Novo Nordisk A/S NVO announced that Concizumab demonstrated a favorable safety profile and clinical proof of concept for the prevention of bleeding episodes in patients with hemophilia A (explorer5 study) and hemophilia A/B with inhibitors (explorer4 study).
Shares of Novo Nordisk have increased 10.5% year to date compared with the industry’s 5.4% growth.
The phase II studies (explorer5 and explorer4) showed annual bleeding rates comparable to factor prophylaxis despite many patients being undertreated due to conservative dosing rules. Treatment with concizumab was well tolerated, with no adverse event-related withdrawals and no thromboembolic events. The results from the studies support the drug’s use as a safe and well-tolerated subcutaneously administered prophylactic therapy in all patients with hemophilia.
Novo Nordisk expects to initiate a phase III study on concizumab later this year.
The company also announced two new interim analyses of the paradigm5 and paradigm6 children studies. Nonacog beta pegol (N9-GP, Refixia) demonstrated low annual bleeding rates and was well tolerated in children with hemophilia B, supporting the long-term safety and efficacy already established in previous studies. In the five-year interim analysis of paradigm5, bleeding rates in previously treated children (≤12 years) with hemophilia B were low and had declined after five years of treatment vs one year of treatment.
Refixia is an extended half-life factor IX molecule for replacement therapy in patients with hemophilia B.
The efficacy and safety profile of Refixia was further supported by the first interim results of ≥20 patients completing 50 exposure days (EDs) in paradigm6. Previously untreated children (<6 years) on weekly prophylaxis reported low bleeding rates and good bleed resolution with median annualised bleeding rates (ABRs) of 0.0 for overall, spontaneous and traumatic bleeds.
We remind investors that in February 2019, Novo Nordisk announced the FDA’s approval of its biologics license application (BLA) for Esperoct to treat adults and children with hemophilia A. In the United States, Esperoct is indicated for use in adults and minors with hemophilia A — using routine prophylaxis — to reduce bleeding episode frequency as well as on-demand for controlling bleeding episodes and the perioperative management of bleeding. In June 2019, the European Commission granted marketing authorization to Esperoct for the treatment of adolescents (≥12 years of age) and adults with hemophilia A.
Zacks Rank and Stocks to Consider
Novo Nordisk currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the large-cap pharmaceutical sector include Novartis AG NVS, Roche Holding AG RHHBY and Merck and Co., Inc. MRK. All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novartis’ earnings per share estimates increased from $4.98 to $5.01 for 2019 and from $5.48 to $5.56 for 2020 over the past 60 days. Share price of the company has increased 23% year to date.
Roche’s earnings per share estimates increased from $2.45 to $2.47 for 2019 and from $2.40 to $2.44 for 2020 over the past 60 days. Share price of the company has increased 11.4% year to date.
Merck’s earnings per share estimates have moved up from $4.72 to $4.74 for 2019 and from $5.23 to $5.28 for 2020 in the past 60 days. Share price of the company has increased 11.4% year to date.
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