Replies to post #175233 on Biotech Values

[RockRat]

Thanks for the dig. I've been waiting to see data on the clinical experience of patients taking these Copaxone knock offs that we all knew would be inadequate. Not sure why it took so long. In spite of Teva's continued position that clinical trials should be required of Copaxone generics, the presentation seems to provide some analytical techniques that would do the job of proving sufficient similarity. One of these is even lifted from a fairly old (2008) Momenta patent.

The slides do document how high that hurdle is, and may be the reason behind MNTA shares' underperformance in recent days.

Regards, RockRat

[jq1234]

Thanks for the link. This came from the most recent Teva Citizen Petition regarding generic Copaxone filed in Dec2013:

http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2013-P-1641

Compare to previous one filed in Jun2012 and denied in Dec2012:

http://www.regulations.gov/#!docketDetail;D=FDA-2012-P-0555

Per Dec2012 FDA denial letter:

https://www.dropbox.com/s/i5ihpsiilw1smsu/Photo%20Mar%2009%2C%203%2041%2054%20PM.png

It seems FDA is ready to rule in near term, maybe on or before required date when FDA have to respond to Teva current Citizen Petition.

The most interesting part of presentation to me is Teva analyzed generic Copaxone launched in India, Mexico, Argentina, but unable to obtain versions currently under FDA review. I would assume similar/equivalent methodology could have already been used in MNTA's version in support of ANDA filing and review.

[DewDiligence]

Teva’s Copaxone findings are more of an issue for MYL, whose source product came from India, than for NVS/MNTA, whose generic Copaxone is de novo.