomas, Katie; Abelson, Reed (August 25, 2019). "The $6 Million Drug Claim". The New York Times.
  3. ^ a b c Herper, Matthew (September 5, 2012). "How A $440,000 Drug Is Turning Alexion Into Biotech's New Innovation Powerhouse". Forbes.
  4. ^ a b SINGER, STEPHEN (September 12, 2017). "Alexion Exits New Haven For Boston, Agrees To Repay Millions In State Aid". Hartford Courant.
  5. ^ "Alexion Pharmaceuticals Moves Global Headquarters to New Haven". NBC News. June 19, 2012.
  6. ^ MACMILLAN, THOMAS (June 19, 2012). "Alexion Flees Cheshire For New Haven". New Haven Independent.
  7. ^ a b Seiffert, Don (May 6, 2015). "Everything you need to know about the $8.4B acquisition of Synageva". American City Business Journals.
  8. ^ Lang, Michelle (June 20, 2011). "Alexion tests treatment to respond to Germany's E. coli outbreak". American City Business Journals.
  9. ^ Reidy, Chris (January 13, 2014). "Alexion, Moderna announce agreement to develop messenger RNA therapeutics". The Boston Globe. Archived from the original on November 16, 2020.
  10. ^ Garade, Damien (September 13, 2016). "Ego, ambition, and turmoil: Inside one of biotech's most secretive startups". Stat. Archived from the original on November 16, 2020.
  11. ^ Garde, Damien (January 10, 2017). "Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine". Stat. Archived from the original on November 16, 2020.
  12. ^ a b c d Dulaney, Chelsey (May 6, 2015). "Alexion to Buy Synageva for $8.4 Billion". The Wall Street Journal.
  13. ^ a b c Cyran, Robert (May 6, 2015). "Alexion Puts Its Soaring Stock Price to Good Use". The New York Times.
  14. ^ Helfand, Carly (July 18, 2016). "Teva wins controversial PhRMA bid despite protests from branded rivals". FiercePharma.
  15. ^ "PhRMA Welcomes Five New Member Companies" (Press release). PR Newswire. July 15, 2016.
  16. ^ Hathaway, Bill (February 29, 2016). "Alexion homecoming is a symbol of biomedical growth in New Haven". Yale University.
  17. ^ "Alexion's Board of Directors Announces New Leadership Appointments" (Press release). Business Wire. December 12, 2016.
  18. ^ Rosen, Jon (December 12, 2016). "Alexion Pharmaceuticals announces new leadership appointments". WTNH.
  19. ^ Grover, Natalie (March 27, 2017). "Alexion Pharma names former Baxalta chief Ludwig Hantson CEO". Reuters.
  20. ^ Hufford, Austen; Rockoff, Jonathan D.; De Avila, Joseph (September 12, 2017). "Alexion to Cut Workforce by 20%, Shift Headquarters to Boston". The Wall Street Journal.
  21. ^ Bramson, Kate (September 12, 2017). "Drug maker Alexion to close R.I. plant". The Providence Journal.
  22. ^ Krause, Nancy (September 12, 2017). "Alexion closing RI manufacturing facility, 250 losing jobs". WPRI-TV.
  23. ^ Tokar, Dylan; Prang, Allison (July 2, 2020). "Alexion to Pay More Than $21 Million to Settle Bribery Claims". The Wall Street Journal.
  24. ^ "SEC Charges Alexion Pharmaceuticals With FCPA Violations" (Press release). U.S. Securities and Exchange Commission. July 2, 2020.
  25. ^ Higgins-Dunn, Noah (July 21, 2021). "AstraZeneca closes mega $39B Alexion buyout despite antitrust fears, making a splash in rare diseases". FiercePharma.
  26. ^ "Acquisition of Alexion completed" (Press release). AstraZeneca. July 21, 2021.
  27. ^ https://ir.alexion.com/news-releases/news-release-details/astrazeneca-acquire-alexion-accelerating-companys-strategic-and
  28. ^ https://www.nytimes.com/2020/12/12/business/dealbook/astrazeneca-alexion-deal.html
  29. ^ "BRIEFLY". Hartford Courant. September 27, 2000.
  30. ^ Finn, Ryan (December 29, 2011). "Alexion to Pay as Much as $1.08 Billion to Buy Enobia Pharma". Bloomberg News.
  31. ^ "Alexion Completes Acquisition of Synageva" (Press release). Business Wire. June 23, 2015.
  32. ^ Weisman, Robert (July 12, 2015). "How Genzyme became a source of biotech executives". The Boston Globe.
  33. ^ Seiffert, Don (June 23, 2015). "Alexion buys Lexington rare drug maker Synageva for $8.4B". American City Business Journals.
  34. ^ "Large Pharma Acquisition -- Alexion Buys Synageva for $8.4 Billion". IndustryWeek. Agence France-Presse. May 6, 2015.
