07.21.14
Headquarters: Bagsvaerd Denmark
twitter.com/novonordisk
www.novonordisk.com
TOP SELLING DRUGS
NovoNordisk continues to focus on diabetes therapeutics and new delivery systems, including oral solid dosage forms, which are being tested in early stage research. The company is also branching out with additions to its hemophilia, anti-inflammatory and growth products. It is also extending its presence in the anti-obesity market.
2012 had been a challenging year. FDA had asked for more data to review its insulin deludec therapy, Tresiba, causing a delay in the U.S. In addition, some concerns were raised on the safety of Victoza and the need for labeling. The company had to recall its NovoMix in some European countries, but the company followed up on each to minimize effects and improve practices.
NovoNordisk’s leaders say they responded quickly and effectively. In October, the company set a cardiovascular outcomes trial for Tresiba, designed to provide the data that FDA requested. It also filed IDegLira, a combination of liraglutide and insulin
degludec for treatment of Type 2 diabetes, in the EU. In addition, NovoNordisk filed liraglutide, Victoza’s active ingredient, as a potential obesity treatment in the U.S. and EU. Downstream, its FlexTouch and NovoPen Echo were approved by FDA for use with certain insulin products.
2013 sales and profit goals were met
Overall, company management reports, it met its sales and profit goals with sales up 12% and operating profits up 15%.
This year, the company is focusing on its continued roll out of Tresiba, but also on combination products such as Ryzodeb, which combines Tresiba with the fast-acting insulin NovoRapid and NovoEight.
Its IDegLira and 3-mg dose of liraglutide are still being reviewed for approval. The company also started Phase IIIa research on the faster-acting formulation of insulin aspart and moved semaglutide, a once-weekly treatment, into Phase III trials. For hemophilia, turoctocog alfa, a new Factor VIII product for people with hemophilia A was approved in U.S., EU and Japan.
For 2014, NovoNordisk management expects sales growth to reach 8-11%, as measured in local currencies.
Countering these expectations will be generic competition for Prandin, increased overall market competition, and changes in exchange rates. For 2014, operating profit growth is expected to be around 10% measured in local currencies, according to the company’s Annual Report. This reflects a significant increase in costs related to the continued progress of key development projects within diabetes and biopharmaceuticals.
In addition, significant costs are expected in relation to sales force expansions and sales and marketing investments in the portfolio of modern insulins and Victoza. In the U.S., China and selected markets in International Operations, the report says, as well as the launch of Tresiba outside the U.S. Given the current level of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 5.5 percentage points lower than growth measured in local currencies, according to the company’s 2013 annual report.
For 2014, Novo Nordisk expects a net financial income of around $137 million. Capital expenditure is expected to be around $729 million in 2014, the company reports, primarily related to investments in additional GLP-1 manufacturing capacity, expansion of filling capacity, prefilled device production facilities, construction of new laboratory facilities as well as expansion of protein capacity within the chemistry, manufacturing and control (CMC) department.
Responding to FDA’s request for more data on Tresiba, Novo Nordisk launched a cardiovascular outcomes test in October called DEVOTE. The company expects to have enough data to support an interim analysis within two to three years, and to complete the study within four to six years from initiation. The data will also be used to support the resubmission of Ryzodeg, the combination of Tresiba and insulin aspart, the company reports.
Last year, Novo Nordisk filed IDegLira for regulatory review in the EU. IDegLira is a fixed combination of insulin degludec and liraglutide. Filing IDegLira in the U.S. will depend on the outcome of the interim analysis planned for the DEVOTE trial.
Faster-acting Insulin
Novo Nordisk has also begun the Phase IIIa clinical program, Onset, for faster-acting or formulation of insulin aspart. The
improved formulation is intended to enable a faster onset of appearance of insulin in the bloodstream.
In the U.S., the FDA approved Novo Nordisk’s FlexTouch delivery system for NovoLog. FlexTouch is a prefilled pen featuring a spring-loaded dosing action that allows users to administer insulin at the touch of a button—regardless of dosage size. The pen has been launched in the EU and Japan. FDA also approved the reusable NovoPen Echo for administering NovoLog.
Novo Nordisk initiated Phase IIIa trials investigating the efficacy and safety of liraglutide as an adjunct therapy to insulin in people with Type 1 diabetes. The company also brought a tablet formulation of semaglutide, OG217SC, into Phase II testing.
Pioneering the effort within oral diabetes proteins, Novo Nordisk now has seven oral formulations of insulin and GLP-1 analogues in the early pipeline, in Phases I and II. In obesity treatments, the company completed its SCALE Phase IIIa program, results of which confirmed the efficacy and safety of liraglutide (3 mg formulation) for this application, which was filed for review in the U.S. and EU in December.
twitter.com/novonordisk
www.novonordisk.com
Headcount: | 38,436 | |
Year Established: | 1989 | |
Total Revenues: | $15,422 | 12% |
Net Income: | $4,653 | 15% |
R&D Budget: | $2,168 | 1% |
TOP SELLING DRUGS
Drug | Indication | 2013 Sales | (+/- %) |
NovoRapid/NovoLog | diabetes | $3,109 | 7% |
NovoMix/NovoLog Mix | diabetes | $1,801 | 4% |
Levemir | diabetes | $2,130 | 18% |
Victoza | diabetes | $2,146 | 23% |
NovoSeven | hemophilia | $1,708 | 4% |
Norditropin | human growth hormone | $1,128 | 7% |
NovoNordisk continues to focus on diabetes therapeutics and new delivery systems, including oral solid dosage forms, which are being tested in early stage research. The company is also branching out with additions to its hemophilia, anti-inflammatory and growth products. It is also extending its presence in the anti-obesity market.
