Replies to post #127355 on Biotech Values

[DewDiligence]

NVS expects Gleevec generics to launch in the US market when the 5521184 composition-of-matter patent expires in Jul 2015. Sun Pharma has FDA approval for generic Gleevec.

[bellweather1]

Ponatinib/other TKIs-

DD,Thanks for that Gleveec/Tasigna stickiness chart.

Peter,

I guess the issue will be determined by how strong the long-term efficacy superiority of Pona is(and in which cohorts) when initiated 1st before other TKIs, and how statistically significant the effect is.

Thanks for the Gleevec color.

Any indications that other TKIs show similar advantages when started before Gleevec?; statistical significance?

Anyone aware of indications that Pona superior efficacy when employed earlier(before other TKIs) is likely to show statistically significant long-term efficacy(haven't attempted any calculations yet)?

Thanks,

bw

[DewDiligence]

The other 2nd-line agents are pretty clearly somewhat superior efficacy-wise to Gleevec based on head-to-head trials. All that Gleevec has going for it is much more long-term data and greater familiarity by doctors. Nevertheless, once Gleevec goes generic, I expect most insurers to require Gleevec be tried first in some sort of step-therapy approach.

There’s an outside chance that Sprycel could be available as a generic in the US market around the same time as a Gleevec generic. An undisclosed party submitted a Sprycel ANDA and Paragraph-IV challenge in Jun 2011:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm