Novo Nordisk and Mylan Battle Over Generic Versions of Victoza
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Denmark’s Novo Nordisk filed a lawsuit in a Delaware district court against generic drugmaker Mylan. The suit is an attempt to block Mylan from marketing a generic version of Novo Nordisk’s diabetes drug Victoza (liraglutide).
In 2018, Victoza had U.S. sales of $2.7 billion, accounting for 16.2% of the company’s revenue. Patents expire in July 2021, December 2022, February and December 2023, November 2024, February 2026 and March 2033.
On June 17, the U.S. Food and Drug Administration (FDA) approved Victoza injection to lower blood glucose levels along with diet and exercise in children and adolescents aged 10 to 17 years with type 2 diabetes. The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist, the first to be approved for this age group.
Victoza was first approved in the U.S. in 2010 in adults with type 2 diabetes. The new approval was based on data from the global ELLIPSE Phase III clinical trial. In the study, patients aged 10 to 17 were randomized to receive Victoza up to 1.8 mg per day or placebo in combination with metformin with or without basal insulin for a 26-week double-blind period followed by a 26-week open-label extension period.
“We are delighted with the label expansion for Victoza, which now includes an indication for use in children and adolescents with type 2 diabetes in the U.S.—this is a landmark approval as the first-ever GLP-1 receptor agonist approved for this population,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The prevalence of type 2 diabetes in the U.S. is ever increasing and we are seeing a higher number of diagnoses in children and adolescents, for whom there are limited treatment choices. Victoza will provide a new option for clinicians treating this challenging disease, helping to address the growing need for this population.”
Novo Nordisk reported increased operating profit of 12% in Danish kroner and 6% in constant exchange rates (CER) in the first six months of 2019 at its recent quarterly report. Sales overall increased by 9% in Danish kroner and 5% at CER to $9 billion (US). Within its diabetes and obesity area, sales grew 10% to $7.6 billion (US), driven by the diabetes division, which grew 4% (CER) and obesity growing 56% (CER). The biopharmaceuticals division increased by 7% to $1.4 billion (US).
Although Victoza is certainly a big factor in the company’s success, it has another GLP-1 agonist, Ozempic (semaglutide), which is growing significantly. Sales for the first half of the year were $568 million. It is now being marketed in 21 countries. Its new-to-brand prescription market share in the U.S. is now 335%, bringing its combined GLP-1 new-to-brand prescription market share to 53%.
“We are pleased with the sales growth in the first half of 2019, which is driven by all regions in International Operations,” stated Lars Fruergaard Jorgensen, president and chief executive officer of Novo Nordisk. “The launch of Ozempic is expanding the GLP-1 market, and we are encouraged by the positive market reception in both North America and Europe. With the initiation of four major late-stage clinical trials, we continue to investigate the clinical benefits of semaglutide across multiple indications. The solid financial performance in the first half of 2019 has enabled us to raise our outlook for the full-year.”