Shares of Alexion (ALXN ) jumped in pre-market trading after the company said its rare blood disorder drug was successful in a late-stage study.
WHAT’S NEW: The drug, ALXN1210, was being tested against another drug, Soliris, in a Phase 3 study in patients with paroxysmal nocturnal hemoglobinuria, or PNH. ALXN1210 was shown to be non-inferior to Soliris, achieving the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase, or LDH, levels, a direct marker of complement-mediated hemolysis in PNH. ALXN1210 also demonstrated non-inferiority to Soliris on all four key secondary endpoints. Detailed results will be submitted for presentation at a future medical conference, the company said, adding that it is planning regulatory submissions in the U.S., EU, and Japan in the second half of 2018.
EXECUTIVE COMMENTARY: “We are very pleased with these positive data for ALXN1210 in the first and only head-to-head study versus Soliris, and the results reinforce our ambition to establish ALXN1210 as the new standard of care for patients with PNH,” said John Orloff, EVP and Alexion’s head of research and development. Orloff added, “The data are also consistent with our hypothesis that immediate, complete, and sustained C5 inhibition is critical for patients with this potentially life-threatening disease… Soliris has established a high bar for efficacy. Achieving non-inferiority on both co-primary and all key secondary endpoints, as well as seeing numeric results in favor of ALXN1210, in such a rigorous study met a very high hurdle.”
PRICE ACTION: Alexion is up nearly 5% to $128.50 per share in pre-market trading.