In an agreement expected to exceed $100 million, Medexus Pharmaceuticals has bought global commercial rights to Ixinity, an approved recombinant factor IX therapy for hemophilia B previously marketed by Aptevo Therapeutics.
Sale terms include an upfront $30 million payment, plus up to $11 million in prospective milestone payments based on certain regulatory and commercial achievements. In addition, Aptevo will get deferred payments estimated to exceed $60 million on future U.S. and Canadian net sales of Ixinity for up to 15 years.
“We are very pleased to announce this transformative acquisition,” Ken d’Entremont, chief executive officer of Medexus, said in a press release. “Ixinity is an FDA-approved product with strong brand equity and a track record of safety, efficacy and growing sales.”
Developed by Aptevo, Ixinity is approved in the U.S. to replace the clotting factor IX (FIX) missing in adults and children with hemophilia B ages 12 and older. Hemophilia B can cause prolonged bleeding after surgery or an injury. In severe cases, spontaneous bleeding can occur even without an injury.
An injected treatment, Ixinity replenishes FIX levels and restores the normal blood-clotting process. It’s recommended for the control and prevention of bleeding episodes, as well as to manage blood loss during surgery.
A larger, 3,000 international unit Ixinity vial was introduced last year.
Aptevo recently announced the dosing of the first patient enrolled in an ongoing, open-label Phase 4 trial (NCT03855280) seeking to extend Ixinity’s use as a preventive treatment to children with hemophilia B younger than 12.
The study is designed to assess the safety, efficacy, and pharmacokinetics of prophylactic treatment with Ixinity in 22 previously treated children with moderate to severe hemophilia B. The three-part trial aims to collect data on two groups — participants under 6 years old, and those ages 6 to 12. The study is recruiting patients in Moldova, Ukraine and South Africa; more information is available here.
Pooled data from previous trials, including an open-label Phase 3 study (NCT01271868), coverage 12 children with hemophilia B up to age 12, suggested the therapy was safe and well-tolerated, and may be an effective treatment for pediatric patients.
Statistics indicate that roughly 33% of all those with hemophilia B in the U.S. are under age 13. A pediatric label extension could markedly increase those able to be treated with Ixinity.
The therapy claimed $23.4 million in revenues over the first nine months of 2019, a 40% year-over-year increase, Medexus reported in its release, adding that the U.S. hemophilia market is about $734 million and growing.
Utilizing its Adaptir bispecific platform, Aptevo, a Washington-based biotechnology company, is focused on developing oncology, autoimmune, and hematology therapeutics. This sale sharpens that focus.
“Our divestiture of Ixinity represents a transformative event for Aptevo,” Marvin L. White, president and chief executive officer of Aptevo, said in a press release.
“With a stronger balance sheet and potential future milestone and deferred payments from Ixinity; a promising and productive technology engine — our Adaptir platform, and a streamlined focus, Aptevo is well-positioned to advance its core assets towards value-creating milestones,” White said.
Medexus is a specialty pharmaceutical company focused on rheumatology, autoimmune disease, oncology, allergy, and pediatric diseases.
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