Merck Gives Glimpse
At Its
Drug Pipeline
By PETER
LOFTUS
December 12, 2006 11:35
a.m.
WHITEHOUSE STATION, N.J. -- Merck & Co. said
Tuesday it expects to file for regulatory approval in 2007 for proposed
new treatments for HIV, insomnia and heart disease.
The drug maker is currently awaiting Food and Drug
Administration action on pending applications for three other drugs,
including Arcoxia, an arthritis medication whose approval has been delayed
for several years. Merck disclosed Tuesday the FDA plans to hold an
advisory meeting for Arcoxia, but it hasn't yet been scheduled. The FDA
typically schedules advisory meetings when it wants advice from outside
experts about a drug's safety or effectiveness.
Merck also confirmed for the first time that it's
developing a cholesterol drug in the same class as torcetrapib, the
once-promising compound for which Pfizer Inc. halted development
earlier this month due to a higher-than-expected death rate in a patient
trial. The study's halt raised concerns that other so-called CETP
inhibitors in development would have safety problems.
But the Merck compound, MK-0859, showed no serious
cardiovascular problems in an eight-week mid-stage trial, Peter Kim,
president of Merck's research arm, told analysts and investors gathered at
the company's headquarters here. Also, it met the company's development
criteria of at least a 50% increase in good cholesterol levels and a 20%
decrease in bad cholesterol, Mr. Kim said. He said the drug's effect on
blood pressure was similar to a fake pill, or placebo. An elevation in
blood pressure had been seen in early Pfizer trials of torcetrapib.
"MK-0859 was generally safe and well tolerated and we do
not have cardiovascular events in patients taking those drugs," Mr. Kim
said. Merck is evaluating the data for MK-0859 to finalize its future
plans for the compound.
Merck has launched five new products during 2006, including
three vaccines. It's counting on continued pipeline success to help
replenish sales lost to drug-patent expirations as well as to the 2004
withdrawal from the market of the painkiller Vioxx due to safety
concerns.
Merck said it expects to have four drugs in late-stage
studies by mid-2007. These include a proposed weight-loss medication and
treatments for migraine headaches and osteoporosis. In total, Merck said
it has five development programs in late-stage, or Phase III, development;
21 programs in Phase II; and 28 programs in Phase I. It's not unusual,
however, for Phase I programs to fail to progress to later-stage
trials.
"We've advanced strong products in our pipeline at every
stage in development," Merck Chief Executive Richard Clark said
Tuesday.
In 2007, Merck expects to file for FDA approval of MK-0518,
an HIV integrase inhibitor; Gaboxadol, an insomnia treatment developed
with H. Lundbeck A/S; and MK-0524A, a niacin-based compound
designed to raise good cholesterol while minimizing a skin-related side
effect of niacin. Merck said it plans to submit for regulatory approval in
2008 a combination of MK-0524A with simvastatin, an existing drug that
lowers bad cholesterol and that Merck sells under the brand Zocor.
In addition to Arcoxia, the other Merck compounds under FDA
review are Janumet for the treatment of Type 2 diabetes and Emend IV, an
intravenous therapy for nausea and vomiting associated with
chemotherapy.
Merck's experimental weight-loss medicine, MK-0364, would
compete with Sanofi-Aventis's Acomplia, which has received European
regulatory approval but is awaiting FDA approval. Mr. Kim said Merck's
compound was safe and generally well tolerated in early studies, but also
was associated with adverse psychiatric experiences. Psychiatric disorders
also have been linked to Acomplia.
Separately, Merck reiterated the financial forecast for
2007 and beyond that it provided last week. Also, the company said that as
of Nov. 30, 27,200 lawsuits had been filed against the company in Vioxx
litigation.
Write to Peter Loftus at peter.loftus@dowjones.com1
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