Novo Nordisk's Haemophilia A Drug Esperoct Gets EU Approval

Novo Nordisk (CSE:NOVOb) A/S (NYSE:NVO) announced that the European Commission has granted marketing authorization for Esperoct for the treatment of adolescents (≥12 years of age) and adults with haemophilia A. The authorization covers all 28 European Union member states. Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.

Esperoct is the brand name for turoctocog alfa pegol, N8-GP. The efficacy and safety evaluation was based on the results from the largest pre-registration clinical program conducted in haemophilia A, with inclusion of 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure.

Esperoct has been found effective in treating severe haemophilia A through a simple fixed dosing regimen of one injection every four days in adults and adolescents or every 3-4 days (twice-weekly) in children. The drug is also found to be effective in controlling bleeding episodes and perioperative management with no acute safety concerns.

The marketing authorization for the use of Esperoct treads on the heels of the positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in April 2019.

Shares of Novo Nordisk have increased 12.2% year to date compared with the industry’s 7.8% growth.

In February 2019, Novo Nordisk announced the FDA’s approval of its biologics license application (BLA) for Esperoct to treat adults and children with haemophilia A. In the United States, Esperoct is indicated for use in adults and minors with haemophilia A — using routine prophylaxis — to reduce bleeding episode frequency as well as on-demand for controlling bleeding episodes and the perioperative management of bleeding.

The marketing authorization for Esperoct in Europe will further lead to increased sales of the drug.

The company is making efforts to develop new treatments for diabetes, which is its core area of expertise. In January 2019, Novo Nordisk initiated a phase I study on LAIsema, the combination of once-weekly insulin LAI287 and once-weekly injectable GLP-1 semaglutide. The study will investigate single-dose pharmacokinetics of LAIsema in a fixed ratio compared with LAI287 and semaglutide given separately to people with type II diabetes.

In November 2018, Novo Nordisk completed the extension phase of REAL 3, the phase II study with long-acting recombinant growth hormone, somapacitan (NN8640) for treatment of growth hormone deficiency (GHD). The company is preparing for the pivotal phase III somapacitan programs in children with GHD and a phase II study in children born small for gestational age (SGA).

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 AbbVie Inc. (NYSE:ABBV) , Novartis AG (NYSE:NVS) and Merck and Co., Inc. (NYSE:MRK) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie’s earnings per share estimates increased from $8.68 to $8.81 for 2019 and from $9.25 to $9.38 for 2020 over the past 60 days. The company surpassed estimates in three of the trailing four quarters, with average positive surprise of 2.58%.

Novartis’ earnings per share estimates increased from $4.90 to $5.01 for 2019 and from $5.50 to $5.56 for 2020 over the past 60 days.

Merck’s earnings per share estimates have moved up from $4.65 to $4.73 for 2019 and from $5.19 to $5.21 for 2020 in the past 60 days. The company beat estimates in the trailing four quarters, with the average being 5.67%.

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