CHMP Positive on Teva's Lonquex - Analyst Blog

By
A A A

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.



AMGEN INC (AMGN): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

BIOGEN IDEC INC (BIIB): 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 , ANIK , BIIB , CHMP , TEVA

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Can Magnets Relieve Pain?
Can Magnets Relieve Pain?           
The Danger of Small ETFs
The Danger of Small ETFs            

Stocks

Referenced

Most Active by Volume

27,000,881
  • $16.245 ▼ 0.52%
22,637,367
  • $74.8674 ▼ 1.44%
20,303,500
  • $101.91 ▲ 1.01%
19,883,841
  • $3.59 ▲ 0.84%
15,764,309
  • $47.83 ▼ 0.71%
14,245,046
  • $18.7845 ▲ 3.04%
13,582,245
  • $38.081 ▲ 0.77%
12,567,254
  • $10.295 ▼ 3.70%
As of 8/27/2014, 12:32 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com