ROXADUSTAT PRESENTS A NEW OPPORTUNITY FOR TRIFERIC
New anemia drug expected to transform treatment & change iron requirements for dialysis patients Roxadustat is a new approach to treatment of the anemia of CKD •A physiologic approach to anemia mgmt. with improved safety vs. ESA’s* • Expected approval in Q1 2021
Roxadustat patients will require less iron •Reduces hepcidin & increases iron binding capacity (circulating transferrin), improving bioavailability of body iron stores & reducing requirement for IV iron supplementation • Evidence presented at ASN 2020 shows a monthly iron requirement of ~52mg
Triferic may be uniquely suited to meet iron requirements of HIF-PHI patients
•Triferic provides 100% bioavailable iron, bypassing hepcidin block and donating directly to transferrin •Triferic in the dialysate alone (84mg per month) may be sufficient to meet iron needs of most roxadustat treated patients eli min ating the need for I.V. iron supplementation
Rockwell planning on conducting Triferic Phase 4 study for adjunctive use with roxadustat •To be initiated after FDA approval of roxadustat
TRIFERIC : INTERNATIONAL MARKET
China •Partnered to commercialize Triferic with Wanbang Biopharmaceutical •Registrational study started treating patients in Jan’21 •Low to mid 20% royalty due to Rockwell on Net Sales; $35 million potential milestone payments
India •Signed licensing agreement with Sun Pharma in January 2020 • NDA submitted
LATAM •Distribution agreements in place and commercial launch in Peru and Chile expected Q1 2022
Canada •Distribution agreement in place; NDS submitted in May 2020 and accepted for filing in June 2020
S.Korea •Signed licensing agreement with Jeil Pharma in September 2020 •Jeil Pharma submitted NDAs for both Triferic and Triferic AVNU in January 2021.
Europe / Japan •Discussions ongoing with potential partners for Triferic AVNU