Label Expansion for Roche's Pegasys

Zacks Equity Research
March 21, 2013

Roche Holding AG (RHHBY) recently announced that the European Medicines Agency (:EMA) has approved a label expansion for Pegasys in combination with ribavirin for the treatment of chronic hepatitis C virus (:HCV) in children and adolescent five years and older.

We note that Pegasys plus antiviral ribavirin is approved for the treatment of chronic HCV, human immunodeficiency virus (:HIV)/HCV co-infection and chronic hepatitis B in adults.

Children and adolescents aged five years or more who have not received prior treatment and have been tested positive can now be treated with Pegasys plus ribavirin. Roche had conducted a randomized controlled study based on which approval was granted.

The study results revealed that a larger percentage of children treated with the Pegasys plus ribavirin combination achieved sustained viral response than the children treated with Pegasys alone (53% versus 21%). The results in children and adolescents were similar to the results observed in adults infected with HCV genotype I.

We note that companies like Merck & Co. Inc. (MRK) and Vertex Pharmaceuticals Inc. (VRTX) have a presence in the HCV market.

The label expansion on Pegasys into the children and adolescent population is a positive. Recently, Roche received US Food and Drug Administration (:FDA) approval for a next-generation viral load test for use in chronic HCV patients. We are pleased with Roche’s progress in the treatment of HCV.

Roche currently carries a Zacks Rank #4 (Sell). Stocks which currently look well-positioned include Novo Nordisk (NVO). Novo Nordisk carries a Zacks Rank #2 (Buy).

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