Alexion's (ALXN) PNH Drug Ultomiris Shows Long-Term Efficacy
Alexion Pharmaceuticals ALXN announced positive, long-term data from the extension of the phase III study on Ultomiris and Soliris (eculizumab) in complement inhibitor-naïve, adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The data demonstrated that Ultomiris administered every eight weeks provided consistent efficacy and safety through 52 weeks, with no cases of breakthrough hemolysis (BTH) associated with incomplete C5 complement inhibition.
The data was presented at the Annual Congress of the European Hematology Association (EHA). Ultomirus was studied in the largest-ever phase III program in PNH.
Ultomiris demonstrated sustained efficacy on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels, and the secondary endpoints of LDH level reduction and breakthrough hemolysis (BTH). LDH level normalization and reduction are direct markers for reduced hemolysis in PNH.
All the patients in the initial Ultomirus group of the extension study maintained complete C5 inhibition through 52 weeks, and no patient experienced BTH associated with incomplete C5 inhibition. The data also showed that all patients, who had experienced incomplete C5 inhibition while receiving Soliris in the first 26 weeks, achieved complete C5 inhibition after the switch to Ultomiris in the extension phase.
Further, in an additional sub-study, nearly all patients preferred Ultomirs due to reduced infusion frequency, ability to plan activities, overall quality of life, convenience of treatment and effectiveness of medication until the next infusion compared to Soliris.
New results from the International PNH Registry will also be presented at the EHA congress.
Share price of Alexion has increased 21.9% year to date compared with the the industry’s growth of 1.8%.
We note that Ultomiris is approved by the FDA for the treatment of adult patients with PNH. The application for the drug in adults with PNH is currently under review in Europe and Japan.
Alexion Pharmaceuticals, Inc. Price
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Zacks Rank and Stocks to Consider
Alexion currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. ANIK, Applied Genetics Technologies Corp. AGTC and Acorda Therapeutics Inc. ACOR. All of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.
Acorda’s loss per share estimates have narrowed from $3.84 to $3.59 for 2019 and from $3.32 to $3.09 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 79.32%.
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