) received encouraging news with the European Medicines Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP)
recommending the approval of two of its oncology drugs, Tafinlar
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The CHMP recommended the approval of Tafinlar for BRAF V600E
mutation-positive unresectable or metastatic melanoma patients.
We note that the US Food and Drug Administration (FDA) approved
Tafinlar for the above mentioned indication in May 2013. However,
Tafinlar was not recommended by the FDA for patients suffering
from wild-type BRAF melanoma. The FDA also cited several warnings
and precautions related to the use of Tafinlar, which can lead to
fatal side effects including increasing the risk of developing
new primary cutaneous malignancies.
Glaxo intends to launch the drug in the US by early third quarter
2013. Currently approved melanoma drugs include
) Zelboraf and
Bristol-Myers Squibb Co.
Meanwhile, the CHMP also recommended the approval of Tyverb in
combination with Roche's 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.
We note that Glaxo submitted the marketing application for Tyverb
in the EU and the US (US 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 with currently 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
Companies that currently look more attractive include
) carrying a Zacks Rank #2 (Buy).