Teva Pharmaceutical Industries Ltd. (TEVA) 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 Amgen’s (AMGN) Neupogen.
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 10 years.
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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