profitable and fast-growing category of pharmaceuticals.
potential for Bayer.
It was the most
the market and its 0.4 much higher dosages of
mg dose had an competitors’
appeared to have significant powerful statin available on effect comparable to that of
Since LDL-lowering effect
of statins, cerivastatin’s
most important criterion
hopeful that this would reinvigorate its in the United States (Angelmar, 2007).
While in general, statins have relatively few side effects, one of
the most serious is the potential to cause rhabdomyolysis.
Rhabdomyolysis muscle protein
is a breakdown of muscle myoglobin being released
fibers which results in the
myoglobin is toxic and can substantially damage the kidney. diagnosed by the observation of creatine kinase (CK) levels approximately ten times above upper normal levels and muscle rare cases, the renal failure caused by the myoglobin can be
When cerivastatin was developed, this seemed like an isolated
In clinical trials of
percent of consistent
patients experienced with rhabdomyolysis.
earlier statins, between 0 and .5 elevated CK levels and muscle pain In only a single previous clinical
a statin led to a some knowledge of
Moreover, even though
there was little sense that risk of statins (Chong, P.H., Seeger, J.D.,
rhabdomyolysis differed and Franklin C., 2001).
among A Bayer
This chapter only considers Bayer’s litigation strategy in the United States. Merck & Co had released Mevacor (lovastatin) in 1987, and Zocor 5
(simvastatin) in 1988. (pravastatin) in 1991.
Bristol-Myers Squibb introduced Pravachol Novartis had Lescol (fluvastatin) released in
Finally, Lipitor was released in February of 1997, just
Baycol after being (Angelmar, 2007).
before by Pfizer
6 The .4mg dose of Baycol had the same efficacy as 10mg Lipitor, 20mg Zocor, 40mg Mevacor and 80mg Lescol (Angelmar, 2007).