GlaxoSmithKline
(
GSK
) recently announced that it has submitted marketing applications
for Promacta (eltrombopag), known as Revolade in the EU and other
countries. The company has submitted a supplemental New Drug
Application (sNDA) to the US Food and Drug Administration (FDA) for
Promacta. A variation to the Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMA) for Revolade has also
been submitted.
Glaxo is looking to get the drug approved for the treatment of
thrombocytopenia in adult 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.
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
Roche's
(
RHHBY
) Pegasys (peginterferon alfa-2a) and ribavirin antiviral therapy
achieved a statistically significant improvement over patients
receiving placebo.
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.
(
LGND
) for this drug. Promacta sales more than doubled from the year-ago
quarter to £27 million in the first quarter of 2012.
Neutral on Glaxo
We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #3 Rank (Hold rating) in the short run. A major
part of Glaxo's revenues will be exposed to generic competition as
multiple drugs are scheduled to lose exclusivity in the next few
years.
We expect the company's top line as well as gross margins to
remain under pressure in the coming quarters. In addition to
generic competition, EU pricing pressure will continue to affect
sales.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
Report
LIGAND PHARMA-B (LGND): Free Stock Analysis
Report
(RHHBY): ETF Research Reports
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