) recently announced that it has received approval in Japan for
its diabetes treatment, Ryzodeg (insulin degludec/insulin
Ryzodeg was submitted for regulatory approval to the Japanese
Ministry of Health, Labour and Welfare in March 2012.
Ryzodeg is a soluble formulation of Tresiba (insulin degludec)
and NovoRapid (insulin aspart - known as NovoLog in the
Studies supporting the new drug application revealed that
Ryzodeg demonstrated a significantly lower risk of nocturnal
hypoglycaemia while successfully achieving equivalent reductions
in HbA1c vis-à-vis NovoMix.
We note that Tresiba, which is currently under regulatory
review in the EU and the US, was approved in Japan in September
2012. Both Tresiba and Ryzodeg received positive opinions from
the Committee for Medicinal Products for Human Use (CHMP) in the
EU in October 2012. Subsequently, the candidates received a
positive vote for approval from an FDA Advisory
Additionally, Novo Nordisk has submitted applications for
regulatory approval in Canada, Switzerland and a range of other
On a preliminary basis, Novo Nordisk expects a positive
contribution from Tresiba to the top line in 2013, primarily in
the US, EU and Japan, partially offset by a challenging operating
environment in major markets. However, operating costs will grow
considerably in the fourth quarter of 2012 due to significant
costs related to the expected launch of Tresiba, expanded sales
force in the US along with sales and marketing investments in
China and other international operations.
We are pleased with the company's efforts to strengthen its
presence in the diabetes market. The approval of Tresiba in Japan
and the potential approval of both Tresiba and Ryzodeg in the EU
and the US will together drive the company forward in bringing a
new generation of insulin in the market.
Meanwhile, Novo Nordisk recently completed a phase IIIa study
on IDegLira, which is a combination of Tresiba and Victoza
(liraglutide). Novo Nordisk is evaluating IDegLira for the
treatment of patients suffering from type II diabetes.
Although well placed in the diabetes market, Novo Nordisk
faces competition from other big players like
), Eli Lilly and Company (
) and Merck & Co.(
We currently maintain a Neutral recommendation on Novo
Nordisk. In the short run, the stock carries a Zacks #2 Rank
(Buy). Other pharma stocks with a Zacks #2 Rank are Sanofi (SNY)
and AstraZeneca (AZN).
LILLY ELI & CO (LLY): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
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