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Diabetes Giants Battle Outside of Their Usual Arena

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Drugmaker Novo Nordisk (NYSE: NVO  ) had a big week with approvals of its Levemir FlexTouch pre-filled insulin pen in Canada and its recombinant coagulation factor VIII Novoeight for treatment of hemophilia A in the U.S.

Novo's Levemir FlexTouch, an injection pen pre-loaded with a long-acting basal insulin, was approved by Health Canada approved for use in type 1 and type 2 diabetes. It is expected to go to market in January 2014, already claiming better patient comfort and subsequently compliance to the spring-loaded mechanism of the pen that minimizes injection force.

Blood sugar becomes blood and sugar
Although Novo is known as a diabetes giant, accounting for five of the 10 top-selling diabetes medications worldwide in 2012, it also has expertise in hemophilia treatments, growth hormone, and hormone replacement therapy.

Hemophilia A is a disease caused by a lack of factor VIII, a compound necessary to clot blood. Without it, patients can bleed out from minor injuries. A similar disease that Novo is targeting is Hemophilia B, a bleeding disorder caused by a lack of factor IX.

Novo already produces NovoSeven for treatment of both hemophilia A and B, generating $1.5 billion in revenue last year. However, the company has expected a decline in sales and since made several attempts at new compounds for hemophilia. This past June, the FDA rejected Novo's attempt of a recombinant factor XIII for treatment of a rare bleeding disorder caused by deficiency of the factor, citing concerns with manufacturing. Last year, Novo trashed a factor VIIa product atreptacog alfa, a compound similar to NovoSeven, due to patients developing antibodies to the drug. This makes U.S. FDA approval of Novoeight all the sweeter.

NovoEight is a recombinant coagulation factor VIII called turcotocod alfa. It is expected to go to market in the U.S. in April 2015 and was approved last month in Europe by the Committee for Medicinal Produce for Human Use, or CHMP, with projected release to market in early 2014. Indications approved by the FDA include control and prevention of bleeding, perioperative management and prophylaxis -- indications that may allow Novo to garner lifelong patients from the 350,000 patients afflicted by hemophilia A. The company also has a compound, N9-GP, in phase 3 trials with initial results showing promise.

Novo certainly has prominence in the diabetes space and none of its hemophilia rivals like Baxter, Bayer AG, Pfizer or Biogen can claim any significant market share on the sweet stuff.

Beyond the sweet stuff
However, Novo's diabetes rivals are also expanding beyond insulin. Sanofi (NYSE: SNY  ) , maker of top-selling insulin Lantus ($6.67 billion in 2012), has partnered with Regeneron Pharmaceuticals in the development of alirocumab, a cholesterol-lowering agent. Initial studies show LDL cholesterol (the "bad" cholesterol) lowered by 47% over 6 months as compared to Merck's (NYSE: MRK  ) Zetia, which only a 15% reduction of LDL over the same time period.

Not to be outdone, Novo has continued to try to develop a competitor to Sanofi's Lantus, but its most promising candidate Tresiba will not launch until 2018,  requiring additional studies of its potential cardiovascular side effects. In the meantime, Sanofi continues to improve Lantus into a longer-acting formulation with fewer episodes of hypoglycemia to compete with claims Novo is making about Tresiba.

Cholesterol agents aside, Merck and Sanofi have long competed in the diabetes space. Merck's incretin mimetic Januvia accounts for $4.05 billion in  sales. Januvia works by helping stimulate release of insulin, working only in type II diabetics; Merck is also responsible for Janumet, a combination drug of Januvia and metformin. Unfortunately, both Januvia and Janumet are facing FDA evaluation of pancreatic cancer risk, giving competing drugs of similar mechanisms like Invokana by Johnson & Johnson an edge. 

With plenty of movement in the diabetes area, rivals Novo, Merck and Sanofi will continue to expand outside of that field, although they seem to be butting heads already in their new spheres. While Merck and Sanofi continue to compete with their cholesterol agents, Novo reigns supreme in its unique position in both bleeding disorders and diabetes. As its recent approvals open to consumers, Novo can expect more success in the market.

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