Positive CHMP Opinion for Novo Nordisk's Drugs - Analyst Blog

Novo Nordisk NVO has a strong presence in the diabetes care market with one of the broadest diabetes portfolios in the industry.

Recently, Novo Nordisk gained a positive opinion in the EU from the Committee for Medicinal Products for Human Use (CHMP) for the expanded use of Tresiba and Victoza in type II diabetes. This recommendation will help doctors in achieving glycemic targets, especially in cases of concern about hypoglycemia and weight gain.

Victoza is a once-daily human glucagon-like peptide 1 (GLP-1) analogue approved for improving blood sugar (glucose) levels in adult type II diabetes patients. Victoza was launched in the EU in 2009 and is marketed in more than 65 countries worldwide. In 2013, Victoza revenues increased 23% y/y (27% in local currencies) to DKK 11.6 billion. Tresiba is an insulin analogue, approved in the EU (Jan 2013) and Japan (2012) for the treatment of type I and type II diabetes. However, the U.S. approval is yet to come.

Once it is approved by the European Commission, Tresiba can be prescribed in combination with Victoza. In the same way, Victoza can be prescribed in combination with Tresiba. The recommendation from the committee was based on data from four phase III studies, conducted in adults with type II diabetes. Pivotal data came from the BEGIN: VICTOZA ADD-ON 26-week study, which was supported by other studies including DUAL I, DUAL II and LIRA-DETEMIR study.

Novo Nordisk carries a Zacks Rank #3 (Hold). We are pleased with the positive opinion from the committee. We note that several big companies like Eli Lilly and Company LLY have a presence in the diabetes market.

Some better-ranked players include Alexion Pharmaceuticals, Inc. ALXN and Alkermes ALKS. Both stocks carry a Zacks Rank #1 (Strong Buy).