Huge spike in Sarepta’s stock post news emerging on Drisapersen from Prosensa-GSK
Navi Mumbai, Maharashtra -- (SBWIRE) -- 09/24/2013 -- Dutch-based Prosensa Holding on Friday failed to report positive results from its study investigating drisapersen for the treatment of Duchenne Muscular Dystrophy or DMD. The study did not meet the primary endpoint of a statistically significant improvement in the 6-minute walking distance test versus placebo. At their Q2 results call in August, Prosensa’s CEO Hans Schikan noted that they had more than 300 patients participating in clinical studies of drisapersen at more than 50 trial sites in 25 countries.
Following the announcement of the negative study results, Hans Schikan re-affirmed their commitment to the study stating that they remain committed to the overall programme and would work closely with GSK. With the backing and support of a strong partner like GSK, Prosensa looks to be in the program for the long term. Hans Schikan has also stated that the program would be of critical importance to patients affected with DMD as currently there are no long-term disease modifying therapies available for the illness.
Meanwhile, attention has shifted towards Cambridge-based Sarepta Therapeutics Inc., which has been conducting Phase IIb clinical studies for eteplirsen, its lead product in the DMD space. The latest update on eteplirsen from their presentation at the Baird 2013 Healthcare Conference in September is that they’ve recently received feedback from the FDA that they're open to consider an NDA filing based on their Phase II data prior to a confirmatory study. Sarepta intends to start this study in the first quarter of next year with an NDA submission planned in the first half of next year. CEO Chris Garabedian sounded positive on the Phase II results at the Baird meeting stating that there were mainly 3 areas where they need to see success in: safety, the mechanism of action and clinical benefit. He believes Sarepta has unprecedented favorable data in all 3 of these areas.
Interestingly, on GSK’s Phase II data on dystrophin, at the conference, he stated that the data they've reported to-date “is really the lowest bar or threshold you could set for what is being described as an increase in dystrophin”.
Chris Garabedian also felt optimistic on stability data, i.e., how much they need to see in the NDA; comparability data and the amount of process validation, documentation that they want to see outlined in the NDA. Further updates on eteplirsen would be available once Sarepta meets with the FDA to talk about CMC (chemistry, manufacturing and controls) issues and what they will need to see in an NDA submission this October.
Along with presenting at the R.W. Baird 2013 Healthcare Conference, Sarepta’s CEO also took part in a Q&A meeting with Morgan Stanley’s Sara Slifka in September.
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