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Glaxo's Tyverb Gets EU Approval

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Recently, GlaxoSmithKline (GSK - Free Report) announced that the European Commission has approved Tyverb in combination with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab) for the treatment of patients with metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer who have received prior Herceptin therapy.

The approval did not come as a surprise as, in Jun 2013, the Committee for Medicinal Products for Human Use had rendered a positive recommendation on Tyverb.

The approval was based on encouraging data from the randomized, open-label, phase III EGF104900 study.

We note that Glaxo submitted the marketing application for Tyverb in the EU and the U.S. (U.S. trade name: Tykerb) in Feb 2012. However, in July, Glaxo withdrew the marketing application for Tykerb from the FDA. The decision to withdraw the application was taken after the FDA raised issues regarding the use of Tykerb, which Glaxo was unable to address on the basis of the available data.

Tykerb is currently approved in combination with Roche’s Xeloda for treating patients suffering from advanced or metastatic HER2 positive breast cancer who have received prior therapy including an anthracycline, a taxane, and Herceptin. It is also approved in combination with Femara (letrozole) for postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor.

Glaxo currently holds a Zacks Rank #3 (Hold). The biggest near-term challenge for Glaxo will be to replace the revenues that will be lost to generic competition. Products like Valtrex, Lamictal, Imitrex, Requip, Combivir and Epivir are already facing declining sales due to intense generic competition. Going forward, a major part of Glaxo’s revenues will be exposed to generic competition, as products like Pandemrix and Prepandrix are all scheduled to lose exclusivity in the next few quarters.

We believe that the pipeline at Glaxo must deliver to counter the generic threat. We are impressed by Glaxo’s growth-by-acquisition strategy to combat the loss of revenues due to genericization of key products.

Meanwhile, stocks such as Actelion and Gilead Sciences, Inc. (GILD - Free Report) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

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