) announced that the European Commission has approved Tyverb in
) 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.
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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
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
Meanwhile, stocks such as
Gilead Sciences, Inc.
) currently look more attractive in the pharma space with a Zacks
Rank #1 (Strong Buy).