Novartis Presents Positive Data on Sickle Cell Disease Drug
Novartis AG NVS announced positive results from a post hoc analysis of the phase II study, SUSTAIN, on pipeline candidate, crizanlizumab.
The mid-stage trial was a multicenter, multinational, randomized, placebo-controlled, double-blind,12-month study to assess safety and efficacy of the anti-P-selectin antibody, crizanlizumab, with or without concomitant use of hydroxyurea therapy in sickle cell disease (SCD) patients with sickle cell-related pain crises.
The post hoc analysis reviewed 52-week results from 132 patients, including 67 treated with crizanlizumab 5 mg/kg and 65 with placebo.
The results were published in the American Journal of Hematology. The study results showed that more than twice as many patients taking crizanlizumab did not experience a disease-related pain crisis (also called vaso-occlusive crisis, or VOC) as compared to placebo.
Patients treated with crizanlizumab (35.8%) did not experience a VOC as compared to those treated with placebo (16.9%).
Adverse events were similar in both arms. Novartis will discuss the results with health authorities and a filing in the United States is expected in 2019.
Approval of new drugs bode well for Novartis. The company has a strong oncology portfolio, including drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu and Kisqali, which continue to boost sales. However, it is facing the loss of patent protection for some of the key drugs.
Consequently, the company has restructured its business and plans to focus on building its portfolio in potential markets. The company’s shares have gained 5.8% in the year so far, against the industry’s growth of 10.1%.
Of late, Novartis is redirecting its focus to its core areas of growth. Earlier, the company announced that it intends to spin-off its ophthalmology division, Alcon, into a separately-traded standalone company to grow as a medicines company solely.
The Alcon business wasn’t performing as per management’s expectations. Although it did revive in between, the company decided to spin-off the same in order to focus better on its legacy drug business. The company also exited its antibacterial business. Earlier, Novartis also divested its stake in the OTC joint venture with GlaxoSmithKline GSK for $13 billion.
Novartis is looking to solidify its presence in the gene-therapy space. Earlier, it acquired U.S.-based clinical stage gene-therapy company, AveXis, Inc. It announced a licensing agreement with Spark Therapeutics ONCE, covering development, registration and commercialization rights to voretigene neparvovec, outside the United States.
Zacks Rank & Stock to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
A better-ranked large-cap drug stock is Bristol-Myers Squibb Company BMY, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates increased to $3.63 from $3.59 for 2018 and to $3.94 from $3.83 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.39%.
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