GlaxoSmithKline (GSK - Free Report) 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 (DMD).
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 BV.
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 Biogen Idec (BIIB - Free Report) , Santarus, Inc. and Novo Nordisk (NVO - Free Report) . While Biogen and Santarus are Zacks Ranked #1 (Strong Buy) stocks, Novo Nordisk is a Zacks Ranked #2 (Buy) stock.