Merck to Continue Development of Cholesterol, Obesity Drugs
- From: Marilyn Mann <mannm@xxxxxxxxxxx>
- Date: Tue, 11 Dec 2007 11:35:39 -0800 (PST)
Merck to Continue Development
Of Cholesterol, Obesity Drugs
By PETER LOFTUS
December 11, 2007 11:37 a.m.
WHITEHOUSE STATION, N.J. -- In somewhat risky moves, Merck & Co. plans
to continue development of experimental drugs for cholesterol and
obesity that are similar to other companies' drugs that had safety
problems.
The drugs are among seven experimental compounds that Merck is
evaluating in late-stage patient studies, Merck said Tuesday at a
meeting with investors. Merck plans to submit two of these, including
the weight-loss pill, for regulatory approval in 2008.
Merck plans next year to begin late-stage patient studies of
anacetrapib, which is designed to raise good cholesterol levels as
well as lower bad cholesterol. Pharmaceutical companies view a drug
that significantly raises good cholesterol as the next frontier in
cholesterol drugs, and one that could be a big seller. Scientists
believe raising good cholesterol could further reduce risk of heart
problems beyond what can be accomplished by drugs known as statins,
which primarily lower bad cholesterol.
But Pfizer Inc.'s costly effort to develop a drug to raise good
cholesterol ended in failure a year ago after a study showed an
increased risk of death with Pfizer's compound, torcetrapib. That drug
also was associated with increasing blood pressure in patients. Both
torcetrapib and anacetrapib are known as CETP inhibitors.
Merck has said anacetrapib hasn't been associated with an increase in
blood pressure in mid-stage studies so far. It now plans to begin a
"sequenced Phase 3" program of studies next year for anacetrapib,
which would measure key safety effects such as changes in blood
pressure. These could clear the way for an "outcomes" study, which
typically measures a compound's effects on concrete cardiovascular
events such as heart attacks, in addition to effects on cholesterol.
The outcomes study could begin as early as 2009, Merck said.
Merck's study plan indicates that anacetrapib is still several years
away from reaching the market, assuming it clears what are expected to
be high regulatory hurdles.
"Anacetrapib had no effect on blood pressure," Peter Kim, Merck's
president of research, told investors. "These effects of torcetrapib
appear to be due to an off- target, CETP-independent mechanism."
Also, Merck is developing an anti-obesity drug called taranabant. The
company began a Phase 3 study in 2006, and said Tuesday it plans to
submit it for Food and Drug Administration approval in 2008.
Merck said early studies of taranabant have shown it can help people
lose weight. But studies also have linked it to an increase in
psychiatric side effects. That's significant because it's in the same
drug class as Sanofi-Aventis's rimonabant, which was rejected by an
FDA advisory committee earlier this year, citing psychiatric side
effects. Sanofi has withdrawn its FDA application; the drug is
available in Europe under the brand Acomplia. European regulators have
warned that people with depression shouldn't take Acomplia.
"We also observed a dose-dependent increase in psychiatric adverse
experiences, which we think are mechanism-based," Mr. Kim said.
Nevertheless, Merck has decided to continue development of taranabant,
citing animal studies that suggest it's different from rimonabant.
However, the late-stage study includes lower doses of taranabant than
those studied in a mid-stage patient trial.
Other late-stage Merck compounds include proposed treatments for
migraines, acute heart failure, cancer, osteoporosis and a hepatitis B
vaccine.
Merck said Tuesday it anticipates regulatory action on two pending
drug applications during 2008: an injectable version of its Emend anti-
nausea drug; and Cordaptive, which is designed to raise good
cholesterol by a different mechanism than anacetrapib.
Merck said it would make two additional FDA applications for new
drugs: one for taranabant and one for MK-0524B, which would combine
Cordaptive with simvastatin, a statin that primarily lowers bad
cholesterol.
Also, Merck said it would file this month for FDA approval to widen
the approved age range of women who can take the Gardasil cervical-
cancer vaccine, to up to 45 years old; it's currently approved for
girls and women ages 9 to 26 years old.
Merck plans to submit data to the FDA on Gardasil's effectiveness in
males during 2008. Merck believes giving Gardasil to males would help
prevent the spread of the virus that causes cervical cancer, and would
prevent genital warts in males that are caused by the virus strains
targeted by the vaccine.
"The only true way to eradicate a sexually transmitted infection like
this is through immunizing both males and females," said Margaret
McGlynn, president of Merck's vaccines and infectious disease
business.
The company backed its financial outlook for 2007 and 2008.
--Jenny Park contributed to this article.
Write to Peter Loftus at peter.loftus@xxxxxxxxxxxx
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