Victoza - Novo Nordisk

Victoza (liraglutide)
Novo Nordisk
Launch Date: February 2010 (U.S.), July 2009 (EU)
First-Year Sales (2010): 2.3 billion kroner (about $418 million)
First-Half 2013 Sales: 5.555 billion kroner (about $1 billion)
Analyst Estimate for 2018: $4.07 billion

Over Victoza's short history, earnings headlines have featured one impressive growth stat after another. Last year, the diabetes drug's sales prompted Novo Nordisk ($NVO) to hike its financial forecasts not once but twice. And that's after it more than doubled sales in 2011, to 5.99 billion kroner, or about $1.04 billion at the time--just past the blockbuster threshold. It was the drug's first full year on the market in the U.S.

Victoza is a GLP-1 agonist, competing directly with Byetta and Bydureon from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN), and with Merck's ($MRK) DPP-4 inhibitor Januvia (and to a lesser extent, Onglyza, from BMS and AZ, and Tradjenta from Eli Lilly). Novo has put serious money behind studies comparing Victoza with several of its rivals, and, luckily for the company, Victoza has come out on top.

Victoza ended 2012 at 9.5 billion kroner (about $1.7 billion), only about two-thirds more than the previous year. So, growth has slowed somewhat. It slowed further this year, with first-half sales at 5.56 billion kroner, about $979 million at the time. That was 30% growth year over year.

Part of the reason that Victoza has continued to churn up growth for Novo is that the Danish drugmaker expanded its U.S. sales force last year, in anticipation of winning FDA approval for its latest diabetes fighter, Tresiba. But that approval wasn't forthcoming, so the new staff went to work promoting Victoza and Novo's modern insulin products. That, in turn, helped Victoza grow its market share to 65% in the GLP-1 field.

Until last month, that is. The company lost a big Victoza contract with the pharmacy benefits manager Express Scripts to GLP-1 rivals Byetta and Bydureon. Analysts estimate that the PBM's business accounted for 15% to 20% of Victoza's U.S. sales. That could put a $100-million-plus dent into 2014 results.

Meanwhile, Sanofi ($SNY) won approval for Lyxumia, another GLP-1 drug, which is taking aim at Victoza. Longer term worries include Lilly's experimental drug dulaglutide, which could win approval by 2015.

But Novo has ideas that could put Victoza in the fast lane again. For one thing, the company recently filed for European approval for IDegLira, which combines Victoza's active ingredient with insulin degludec, a.k.a. Tresiba. Recently released data showed that the combination therapy beat Victoza and Tresiba at pushing blood sugar levels lower.

In clinical trials before its debut, Victoza patients lost more weight than patients taking comparator drugs. It was a "value-added benefit" noted by some researchers. So, Novo has since been testing Victoza as a weight-loss remedy, and the company plans to ask regulators to approve a new weight-loss indication by the end of 2013. Market researchers figure Victoza could quickly dominate the obesity market, given the slow starts for the two new weight-loss drugs approved last year, Vivus' ($VVUS) Qsymia and Arena Pharmaceuticals' ($ARNA) Belviq. Company executives are more circumspect. "I'd like to get the approval first," CEO Lars Rebien Sørensen told FiercePharma in August.

For more:
Novo Nordisk loses big U.S. contracts; Victoza, NovoLog sales to suffer
Novo's quick-selling Victoza threatened by Eli Lilly diabetes hopeful
Victoza weight-loss nod could rescue Novo from Tresiba delay, CEO says
Sharpening Victoza's edge, Novo touts data in trial against Januvia, Byetta
High-flying Victoza sales push Novo's forecasts up
Victoza gets superior-to-Januvia data added label

-- Tracy Staton (email | Twitter)

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Victoza - Novo Nordisk