Just three months after splitting from Biogen, Bioverativ has inked its first major deal adding a new clinical candidate to its pipeline via a $825m deal to buy True North Therapeutics.
Bioverativ is paying $400m upfront for True North and its first-in-class candidate for cold agglutinin disease (CAD) – a rare and chronic haemolytic condition that can lead to severe anaemia – with another $425m in the offing if the drug hits milestone targets.
The complement C1 inhibitor TNT009 has been awarded breakthrough status by the FDA for CAD, which affects around 5,000 people in the US. Sufferers often have to undergo regular blood transfusions to control anaemia as well as frequent hospitalisations, and it can result in life-threatening clotting events including stroke.
The deal adds a clinical candidate to Bioverativ’s pipeline, which at the moment consists only of preclinical candidates although the company came into being with two already-marketed haemophilia therapies – Eloctate (efmoroctocog alfa) and Aprolix (eftrenonacog alfa).
TNT009 is currently in a phase Ia/Ib study for CAD and also has potential in other diseases, including warm autoimmune haemolytic anaemia, antibody-mediated rejection of transplants and bullus pemphigoid a rare skin disorder.
The acquisition is expected to be the first in a series of bolt-on deals designed to bolster Bioverativ’s haematology pipeline while it brings its in-house drugs through development. First among these home-grown candidates is BIV-001 for haemophilia which is due to start trials before the end of the year.
“This acquisition sits squarely with our vision to become the leading company in rare haematologic disorders,” said CEO John Cox on a conference call, describing it as “an exemplary first deal”.
The drug is given by intravenous infusion every two weeks, and in a proof-of-concept trial involving six CAD patients was shown to increase haemoglobin levels, suggesting the drug is reducing red blood cell destruction. All six patients were also transfusion-free while on treatment – which is “clinically meaningful”, said Cox.
The deal will be funded by a combination in cash and debt and is expected to close mid-year.