) recently announced that the US Food and Drug Administration
(FDA) granted breakthrough therapy designation to its late-stage
candidate, drisapersen. Glaxo is developing drisapersen for the
treatment of patients suffering from Duchenne muscular dystrophy
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According to Glaxo, DMD is a rare condition which affects 1 in
3,500 live male births.
The designation, which was enacted as part of the 2012 Food and
Drug Administration Safety and Innovation Act, is granted to
potential new treatments for serious or life-threatening diseases
or conditions where the initial clinical data shows that the
treatment has the potential to demonstrate substantial
improvement on one or more clinically significant endpoints
compared to existing treatments. The designation should help
fasten the development and review process for the candidate.
We note that the designation was granted to drisapersen on the
basis of data from a phase II study which evaluated the use of
the candidate in patients suffering from DMD.
Apart from breakthrough therapy designation, drisapersen also
enjoys orphan drug status in the EU and the US.
We note that Glaxo is developing drisapersen in collaboration
with Denmark-based biopharmaceutical company, Prosensa Holding
We note that the generic competition that Glaxo is currently
facing or expects to face for its key drugs has put significant
pressure on the company. 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 drugs such as Pandemrix and Prepandrix are scheduled to lose
exclusivity in the next few quarters. We believe the
pipeline at Glaxo, which includes interesting candidates such as
drisapersen, must deliver to combat the declining revenues due to
the genericization of key drugs
Glaxo carries a Zacks Rank #3 (Hold). Companies that currently
look well-positioned include
). While Biogen and Santarus are Zacks Ranked #1 (Strong Buy)
stocks, Novo Nordisk is a Zacks Ranked #2 (Buy) stock.