Replies to post #204137 on Biotech Values

[Fred Kadiddlehopper]

Dew, in reading this I realized I don't know the answer to the following basic question: Does the approval for a new indication extend the IP rights (time-wise) for that drug? Is so are the patents extended for the drug in general or only for that new indication?
Thanks!
-Fritz

[Titan V]

With Opdivo in its sights, Merck's Keytruda nabs breakthrough tag in first-line lung cancer
http://www.fiercepharma.com/pharma/opdivo-its-sights-merck-s-keytruda-nabs-breakthrough-tag-1l-lung-cancer

[DewDiligence]

FDA approves Keytruda in first-line NSCLC:

http://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-220400949.html

Merck…today announced that the U.S. Food and Drug Administration has approved KEYTRUDA (pembrolizumab)…for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations [i.e. patients with relevant EGFR or ALK mutations get “targeted” therapy rather than immunotherapy in the first–line setting].

…In metastatic NSCLC, KEYTRUDA is approved for use at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

I expect that a fair proportion of patients who have not progressed in 24 months will continue to take Keytruda, if reimbursement is not an issue.

This FDA approval, which was not in doubt, comes two months before the 12/24/16 PDUFA date. The timing is perfect insofar as MRK reports 3Q16 results tomorrow.