Kamada Provides Update on Clinical Program for Alpha-1 Antitrypsin IV for Treatment of Graft-Versus-Host Disease
REHOVOT, Israel, June 07, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (KMDA) (KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced that Kamada and Shire have agreed that the Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA) for the Phase 2/3 study evaluating Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (GvHD) will be transferred from Shire to Kamada, who will take full ownership and responsibility for the clinical development of the product in this indication. Shire has been leading the G1-AAT IV GvHD program in the U.S., while Kamada is leading the program in the European Union (EU). Shire decided to transfer the IND to Kamada due to pipeline prioritization and slow recruitment rate in its current U.S. study. Kamada will assume control of, and onward funding for the full G1-AAT IV program, and intends to conduct an integrated clinical development program across both territories - the U.S. and the EU.
As the result of this decision, the current Part 1 of the Phase 2/3 study conducted in the U.S. is being halted by Shire. 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 (EMA). Kamada previously received Orphan Drug Designation from the FDA and EMA for G1-AAT IV for the treatment of GvHD.
“Kamada is excited to lead this promising development program globally,” said Amir London, Kamada’s Chief Executive Officer. “Based on the FDA-approved IND in the U.S. and the guidance received at our Scientific Advice meeting held earlier this year with the EMA, we have a clear understanding of the regulatory path forward in both territories. Moreover, based on our GvHD industry expertise and discussions held with the Key Opinion Leaders (KOLs), from both territories, who strongly support us in this program, 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. According to our estimates, GvHD is a $700 million market globally and, therefore, represents 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.”
Kamada’s AAT is currently available to steroid-refractory acute GvHD patients in need on a named-patient basis through an Early Access Program in Europe. The program is already enrolling patients.
Kamada and Shire (Baxter at the time) entered into strategic cooperation agreements, including exclusive supply, distribution, and license agreements for the distribution and license of Kamada’s IV AAT, in 2010. Under the terms of the agreements, Shire is the exclusive distributor of the product in the U.S., Canada, Australia and New Zealand. In addition, Kamada and Shire continue to collaborate on the clinical development of AAT IV for prevention of lung transplantation rejection.
