Roche (RHHBY - Free Report) ’s Biologics License Application (BLA) for oncology candidate obinutuzumab (GA101) was recently accepted by the US Food and Drug Administration (FDA) for priority review.
The company is looking to get obinutuzumab approved for the treatment of patients suffering from chronic lymphocytic leukemia (CLL).
The application was primarily based on final stage 1 data from a phase III trial, CLL11 wherein it was observed that obinutuzumab plus chlorambucil achieved a statistically significant reduction of 86% in the risk of disease worsening or death.
The study was being conducted to evaluate the efficacy and safety of obinutuzumab plus chlorambucil (standard chemotherapy) or Roche’s MabThera/Rituxan plus chlorambucil vis-à-vis only chlorambucil in patients suffering from CLL.
A final decision is expected by Dec 20, 2013. We note that the FDA granted ‘Breakthrough Therapy Designation’ to obinutuzumab in May 2013 following the release of positive data from the CLL11 trial.
This designation should speed up the development and review of the candidate. Roche is also looking to get the candidate approved in the EU where a marketing application was submitted to the European Medicines Agency (EMA) in Apr 2013.
The successful development of obinutuzumab would help Roche replace revenues that may be lost to biosimilar versions of Rituxan once they enter the market.
We note that companies like Amgen (AMGN - Free Report) are working on biosimilar versions of Rituxan.
Rituxan is approved for the treatment of CLL. Rituxan was one of the best selling drugs for Roche in 2012 with sales of CHF 6.7 billion, up 9% year over year.
We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie (ABBV - Free Report) .
We are encouraged by the recent pipeline progress at Roche.
Roche currently carries a Zacks Rank #4 (Sell). Right now, Novo Nordisk (NVO - Free Report) looks attractive with a Zacks Rank #2 (Buy).