) is a leader in oncology drugs with strong demand for breast
cancer drugs like Herceptin, Perjeta and Kadcyla.
Apart from making efforts to develop its breast cancer
franchise, Roche is also keen to develop drugs for other
indications. One of the leading drugs in Roche's portfolio is
MabThera (branded as Rituxan in the U.S.) which is indicated for
blood cancers like non-Hodgkin's lymphoma (NHL) and chronic
lymphocytic leukemia (CLL).
Roche received positive news when the U.S. Food and Drug
Administration (FDA) approved another drug, Gazyva
(obinutuzumab), for the treatment of CLL.
The approval was based on positive results from the CLL11
trial wherein it was observed that Gazyva in combination with
chlorambucil chemotherapy led to a significant reduction in the
risk of disease progression or death. Moreover, it also improved
the life span of patients without their disease getting worse as
compared to chlorambucil alone.
Roche will present final data from the CLL11 trial in Dec
2013. The trial is evaluating Gazyva in combination with
chlorambucil and MabThera/Rituxan in combination with
We note that the FDA granted 'Breakthrough Therapy
Designation' to Gazyva in May 2013 following the release of
positive data from the CLL11 trial.
The successful commercialization of Gazyva would help Roche
replace revenues that may be lost to biosimilar versions of
Rituxan once they enter the market.
We note that companies like
) 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 the first nine months of
2013 with sales of CHF 5.2 billion, up 6% 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
Roche currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #2 (Buy).
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