  35. ^ Hirschler, Ben (April 11, 2018). "Biotech M&A rolls on as Alexion snaps up Wilson for $855 million". Reuters.
  36. ^ Arnott, Karen (April 11, 2018). "Alexion to Acquire Wilson Therapeutics for $855M". Mary Ann Liebert.
  37. ^ "Alexion Completes Acquisition of Syntimmune" (Press release). Business Wire. November 2, 2018.
  38. ^ "Alexion to Acquire Syntimmune for Up to $1.2B, Expanding Rare Disease Pipeline". Mary Ann Liebert. September 26, 2018.
  39. ^ Joseph, Saumya Sibi; Maddipatla, Manogna (September 26, 2018). "Alexion to buy biotech firm Syntimmune for up to $1.2 billion". Reuters.
  40. ^ "Alexion Completes Acquisition of Achillion" (Press release). Business Wire. January 28, 2020.
  41. ^ George, John (January 29, 2020). "$930 million sale of Blue Bell biopharma firm finalized". American City Business Journals.
  42. ^ Taylor, Nick Paul (October 16, 2019). "Alexion inks deal to acquire Achillion for $930M upfront". FierceBiotech.
  43. ^ "Alexion Completes Acquisition of Portola" (Press release). Business Wire. July 2, 2020.
  44. ^ DeAngelis, Allison (May 5, 2020). "Alexion pays $1.4B for Bay Area biotech in bid to double commercial portfolio". American City Business Journals.
  45. ^ a b Gallant, Jacques (December 4, 2014). "Toronto woman with rare disease fights province for life-saving but costly drug Soliris, which costs $500,000 a year, would treat Toni Vernon's blood disease, but the health ministry is holding back". Toronto Star.
  46. ^ "Alexion's Soliris® (eculizumab) Receives Marketing Approval in Canada for Patients with atypical HUS" (Press release). Cision. March 6, 2013.
  47. ^ "Soliris® (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)" (Press release). Business Wire. September 23, 2011.
  48. ^ Bruno, Giovanni (October 24, 2017). "Alexion Pharmaceuticals Stock Jumps on FDA Approval of Soliris". TheStreet.com.
  49. ^ "Alexion Receives New Japanese Patent for Soliris® (eculizumab), Extending Patent Protection Into 2027 and Strengthening Global Patent Portfolio" (Press release). Business Wire. November 6, 2017.
  50. ^ Higgins-Dunn, Noah (July 23, 2021). "Pharma AstraZeneca's newly acquired Soliris is overpriced in myasthenia gravis, cost watchdog says". FiercePharma.
  51. ^ Herper, Matthew (February 19, 2010). "The World's Most Expensive Drugs". Forbes.
  52. ^ Wall, Martin (February 5, 2015). "Doctors must tell patients of errors, under new Varadkar law". The Irish Times.
  53. ^ "High cost of treatment for rare blood disorder needs to be clarified, says NICE in draft guidance". National Institute for Health and Care Excellence. March 4, 2014.
  54. ^ Crowe, Kelly (June 25, 2015). "A Price to Pay: how the manufacturer pulls on emotions - patients, families, politicians and governments around the world". CBC News.
  55. ^ "Viktor (7) moet elke twee weken infuus krijgen van 9.000 euro" [Viktor (7) must receive an infusion of 9,000 euros every two weeks]. VRT (in Dutch). April 30, 2013.
  56. ^ Eckert, Maxie; Baumers, Koen (May 4, 2013). "Pr-bureau van farmabedrijf adviseerde ook ouders Viktor" [Pharmaceutical company's PR agency also advised parents Viktor]. De Standaard (in Dutch).
  57. ^ "Farmabedrijf Alexion heeft Viktor "gebruikt"" [Pharmaceutical company Alexion has "used" Viktor]. VRT (in Dutch). May 4, 2013.
  58. ^ "Farmabaas fluit Alexion terug in zaak-Viktor" [Pharma boss Alexion whistles back in Viktor case]. De Standaard (in Dutch). May 6, 2013.
  59. ^ "Detiège: "Dit is chantage van het farmabedrijf"" [Detiège: "This is blackmail from the pharmaceutical company"]. VRT (in Dutch). May 2, 2013.
  60. ^ "Medicijn Viktor vanaf juli terugbetaald" [Viktor medicine reimbursed from July]. De Standaard (in Dutch). May 7, 2013.
  61. ^ "Contract van Onkelinx met farmareus opent doos van Pandora" [Onkelinx contract with pharmaceutical giant opens Pandora's box]. De Morgen. March 23, 2015.
  62. ^ "FDA Approves Strensiq™ (asfotase alfa) for Treatment of Patients with Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia (HPP)" (Press release). Business Wire. October 23, 2015.

External links

  • Official website
    • Historical business data for Alexion Pharmaceuticals:
    • SEC filings