) plummeted more than 70% to $7.14 on Sep 20, 2013, following the
announcement of negative data from a phase III study on
drisapersen. Prosensa is developing drisapersen in collaboration
) for the treatment of patients suffering from Duchenne muscular
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We note that Prosensa granted Glaxo an exclusive worldwide
license to develop and commercialize drisapersen in 2009.
The randomized, double-blind and placebo-controlled phase III
study compared the use of drisapersen versus placebo in DMD
patients. The study failed to meet the primary endpoint as
drisapersen did not show statistically significant improvement in
the 6 Minute Walking Distance (6MWD) test versus placebo. No
difference in the key secondary assessments of motor function was
Full evaluation of the benefit-to-risk profile of drisapersen is
expected to be completed by the end of 2013.
Drisapersen enjoys orphan drug status in the EU, Japan and the
U.S. In Jun 2013, the U.S. Food and Drug Administration (FDA)
granted breakthrough therapy designation to drisapersen. We note
that the breakthrough therapy 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
We note that several other companies including
Sarepta Therapeutics, Inc.
) are developing therapies targeting the DMD market. Sarepta
shares climbed 18% on the drisapersen setback news.
Prosensa carries a Zacks Rank #4 (Sell) while Glaxo carries a
Zacks Rank #3 (Buy). Currently, companies like
) look more attractive with a Zacks Rank #1 (Strong Buy).