CV Study Update on NVO's Victoza


Novo Nordisk (NVO) is conducting a cardiovascular (:CV) outcomes trial, LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results), aiming to assess and confirm the cardiovascular safety of Victoza. Results from the study should be out in 2016. Enrolment, which completed in Apr 2012, exceeded the original target by 586 patients.

We note that Victoza is a once-daily human GLP-1 analogue approved for improving blood sugar levels in adult type II diabetes patients. Revenues from Victoza were DKK 5.6 billion in the first half 2013, up 30% year over year (up 32% in local currencies). Victoza commanded a global market share of 69% in the GLP-1 segment at the end of May 2013 compared with 64% a year ago. Since Victoza’s launch, the GLP-1 market has expanded in the U.S.

Novo Nordisk has, in the meanwhile, completed all four trials under the SCALE phase IIIa study for Victoza 3 mg as a treatment for obesity. The company expects to file for approval in the U.S. and EU around the turn of the year.

Novo Nordisk has two more type II diabetes drugs – Tresiba and Ryzodeg – in its portfolio. While these drugs are approved in the EU and Japan, U.S. approval is yet to come. The FDA has asked Novo Nordisk to conduct a dedicated CV outcomes study for both Tresiba and Ryzodeg before it grants approval. Novo Nordisk expects to start the study later this year.

Many other companies have also conducted or are conducting cardiovascular outcomes study for diabetes drugs including Onglyza, Tradjenta, Lyxumia and Nesina.

Novo Nordisk currently carries a Zacks Rank #2 (Buy). Other large cap pharma stocks that look well-placed include Roche Holding (RHHBY), Eli Lilly and Company (LLY) and Bayer (BAYRY). Roche carries a Zacks Rank #1 (Strong Buy) while Bayer and Eli Lilly carry a Zacks Rank #2.

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