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Blood Disorder Drug Maker Acquired in $11.6B Deal

Drop of blood on finger

(Alden Chadwick, Wikimedia Commons)

22 January 2018. The global pharmaceutical company Sanofi is buying Bioverativ Inc., a developer of biologics to treat hemophilia and other rare blood disorders. The agreement for Paris-based Sanofi to acquire Bioverativ, in Waltham, Massachusetts, is valued at $11.6 billion.

Bioverativ is a spin-off enterprise from the biopharmaceutical company Biogen, founded in 2016. The company has two biologic therapies already approved to treat hemophilia A and B, Eloctate and Alprolix, respectively. Hemophilia is an inherited disorder, where a genetic defect causes the proteins needed to mix with platelets allowing blood to coagulate are missing. About 8 in 10 people with the condition have hemophilia type A, where the protein clotting factor 8 is missing. In type B, clotting factor 9 is missing. Factor 9 is made in the liver, and circulates dormant in the blood stream until a blood vessel is damaged, when it is activated by other proteins that set in motion the processes to form a clot.

Eloctate is a synthetic protein that joins clotting factor 8, missing in people with hemophilia A, to a part of immunoglobulin G antibodies to extend the time Eloctate works in the body. Likewise, Alprolix fuses with clotting factor 9, needed by people with hemophilia B, to extend the therapy’s working activity time. Both biologics, says Bioverativ, are derived from human cell lines.

The company’s pipeline also has a treatment in late-stage clinical trials for cold agglutinin disease, a rare form of anemia where the immune system mistakenly attacks red blood cells. Bioverativ gained the technology for this therapy in 2016, when it acquired another biotechnology enterprise, True North Therapeutics. The biologic, code-named BIVV009, is a synthetic antibody that received orphan drug status from regulatory authorities in the U.S. and Europe.

Bioverativ is also developing with Sangamo Therapeutics a treatment using genome editing for inherited blood disorders sickle cell disease and beta thalassemia. Sangamo’s technology adapts an earlier form of genome editing known as  zinc-finger nucleases, where synthetic enzymes modify DNA sequences, including corrections or insertions. Sangamo says it engineers the proteins to predictably and consistently bind with longer DNA sequences for a range of inherited diseases.

In the merger deal, Sanofi is acquiring all outstanding shares of Bioverativ stock for $105 a share, for a total cost of $11.6 billion. That price is 64 percent higher than Bioverativ’s closing share price on 19 January. Sanofi is using its cash on hand and taking on new debt to raise the purchase funds.

Sanofi is creating another treatment for hemophilia called fitusiran that uses RNA interference to silence aberrant genes preventing production of the missing clotting factors. Fitusiran, developed in partnership with biotechnology company Alnylam, has a somewhat troubled history. In September 2017, FDA ordered Alnylam to suspend its intermediate- and late-stage clinical trial of fitusiran, when one of the trial’s participants died. FDA lifted the hold in December, allowing the trial to resume.

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