Bioverativ—the developer of drugs for rare blood disorders spun out of Biogen earlier this year—said today it plans to acquire True North Therapeutics for up to $825 million, in a deal designed to strengthen the buyer’s pipeline.
The deal will give Bioverativ global rights to True North’s lead candidate TNT009, a first-in-class monoclonal antibody being developed as a treatment for cold agglutinin disease (CAD).
TNT009 is designed to selectively inhibit the classical complement pathway by targeting C1s, a serine protease within the C1 complex in the complement pathway of the immune system, and directly impacting the central mechanism of CAD—while maintaining activity of the alternative complement pathway and lectin complement pathway, which are important for immune surveillance and other functions.
There are no approved therapies for CAD, which occurs in an estimated 5000 people in the U.S. and approximately 16 people per million globally.
Earlier this month, TNT009 received the FDA’s breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD. The FDA based its decision on data from a Phase Ib trial that showed that TNT009 normalized hemoglobin levels in all six study participants with primary CAD, increasing hemoglobin by an average of 4 g/dL and resolving their anemia. All participants were transfusion free while on treatment.
TNT009 has received orphan drug designation from the FDA and the European Medicines Agency. According to the companies, plans for a full clinical development program, including a registrational program, are underway.
“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,” added True North CEO Nancy Stagliano, Ph.D.
Also in True North’s pipeline is its second molecule, TNT020, a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less-frequent dosing and subcutaneous administration.
Bioverativ is the former global hemophilia business of Biogen that was spun out in January, when it began trading its shares on the NASDAQ Global Select Market. The company focuses on R&D and commercialization of new therapies designed to address areas of serious unmet need in hemophilia and other rare blood disorders.
“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,” Bioverativ CEO John Cox said in a statement. “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.”
Cox added that the acquisition would be consistent with Bioverativ’s capital allocation philosophy: “We expect it to create significant value for our shareholders over the long term.”
Bioverativ agreed to shell out $400 million upfront for privately-held True North, plus up to $425 million in payments tied to achieving development, regulatory, and sales milestones.
Bioverativ said the acquisition will be financed through a combination of cash on hand and debt. The deal 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 U.S., and is expected to close in mid 2017.