Alexion Pharmaceuticals

Alexion Pharmaceuticals is an American pharmaceutical company headquartered in Boston, Massachusetts that specializes in orphan drugs to treat rare diseases. It became an independent subsidiary of AstraZeneca in 2021.

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.

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.

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.

In 2000, Alexion moved its headquarters from New Haven to Cheshire, Connecticut.

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.

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.

In January 2014, the company paid Moderna $100million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform. 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.

In April 2015, Bell was replaced as CEO by David Hallal.

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

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

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

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

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

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.

In July 2021, AstraZeneca acquired the company.

Acquisitions

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

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.

In June 2015, Alexion acquired Synageva, a maker of rare disease treatments, in an $8.4 billion stock-and-cash deal.

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

In November 2018, the company acquired Syntimmune for $1.2 billion, expanding its rare disease offerings.

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

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

Acquisition history

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

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. Health insurance companies have generally not been willing to pay the high prices for such drugs since the need for these drugs is very rare.

Soliris

Alexion's first drug, Soliris (Eculizumab), launched in 2007, used to treat atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). 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.

In September 2011, the FDA approved the use of Soliris as a treatment for atypical hemolytic-uremic syndrome in both adults and children.

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

Controversy due to high cost

With a list price of over $470,000 per year, Soliris is one of the most expensive drugs worldwide. 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.

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. 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. Several politicians stated that the company was attempting to 'blackmail' the government, charges which Alexion denied. By May 7, 2013, an agreement had been reached for the government to reimburse the cost of the medicine beginning in July 2013.

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.

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.

References

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Pharmaceutical companies of the United States
Companies based in Boston
Companies formerly listed on the Nasdaq
Health care companies based in Massachusetts
Pharmaceutical companies established in 1992
Orphan drug companies
Life sciences industry
Specialty drugs
American companies established in 1992
1992 establishments in Connecticut
1996 initial public offerings
2021 mergers and acquisitions
AstraZeneca
American subsidiaries of foreign companies