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Pipeline Progress at Roche

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Roche (RHHBY - Free Report) recently released promising data on oncology candidate, RG7601 (GDC-0199/ABT-199), from a phase I study.

Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie (ABBV - Free Report) .

It was observed that RG7601 achieved an overall response rate of 84% in the CLL arm of the study (n=55) while a 53% overall response rate was observed among patients in the NHL arm of the study (n=32).

The US Food and Drug Administration (FDA) recently accepted Roche’s/AbbVie’s amended clinical trial protocols for studies on RG7601 in patients suffering from CLL.

Roche continues to work towards boosting its hematology franchise. We note that Roche already has Rituxan (MabThera) in its portfolio, approved for the treatment of CLL and NHL.

Rituxan was one of the best selling drugs for Roche in 2012 with sales of CHF 6.7 billion, up 9% year over year.

Additionally, Roche has obinutuzumab (GA101) in its pipeline, currently in phase III, for the treatment of CLL and NHL.

Roche announced positive data on obinutuzumab from a phase III study in May 2013. Roche has submitted marketing applications to regulatory authorities including the European Medicines Association (EMA) and the FDA.

The FDA has granted obinutuzumab ‘Breakthrough Therapy Designation.’

We believe that the successful development of obinutuzumab and RG7601 will help Roche replace revenues that may be lost to biosimilar versions of Rituxan once they enter the market.

Companies like Amgen (AMGN - Free Report) are working on biosimilar versions of Rituxan.

Roche currently carries a Zacks Rank #3 (Hold). Right now, Salix Pharmaceuticals looks attractive with a Zacks Rank #1 (Strong Buy).

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