Shire has transferred its IND for the acute Graft-Versus-Host Disease (GvHD) treatment candidate Alpha-1 Antitrypsin (G1-AAT IV) to Kamada, which is overseeing development in Europe.
The transfer halts, for now, a Phase II/III study in the U.S. of G1-AAT IV that has seen a “slow recruitment rate” of patients. That was one of two reasons Kamada said it was given by Shire for the transfer, the other being that the biotech giant has other pipeline priorities.
Until now, Shire has led the G1-AAT IV GvHD program in the U.S., while Kamada has overseen the program in the European Union. Kamada said today it will take full ownership and responsibility for the clinical development of G1-AAT IV in GvHD.
“Kamada intends to resume the development program in the upcoming few months upon completion of standardizing the study design across both the U.S. and EU, based on the feedback already received from the FDA and the European Medicines Agency,” Kamada said in a statement.
Both agencies have previously granted Kamada their orphan drug designations for G1-AAT IV as a treatment for GvHD. In Europe, Kamada’s AAT is available to steroid-refractory acute GvHD patients in need on a named-patient basis through an Early Access Program that the company says is already enrolling patients.
“We believe that conducting an integrated clinical program across both territories will significantly benefit overall recruitment efforts, as well as provide important operational and financial efficiencies,” the company added.
Kamada inked exclusive supply, distribution, and license agreements for its IV AAT in 2010 with Baxter International, which three years later spun off its Baxter BioScience global biopharmaceutical business to create Baxalta. Last year Shire and Baxalta completed a $32 million merger, creating what it called the global market leader in rare diseases and other specialized disorders.
Shire is now the exclusive distributor of the IV AAT in the U.S., as well as Canada, Australia, and New Zealand.
Kamada said it continues to collaborate with Shire on clinical development of AAT IV for prevention of lung transplantation rejection. The initial agreement with Baxter focused on developing AAT as an emphysema treatment, and was extended twice by 2014, when the value of the agreement rose to up-to-$191 million.
As for GvHD, Kamada estimates that the rare disease represents a global $700 million market, and thus a “substantial” business opportunity for Kamada.
“We remain committed to the bone marrow transplant community and the GvHD patients, and look forward to continuing to advance the clinical development of G1-AAT IV with the objective of bringing to market a safe and efficacious product for this life-threatening disease,” the company added.