Replies to post #158811 on Biotech Values

[DewDiligence]

Aubagio does have FDA NCE status—see http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202992&Product_No=001&table1=OB_Rx .

This is a useful benchmark for the FDA’s thinking on NCE status insofar as Aubagio is nearly indistinguishable from Arava in vivo.

[DewDiligence]

CHMP reverses non-NAS* status for SNY’s Aubagio:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001827.jsp&mid=WC0b01ac058004d5c1

The CHMP adopted a positive re-examination opinion for Aubagio, revising its previous opinion not to grant new active substance status to the medicine at its March 2013 meeting.

Thus, Aubagio is now entitled to the standard “8+2+1” EU exclusivity afforded to new drugs.

As previously noted (#msg-86099393), Aubagio has five years of US exclusivity conferred by FDA NCE status despite the fact that it’s almost indistinguishable from a prior approved drug (Aravo) in vivo.

*New Active Substance (equivalent to NCE status in US terminology).