2012 had been a challenging year. FDA had asked for more data to review its insulin deludec therapy, Tresiba, causing a delay in the U.S. In addition, some concerns were raised on the safety of Victoza and the need for labeling. The company had to recall its NovoMix in some European countries, but the company followed up on each to minimize effects and improve practices.
NovoNordisk’s leaders say they responded quickly and effectively. In October, the company set a cardiovascular outcomes trial for Tresiba, designed to provide the data that FDA requested. It also filed IDegLira, a combination of liraglutide and insulin
degludec for treatment of Type 2 diabetes, in the EU. In addition, NovoNordisk filed liraglutide, Victoza’s active ingredient, as a potential obesity treatment in the U.S. and EU. Downstream, its FlexTouch and NovoPen Echo were approved by FDA for use with certain insulin products.
2013 sales and profit goals were met
Overall, company management reports, it met its sales and profit goals with sales up 12% and operating profits up 15%.
This year, the company is focusing on its continued roll out of Tresiba, but also on combination products such as Ryzodeb, which combines Tresiba with the fast-acting insulin NovoRapid and NovoEight.
Its IDegLira and 3-mg dose of liraglutide are still being reviewed for approval. The company also started Phase IIIa research on the faster-acting formulation of insulin aspart and moved semaglutide, a once-weekly treatment, into Phase III trials. For hemophilia, turoctocog alfa, a new Factor VIII product for people with hemophilia A was approved in U.S., EU and Japan.
For 2014, NovoNordisk management expects sales growth to reach 8-11%, as measured in local currencies.
Countering these expectations will be generic competition for Prandin, increased overall market competition, and changes in exchange rates. For 2014, operating profit growth is expected to be around 10% measured in local currencies, according to the company’s Annual Report. This reflects a significant increase in costs related to the continued progress of key development projects within diabetes and biopharmaceuticals.
In addition, significant costs are expected in relation to sales force expansions and sales and marketing investments in the portfolio of modern insulins and Victoza. In the U.S., China and selected markets in International Operations, the report says, as well as the launch of Tresiba outside the U.S. Given the current level of exchange rates versus the Danish krone, the reported operating profit growth is now expected to be around 5.5 percentage points lower than growth measured in local currencies, according to the company’s 2013 annual report.
For 2014, Novo Nordisk expects a net financial income of around $137 million. Capital expenditure is expected to be around $729 million in 2014, the company reports, primarily related to investments in additional GLP-1 manufacturing capacity, expansion of filling capacity, prefilled device production facilities, construction of new laboratory facilities as well as expansion of protein capacity within the chemistry, manufacturing and control (CMC) department.
Responding to FDA’s request for more data on Tresiba, Novo Nordisk launched a cardiovascular outcomes test in October called DEVOTE. The company expects to have enough data to support an interim analysis within two to three years, and to complete the study within four to six years from initiation. The data will also be used to support the resubmission of Ryzodeg, the combination of Tresiba and insulin aspart, the company reports.
Last year, Novo Nordisk filed IDegLira for regulatory review in the EU. IDegLira is a fixed combination of insulin degludec and liraglutide. Filing IDegLira in the U.S. will depend on the outcome of the interim analysis planned for the DEVOTE trial.
Faster-acting Insulin
Novo Nordisk has also begun the Phase IIIa clinical program, Onset, for faster-acting or formulation of insulin aspart. The
improved formulation is intended to enable a faster onset of appearance of insulin in the bloodstream.
In the U.S., the FDA approved Novo Nordisk’s FlexTouch delivery system for NovoLog. FlexTouch is a prefilled pen featuring a spring-loaded dosing action that allows users to administer insulin at the touch of a button—regardless of dosage size. The pen has been launched in the EU and Japan. FDA also approved the reusable NovoPen Echo for administering NovoLog.
Novo Nordisk initiated Phase IIIa trials investigating the efficacy and safety of liraglutide as an adjunct therapy to insulin in people with Type 1 diabetes. The company also brought a tablet formulation of semaglutide, OG217SC, into Phase II testing.
Pioneering the effort within oral diabetes proteins, Novo Nordisk now has seven oral formulations of insulin and GLP-1 analogues in the early pipeline, in Phases I and II. In obesity treatments, the company completed its SCALE Phase IIIa program, results of which confirmed the efficacy and safety of liraglutide (3 mg formulation) for this application, which was filed for review in the U.S. and EU in December.