Shares of US biotech firm Bioverativ (Nasdaq: BIVV) fell 4% to 452.50 by close of trading on Tuesday, after it announced plans to acquire a privately held San Francisco-based rare disease drug developer,
Bioverativ, the stand-alone spin-out last August from biotech major Biogen (Nasdaq: BIIB) to focus on hemophilia, has signed a definitive agreement to acquire True North Therapeutics for an upfront payment of $400 million plus assumed cash. True North investors are also eligible to receive additional payments of up to $425 million contingent on the achievement of future development, regulatory and sales milestones.
As part of the acquisition, Bioverativ will obtain worldwide rights to True North’s lead candidate, TNT009, a first-in-class monoclonal antibody in development to treat cold agglutinin disease (CAD), a rare and chronic hemolytic condition that often leads to severe anemia, requiring numerous transfusions, and can result in life-threatening thrombotic events. There are no approved therapies for CAD, which occurs in approximately 16 people per million globally, including an estimated 5,000 people in the USA.
In May 2017, the US Food and Drug Administration granted TNT009 Breakthrough Therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development program, including a registrational program, are underway.
In line with rare diseases leadership goals
“One of our strategic priorities is to invest thoughtfully in business development with a focus on building our pipeline in areas where we believe we can make a real difference for patients,” said John Cox, chief executive of Bioverativ. “This acquisition of True North is aligned with those goals and with our vision to become the leading rare disease company focused on blood disorders. It strengthens our pipeline with a potential first-in-class therapy to treat CAD, a rare blood disorder with a high unmet patient need,” he added.
“Today’s announcement and TNT009’s breakthrough therapy designation are testaments to the innovative science underpinning our lead candidate and the strength of the True North team. We are delighted to have progressed our pipeline to this stage,” said Nancy Stagliano, CEO of True North, adding: “Bioverativ is well positioned to advance the development and commercialization of TNT009 on behalf of CAD patients who are greatly in need of safe and effective treatments.”
True North’s second molecule, TNT020, is a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less-frequent dosing and subcutaneous administration.
The acquisition will be financed through a combination of cash on hand and debt. It is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act of 1976 in the USA, and is expected to close in mid-2017.