Biotech Values

[DewDiligence]

PFE, TEVA settle US Celebrex patent case:

http://finance.yahoo.com/news/teva-settles-patent-litigation-pfizer-123700095.html

Under the terms of the settlement, Teva may launch its generic versions in December, 2014, or earlier under certain circumstances.* Teva has received tentative approval from the U.S. Food and Drug Administration (FDA) for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. [Annualized] sales of Celebrex were $2.2 billion in the U.S. according to IMS...

This is a pretty good settlement for PFE insofar as PFE recently lost in US District Court on the RE44048 patent, which would have protected Celebrex US exclusivity until 12/2/15 (#msg-98718003). As a result, Celebrex is currently exposed to generic competition after 5/30/14, when two other patents expire (http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020998&Product_No=001&table1=OB_Rx ).

Thus, PFE’s settlement with Teva keeps Teva’s generic Celebrex off the US market an additional six months and is based on the leverage that PFE might have overturned the District Court’s ruling on appeal.

Meanwhile, ACT says it will launch generic Celebrex “at risk” in May 2014 if it receives FDA approval (#msg-98733372); however, ACT could yet decide to settle with PFE.

*This standard clause in generic-drug settlements means that, if another company (e.g. ACT) launches a generic version of Celebrex before Dec 2014, Teva can then launch also.