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April 24, 2008

COPAXONE from the START of MS

Analysis of: Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS | www.pipelinereview.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Daniel Wynn, MD, Director, Clinical Research, Consultants In Neurology Ltd.Daniel Wynn, MD 
Director, Clinical Research, Consultants In Neurology Ltd.
Implications: Copaxone has become the leading treatment for relapsing remitting MS in the US.  The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.

Analysis: Most US neurologist when asked state they like to start MS patients on therapy at the first definite sign of MS, clinically isolated syndrome. In truth, most patients  have several events before being started on therapy.  One big concern is side effects of interferons, and a second concern is the lack of data showing that Copaxone is effective at decreasing progression to clinically definite MS.  In the PreCISe trial, the  time to relapse was doubled for those on Copaxone versus placebo.  Similarly, using the  most conservative measures, Copaxone had a very robust effect on MRI.

Much additional imaging data will be forthcoming from this trial, which included many non-conventional imaging techniques, magnetic resonance spectroscopy and others.  This will also help TEVA in the marketplace.

Similarly,  TEVA has a trial of a double dose (40 mg) in head to head study versus Copaxone 20 mg (FORTE trial).  If as in the phase II trial 40 works better than 20, watch out.  This data will also add much given that Rebif and Betaseron in Serono and Bayer sponsored trials respectively showed no significant advantage over 20 mg Copaxone.

The PreCISe study adds strength to TEVAs portfolio -- their first drug to likely obtain approval for clinically isolated syndrome (as does Biogen Idec's Avonex).  With oral laquinimod also in trial by TEVA, this strengthens TEVA's future position in the MS marketplace.


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