) recently announced that the US Food and Drug Administration
(FDA) has approved an additional indication for Promacta
(eltrombopag), also known as Revolade in the EU and other
countries. The FDA approved the product for the treatment of
thrombocytopenia in patients with chronic hepatitis C virus (HCV)
infection to enable the initiation of interferon-based therapy
and to achieve optimum results with interferon-based therapy.
We note that interferon-based therapies are commonly prescribed
treatments for chronic HCV infection.
The Promacta label expansion however came with certain
restrictions - it should not be used to normalize platelet counts
and should only be used when interferon therapy cannot be
initiated or maintained by HCV patients due to thrombocytopenia.
Additionally, the efficacy and safety profile of Promacta in
combination with antiviral agents for HCV infection has not been
In November 2011, Glaxo had presented positive results from phase
III trials evaluating the use of Promacta for thrombocytopenia in
patients with chronic HCV infection. Full results from the ENABLE
1 trial and initial data from ENABLE 2 were reported. Both trials
met the primary endpoint. It was found that patients who received
Promacta along with
) Pegasys (peginterferon alfa-2a) and ribavirin antiviral therapy
achieved a statistically significant improvement over patients
Promacta is approved for the treatment of idiopathic
thrombocytopenic purpura (ITP), a condition which causes
increased risk of bruising and bleeding. Glaxo has a research
collaboration agreement with
Ligand Pharmaceuticals Inc.
) for this drug. Promacta sales increased 59% from the year-ago
quarter to £35 million in the third quarter of 2012.
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We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
Several products in Glaxo's portfolio including Valtrex, Arixtra,
Evoclin, Lamictal, Imitrex, Requip, Combivir and Epivir are
facing declining sales due to intense generic competition. We
expect the company's top line and gross margins to remain under
pressure in the coming quarters. EU pricing pressure will
continue to affect sales as well.
Glaxo is aiming to maximize the potential return from its
pipeline. The company is looking toward deals and acquisitions to
drive growth. Further, the company is focusing on increasing the
rights on its partnered products and promising pipeline
candidates, so that it stands to benefit more from their success.
Glaxo's acquisition of Cellzome and Human Genome Sciences,
increasing investment in
) and amended agreement between ViiV Healthcare and Shionogi
indicate its efforts to expand the pipeline.
Apart from this, Glaxo continues to progress on its cost-cutting
initiative, which should help reduce the impact of increasing
generic competition over the next few years and boost