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CHMP Positive on Teva's Lonquex

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Teva Pharmaceutical Industries Ltd. (TEVA) 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 myelodysplastic syndromes).

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 Amgen’s (AMGN) Neupogen.

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 new strategy.

Amgen is also a Zacks Rank #3 stock. However, companies that currently look well-positioned include Biogen Idec (BIIB) and Anika Therapeutics Inc. (ANIK) - both are Zacks Rank #1 (Strong Buy) stocks.

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