Teva Pharmaceutical Industries Ltd.
) recently received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) for its marketing
authorization application for Lonquex (XM22 lipegfilgrastim).
The company is looking to get Lonquex approved for reduction
in the duration of neutropenia and the occurrence of febrile
neutropenia in adults receiving cytotoxic chemotherapy for
malignancy (apart from chronic myeloid leukemia and
With the CHMP adopting a positive opinion, Teva will most
likely gain EU approval within a few months.
Teva has been working on strengthening its oncology portfolio.
The lead product in the company's oncology product portfolio is
Treanda. Treanda, which became a part of Teva's portfolio
following its acquisition of Cephalon, posted sales of $608
million in 2012.
Recent approvals in Teva's oncology segment include Synribo
and tbo-filgrastim in the US. While Synribo is approved for the
treatment of adults with chronic myelogenous leukemia (CML),
tbo-filgrastim is approved 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
As per the terms of a settlement agreement with Amgen, Teva
intends to launch tbo-filgrastim in early Nov 2013.
Teva currently carries a Zacks Rank #3 (Hold). The company is
going through a tough transition period given fewer large generic
opportunities, potential new competition for branded products
(especially Copaxone) and a higher cost base.
However, we are encouraged by Teva's plans to improve its
position. Teva said that it intends to accelerate growth
platforms, protect and expand core franchises, expand its global
presence, pursue strategic deals and reduce the cost base. We
expect investor focus to remain on the execution of the company's
Amgen is also a Zacks Rank #3 stock. However, companies that
currently look well-positioned include
) - both are Zacks Rank #1 (Strong Buy) stocks.
AMGEN INC (AMGN): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
TEVA PHARM ADR (TEVA): Free Stock Analysis
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