Updates related to pipeline and label expansion efforts are
eagerly awaited by investors in the biotech/pharma space as these
play a crucial role in their investment decisions. These updates
provide an insight into the commercial potential of a
) announced encouraging results from the phase III PETIT2 study on
Promacta. The study evaluated the efficacy, safety and tolerability
of Promacta in pediatrics with previously treated chronic immune
(idiopathic) thrombocytopenic purpura (cITP) as compared to
Results from the study revealed that patients under Promacta
treatment showed a statistically significant improvement in
platelet count compared to those under placebo. This was also the
primary endpoint of the study. Results from the study were
presented at the European Haematology Association Annual Congress.
Glaxo also mentioned that the efficacy results in the phase III
study were consistent throughout other age cohorts. Moreover, the
safety profile of the drug was also similar to the established
profile of Promacta. Glaxo intends to file regulatory applications
for Promacta for the above indication later in the year.
Glaxo has a licensing agreement with
Ligand Pharmaceuticals Incorporated
) for Promacta. Ligand receives royalties on the sales of the drug.
We note that Promacta is currently approved for the treatment of
thrombocytopenia (low blood platelet count) in patients with cITP.
The drug is also approved for the treatment of thrombocytopenia in
patients with chronic hepatitis C virus (HCV) infection. Promacta
is marketed in Europe and other countries across the world under
the trade name Revolade.
The companies are looking to get Promacta approved in other
indications as well. In Feb 2014, Glaxo and Ligand submitted a
supplemental New Drug Application (sNDA) for Promacta in the U.S.
for the treatment of cytopenias (reduction in blood cells) in
patients suffering from severe aplastic anemia (SAA), who have not
responded sufficiently to immunosuppressive therapy. Promacta
enjoys breakthrough therapy designation in the U.S. for the SAA
Glaxo has progressed well with Promacta. Further label expansion of
the drug should drive growth. Promacta sales grew 19% year over
year in the first quarter of 2014.
Glaxo carries a Zacks Rank #3 (Hold). Right now, stocks like
) look better placed in the healthcare space. Both Allergan and
Gilead carry a Zacks Rank #1 (Strong Buy).
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