Shares of Novo Nordisk A/S NVO have rallied 23.4% in the past year compared with the industry’s growth of 14.9%.
Novo Nordisk has a strong presence in the Diabetes care market, with a global value share of 28.4%. The company has one of the broadest diabetes portfolios in the industry. The top line is driven by the strong performance of products such as Victoza (liraglutide).
In September 2019, the FDA approved semaglutide in tablet form, which will be marketed under the brand name Rybelsus. It is approved as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. It is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet form. The drug is also under review with several regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
Additionally, the company is making efforts to develop new treatments for diabetes, which is its core area of expertise.
In February 2019, the FDA approved Novo Nordisk’s biologics license application (BLA) for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of hemophilia A in adults and children. The drug is approved for routine prophylactic to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes plus perioperative management of bleeding in the given patient population. In July, the European Commission granted marketing authorization to the drug for the treatment of adolescents (≥12 years of age) and adults with hemophilia A.
In July 2019, the first human dose trial with LA-GDF15 was initiated, including both single and multiple ascending doses. Human GDF15 (Growth Differentiation Factor 15, also known as MIC-1) is a stress-induced cytokine with multiple effects, one being appetite regulation leading to weight loss. LA-GDF15 is a long-acting version of human GDF15. During the same time, Gilead Sciences GILD and Novo Nordisk initiated a phase II proof-of-concept study combining semaglutide and the former’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with nonalcoholic steatohepatitis (NASH).
The company has also been on track with acquisitions in order to boost its portfolio. In November 2019, Novo Nordisk and UBE Industries Ltd. announced that the former obtained an exclusive worldwide license to UBE’s preclinical asset UD-014, a selective Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) inhibitor small molecule, which has shown promising efficacy in preclinical studies for its anti-inflammatory mechanism of action and antioxidative effect on endothelial cells, and can potentially be used for the treatment of non-alcoholic steatohepatitis (NASH).
In October 2019, Novo Nordisk and bluebird BLUE inked a three-year research collaboration to jointly develop next-generation vivo genome editing treatments for genetic diseases, including hemophilia. Per the agreement, both companies will focus on identifying a development gene-therapy candidate to offer people with hemophilia A a lifetime free of factor replacement therapy.
However, Novo Nordisk faces competition as the diabetes market is already crowded with a number of drugs. Merck’s MRK Januvia and Janumet (type II diabetes), Eli Lilly’s Trulicity (type II diabetes), Sanofi’s Toujeo (type I and II diabetes) are already approved.
Novo Nordisk currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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