Magazine
#3 Novo Nordisk
Novo Allé, 2880 Bagsværd, Denmark
Tel: (45) 4444-8888 Fax: (45) 4449-0555
www.novonordisk.com
| Headcount | 27,000 | |
| Year Established | 1989 | |
| Biopharma Revenues | $8,989 | +17%/+9%* |
| Total Revenues | $8,989 | +17%/+9%* |
| Net Income | $1,903 | +21%/+13%* |
| R&D Budget | $1,550 | -1%/-8%* |
* Converted at avg. exch. rate / based on local currency (DKK)
| 2008 Top Selling Drugs | |||
| Drug | Indication | Sales | (+/-%) |
| Modern Insulins / Insulin Analogs | diabetes | $3,417 | +33% |
| Insulin and related | diabetes | $2,329 | +1% |
| Novoseven | hemostasis management | $1,262 | +17% |
| Growth hormone therapy | HGH deficiency | $763 | +18% |
Account for 86% of total pharma sales, same as in 2007.
PROFILE
Not being a type 2 diabetic (give me time), I don’t know much about the varieties of insulin and their suppliers. So I thought it was mighty impressive that Novo Nordisk finished 2008 with a 41% share of the total insulin market in North America, and a 32% share of the modern insulin market, by volume. Then I looked at some of its other regions. In Europe, NN has a marketshare of 55% of total insulin and 51% of modern. In Japan, those numbers are 72% for total insulin and 64% for modern insulin. So the company has room to grow in the U.S., is what I’m saying.
And, boy, has it grown. The company’s insulin sales in North America boomed 21% in 2008 in local currencies, and kept up that pace in 1Q09. With the wackiness of the 1Q09 exchange rates, NN’s North American growth was up 39% in Danish kroner. As America’s not the only market where NN has room to grow. The company is also trying to boost its presence in China (I know, I know: “Who isn’t?”). In November 2008, the company announced plans to invest $400 million in an insulin production facility in Tianjin, China. The plant will be NN’s primary production base in Asia-Pac and supply China and export markets. The company built a plant in Tianjin in 1996 and expanded it twice in the next decade. The new site will be its neighbor, measure 50,850 sq. m., be operational in 2012, and employ nearly 500 people.
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Bio in Seattle
In last year’s report, we detailed how Novo Nordisk elected to get out of small molecules and focus on biologics. While much of NN’s business is in diabetes treatment, the company is also pursuing inflammation and autoimmune conditions as part of its biopharma push. Back in 2000, NN spun off its Seattle, WA operations, but the company seems to have retained ties there (as well as a 30% stake in the spin-off, ZymoGenetics). In August 2008, NN quietly announced that it will build a specialized R&D center in Seattle, and plans to have as many as 80 scientists working at the center by 2010. The site will be headed by Don Foster, former vice president of research at ZymoGenetics. In an August 2008 interview with Joe Tartakoff of the Seattle Post-Intelligencer, Mr. Foster remarked that the financial investment in the Seattle site will be “very substantial,” but wouldn’t divulge numbers. Mr. Foster added, “Novo Nordisk is in this for the long run. A piece of what we will be doing in Seattle will be target discovery programs. As much as possible we are going to try to tailor those and differentiate them from the kind of approaches (that other) people are doing.” In December 2008, NN entered a collaboration with Seattle-based VLST, to identify targets and develop product candidates in the inflammation/autoimmune field. VLST was founded by a pair of Immunex vets, and uses “virulence factors” to streamline discovery of high quality, validated targets. The startup is working on a few compounds, although only one is approaching Phase I. |
Novo Nordisk’s collective fingers are crossed that the FDA will give the greenlight to liraglutide, the company’s new treatment for Type 2 diabetes. A glucagon-like peptide-1 (GLP-1) analog like Lilly/Amylin’s Byetta, liraglutide was filed with the FDA in May 2008. Worldwide sales of Byetta were around $750 million in 2008 and growing, according to Lilly. Liraglutide has an advantage over Byetta in that it’s a once-daily injection, while Byetta is twice-daily, but will liraglutide make it to the U.S. market before Lilly and Amylin can get approval for their Byetta LAR (Long Acting Release), a weekly injection? (Of course, NN is working on its own weekly GLP-1 analog, semaglutide, which recently finished Phase II trials.)
The company plans to launch liraglutide in the EU as Victoza this summer, having received a recommendation for approval in May 2009. In the U.S., an FDA advisory committee in April 2009 expressed concerns over cancerous thyroid tumors that developed in rats and mice during liraglutide’s testing. NN said that it’s working with the agency to resolve its concerns over the risk profile and has committed to conducting post-approval CV outcome study.
Oh, and a study published recently in the Lancet showed an advantage for liraglutide over Byetta, in terms of lowering “fasting plasma glucose” (look, I told you I’m not diabetic, okay?) in patients with Type 2. Both compounds led to a 6.5-lb. average weight loss during the six months of the study.
Not all of its trials have gone well. The company couldn’t prove efficacy of NovoSeven in treatment of acute bleeds in trauma, and it couldn’t get enough subjects together to run a trial on the benefits of growth hormone therapy for dialysis patients.
Liraglutide is NN’s highest profile new product, but the company has a couple more tricks up its sleeve. It’s planning Phase III trials for a pair of “new generation” insulins for the second half of 2009, has started a Phase III of recombinant factor VIII in patients with hemophilia A, and has started a one-year treatment period for a Phase III trial of recombinant FXIII in congenital factor XIII deficiency.
As long as people keep getting fat (and you can expect China’s diabetes cases to grow as it builds a middle class) and the Danish kroner doesn’t collapse, Novo Nordisk is in a great position. I make no guarantees about the currency, but I’m gonna bet on diabetes.
For the full Novo Nordisk profile, including pipeline and patent information, download the PDF.
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