Launch at Novo Nordisk

Zacks

Novo Nordisk (NVO) recently announced the availability of NovoSeven with a pre-filled syringe for the treatment of bleeding episodes in hemophilia patients. This will make treatment easier given the system’s ease of use, flexibility and a quick reconstitution process.

In Oct 2012, the treatment was approved by both the European Medicines Agency (:EMA) and the US Food and Drug Administration (:FDA). The product will be called “NovoSeven with pre-filled syringe” and “NovoSeven RT with MixPro” in the EU and the US, respectively.

Meanwhile Novo Nordisk is looking towards its two newly approved diabetes drugs, Tresiba and Ryzodeg, for driving long-term growth.

In Jan 2013, Novo Nordisk received approval in the EU (covering all 27 states) for both Tresiba and Ryzodeg. In the EU, Novo Nordisk is planning to launch Tresiba first and Ryzodeg a year later. Tresiba and Ryzodeg will be available in Novo Nordisk’s latest prefilled insulin pen named FlexTouch in Europe.

The Japanese Ministry of Health, Labour and Welfare (:MHLW) approved Tresiba and Ryzodeg for the treatment of diabetes in September and December 2012, respectively. A few days back, Novo Nordisk received approval of the price of Tresiba from MHLW.

However, in Feb 2013, Novo Nordisk faced a setback when the FDA declined to approve both diabetes candidates on the basis of the submitted data. The FDA issued a complete response letter (CRL) asking Novo Nordisk to conduct a dedicated cardiovascular outcomes study and provide additional cardiovascular data. Moreover, the FDA said that it will not grant approval to these candidates until the company resolves the issues mentioned in a warning letter given by the FDA in Dec 2012. The warning letter specified violations of current good manufacturing practice (:CGMP) regulations for finished pharmaceuticals at the company’s Novo Alle, Bagsvaerd Denmark facility.

Our Take

Though the launch of Novoseven with a prefilled syringe is encouraging, we are concerned about the presence of big players like Pfizer Inc. (PFE) for the control and prevention of bleeding episodes in hemophilia patients.

Novo Nordisk currently carries a Zacks Rank #2 (Buy). Other large-cap pharma companies like Bayer (BAYRY) and Eli Lilly and Company (LLY) also carry a Zacks Rank #2.

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