AstraZeneca has agreed to acquire Alexion Pharmaceuticals, a Boston-based biopharmaceutical company focused on rare diseases, for $39 billion.

The acquisition would position AstraZeneca in immunology and the development of medicines for immune-mediated diseases. Alexion is focused on complement inhibition for immune-mediated rare diseases that are caused by uncontrolled activation of the complement system, part of the immune system. The complement system plays an important role in many inflammatory and autoimmune diseases across multiple therapy areas, including hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care.

Alexion posted 2019 net product sales of $4.99 billion, of which its lead product, Soliris (eculizumab), a drug to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, and other rare blood diseases and autoimmune diseases, accounted for 79% of sales, or $3.95 billion. Soliris faces near-term biosimilar competition, and its successor product, Ultomiris (ravulizumab), which was approved by the US Food and Drug Administration in 2018 to treat PNH, posted 2019 net sales of $338.9 million. Another key product, Strensiq (asfotase alfa), a drug to treat perinatal/infantile- and juvenile-onset hypophosphatasia, a rare genetic disorder characterized by the abnormal development of bones and teeth, had 2019 net sales of $592.5 million.

Soliris is an anti-complement component 5 (C5) monoclonal antibody and in addition to PNH, it is approved for treating: atypical hemolytic uremic syndrome, a disease that causes abnormal blood clots to form in small blood vessels in the kidney; generalized myasthenia gravis, a chronic autoimmune neuromuscular disease; and neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system. Ultomiris is a second-generation C5 monoclonal antibody with a more convenient dosing regimen than Soliris. In addition to PNH, it is approved for treating atypical memolytic uremic syndrome.

Alexion’s pipeline consists of 11 molecules across more than 20 clinical-development programs for indications in rare diseases and other areas. Alexion completed two acquisitions this year (2020) to add to its commercial portfolio and pipeline. In June (June 2020), Alexion completed its $1.4-billion acquisition of Portola Pharmaceuticals, a South San Francisco-based commercial-stage biopharmaceutical company focused on rare diseases. Portola’s lead commercial product is Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], a Factor Xa inhibitor reversal agent, which reverses the anticoagulant effects of Factor Xa inhibitors, rivaroxaban and apixaban, in severe and uncontrolled bleeding. In January (January 2020), it completed its $930-million acquisition of Achillion Pharmaceuticals, a Blue Bell, Pennsylvania-based clinical-stage biopharmaceutical company focused on developing oral small-molecule Factor D inhibitors for certain rare diseases.

Under the agreement, Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares for each Alexion share for a total consideration to Alexion shareholders of $39 billion or $175 per share. The boards of directors of both companies have unanimously approved the acquisition.

Subject to receipt of regulatory clearances and approval by shareholders of both companies, the acquisition is expected to close in the third quarter of 2021. Upon completion, Alexion shareholders will own approximately 15% of the combined company. With the closing of the deal, AstraZeneca intends to establish Boston, Alexion’s current headquarters, as its headquarters for rare diseases.

Source: AstraZeneca and Alexion Pharmaceuticals