Wednesday, May 6, 2009

More -- on Schering-Plough's Larger Drug Franchise "In-Substance" Patent Cliffs


As I noted toward the end of this post, even though many on Wall Street tout Schering-Plough's relative dearth of formal patent expiries (most after 2014; many in the 2017 to 2019 time-frame) -- there is another side to this story. That story involves the right, under the various Hatch-Waxman amendments, of generic manufacturers to launch generic versions of most of these drugs, "at risk" -- on the earlier to occur of (1) a favorable outcome in patent litigation, (2) 30 elapsed months from the filing of a patent lawsuit, coupled to FDA approval of an abbreviated new drug application, or (3) the formal expiration of the relevant as-granted patents.

A technical note, here -- only the Temodar matter has resulted in a trial, thus far -- the trial concluded on April 2, 2009. Thus, there has been no decision rendered, as to factor (1), above, on any of these, so I'll omit it from the table below, for now. [And in the "credit where credit is due" department: J&J does a terrific job of setting all of this out (at page 25), in handy charts, for J&J investors -- so I've mocked one up, for Schering-Plough investors, below.]

Chemical NameBranded NameSales ($M/Yr)First Suit Filed30 Month Expiry/
First "At Risk" Date
Likely Competitor
DescloratadineClarinex®$800 MillionSeptember 2006May 2009*Orchid Pharma* (India)
EzetimibeZetia®$900 MillionMarch 2007October 2009Glenmark Pharma
TemozolomideTemodar®$950 MillionJuly 2007January 2010Barr Labs (Teva Pharma)
EptifibatideIntegrilin®$300 MillionFebruary 2009November 2011Teva Pharma

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* All but one potential generic Descloratadine manufacturer has agreed to a standstill until January 2012, for generic launches. I believe the one remaining is Orchid.

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I'll be off the grid for most of the day, today, so as you contemplate the above -- over your morning coffee, tea or chai -- discuss among yourselves whether there is any sound theory of executive compensation to justify payouts for 2006 of $16 million; for 2007 of $15 million, and now -- for 2008-2009 -- post May 1, 2009, perhaps an additional $100 million. Over the last three years, that is $131 million, to a CEO who generated a five-year "total shareholder return" of less than three quarters of one percent.
. . . .Do remember to add a little more than $7 million -- for every single dollar in stock price increases, from the base of $22.91 -- by merger time. . . .

2 comments:

Anonymous said...

Temodar's major market is for glioblastoma.

This can't be good for the sales of Temo:

http://www.fiercepharma.com/story/avastin-nabs-quick-glioblastoma-ok/2009-05-06

Condor said...

Thanks!

It's now a new post -- above.

Great find!

Namaste