Teva Pharmaceutical Industries Ltd.
) recently received a boost with the company gaining US Food and
Drug Administration (FDA) approval for tbo-filgrastim (XM02
filgrastim). The FDA granted approval to tbo-filgrastim for the
reduction of the duration of severe neutropenia in certain types of
cancer (non-myeloid malignancies) patients who are receiving
chemotherapy that affects the bone marrow.
We note that filgrastim is already marketed in Europe by Teva
under the trade name Tevagrastim. Tevagrastim is a biosimilar of
The approval of tbo-filgrastim is a milestone for Teva's
oncology portfolio. As per the terms of a settlement agreement with
Amgen, Teva intends to launch tbo-filgrastim in early November
2013. Tbo-filgrastim is the first new granulocyte
colony-stimulating factor (G-CSF) to gain US approval in more than
Results from studies showed that tbo-filgrastim led to a
statistically significant reduction in the duration of severe
neutropenia compared to placebo. Data on the first 21-day
chemotherapy cycle showed that patients in the tbo-filgrastim arm
had severe neutropenia for an average of 1.1 days compared with 3.8
days for patients in the placebo arm.
We currently have a Neutral recommendation on Teva, which
carries a Zacks #3 Rank (short-term 'Hold' rating). We expect EU
sales to remain weak throughout the year.
Longer-term, the Cephalon acquisition should help Teva expand
and strengthen its branded and specialty pharma business. Moreover,
the favorable Copaxone ruling is a major win for the company and
should do away with any concerns regarding near-term generic
competition for the product. Teva can now focus on extending
Copaxone's life cycle.
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