Investors already knew the trial was a success, from way back in May.
The details presented at the American Heart Association meeting by Isis and its marketing partner Genzyme (Nasdaq: GENZ) seem to be what killed the stock.
Previously, we knew that one patient had dropped out of the study
because of elevated liver enzymes, a sign of potential liver toxicity.
It turns out that four patients -- it was a small study, so that's 12%
of those receiving the drug -- had elevated liver enzymes.
These patients have a genetic disease that causes them to have
abnormally high cholesterol even after taking cocktails of cholesterol
drugs, including Pfizer's (NYSE: PFE) Lipitor, AstraZeneca's (NYSE: AZN) Crestor, Merck's (NYSE: MRK) Zetia, and Abbott Labs' (NYSE: ABT) Niaspan. High liver enzymes, especially if it doesn't actually cause liver disease, won't keep the drug off the market.
The problem is that Isis and Genzyme would like to expand the drug
into more patients, where the same level of side effects could be
problematic. (Consider that causing hair to fall out is an acceptable
side effect for a cancer treatment, but not for a heartburn drug.)
Data from a trial testing patients with a less severe form of the
disease will be available in the first quarter of next year, so
investors won't have to wait long to see how problematic the side
effect really is. Since most cholesterol drugs cause elevated liver
enzymes in some patients, it's possible that the less severe patients
taking fewer medications in addition to mipomersen won't have
liver-enzyme issues.
The other mipomersen news yesterday was that the company now plans
to file its marketing application in the U.S. and E.U. "by mid-2011"
instead of "the second half of 2010." While somewhat disappointing, a
six-month delay doesn't deserve a 17% drop in share price.
It looks to me as if investors are overreacting here. Fools looking for a cheaper entry point into Isis are getting their wish.© 2009 UCLICK L.L.C.
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