FDA Approval for Teva Product - Analyst Blog

By Zacks.com,  September 04, 2012, 09:37:17 AM EDT

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.
 


 
AMGEN INC (AMGN): Free Stock Analysis Report
 
TEVA PHARM ADR (TEVA): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research




The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.


This article appears in: Investing, Business, Stocks

Referenced Stocks: AMGN, TEVA



Latest News Video

On Facebook IPO's Anniversary, a Look Back at the Year
On Facebook IPO's Anniversary, a Lo...


Sign-in
Existing NASDAQ.com member? Log in here.

By signing into to the site using any of the third-party services above, you agree to NASDAQ.com's Terms of Use.

From Our Trusted News Source





Most Active by Volume:

Company Last Sale Change Net / %
BAC $ 13.43 0.07  0.52%
CSCO $ 24.24 0.35  1.48%
MSFT $ 34.87 0.79  2.32%
F $ 15.08 0.44  3.01%
ARUN $ 13.10 4.51  25.61%
SIRI $ 3.50 0.05  1.45%
GE $ 23.46 0.19  0.82%
S $ 7.32 0.04  0.55%