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US advisers back Merck’s cervical cancer vaccine

May 18, 2006

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) – The first vaccine to
protect young women and girls from a sexually transmitted virus
that causes cervical cancer won unanimous support from U.S.
advisers on Thursday, making approval likely next month.

Women’s health advocates hailed the vaccine as a major
advance against a deadly disease, while industry analysts said
it could boost its struggling manufacturer, Merck & Co. Inc..
Annual sales could top $2 billion, some said.

Shares of Merck rose after the panel vote, closing up 2.3
percent to $35.13 on the New York Stock Exchange.

The vaccine, named Gardasil, targets common types of the
sexually transmitted human papilloma virus, or HPV, which
causes genital and skin warts and most cervical cancer.

About 300,000 women worldwide die from cervical cancer each
year, including almost 4,000 in the United States.

Members of the U.S. Food and Drug Administration advisory
panel said they were persuaded by Merck’s studies showing
Gardasil shots prevented early-stage cervical cancer and
precancerous lesions in women and girls ages 9 to 26.

The FDA usually approves products endorsed by its advisory
panels.

Several panelists cautioned, however, that the vaccine
worked only against four HPV types and that women should still
undergo regular screening for the disease.

“It’s not going to get rid of all cervical cancer. There
are other HPV types that cause cancer,” said Dr. Monica Farley,
the panel’s chairwoman.

A final FDA decision is expected by June 8, putting Merck
ahead of a potential rival vaccine by GlaxoSmithKline Plc.
Merck officials said Gardasil would be available within a month
of approval.

Gardasil, given in three doses over six months, targets
four HPV types believed to cause more than 70 percent of
cervical cancer cases and 90 percent of genital warts.

Protection has lasted five years in 500 females who have
been monitored for that long, Merck officials said. Studies
will continue to see if booster shots are needed.

Merck said Gardasil could reduce annual deaths from
cervical cancer to about 90,000 if it were used globally. The
company said it would have the greatest impact if given to
girls before they become sexually active.

HPV infection is common, hitting about half of sexually
active adults sometime during their life, although it usually
causes no symptoms.

Dr. Bobbie Gostout, speaking for the Society of Gynecologic
Oncologists, said the vaccine offered a rare chance to further
cut deaths in the cases when it does cause cancer.

“Not since the introduction of the (Pap) test over a half a
century ago has such an opportunity existed,” she told the
panel. Pap tests, which can catch precancerous and cancerous
cells early, cut U.S. cervical cancer deaths by 74 percent.

Deutsche Bank analyst Barbara Ryan predicted the vaccine
would post peak annual sales of up to $2 billion, revenues
Merck badly needs to revive earnings growth following the
recall of its arthritis drug Vioxx and generic competition
beginning next month for its Zocor cholesterol fighter.

Merck also is studying Gardasil in older women and in
males, who can transmit HPV to women or develop penile and
other cancers from it.

Merck and France’s Sanofi-Aventis would market Gardasil
through a joint venture in Europe if it won clearance there.
Merck licensed the vaccine technology from Australian company
CSL Ltd..

Glaxo has said it plans to apply this year for U.S.
approval of its HPV vaccine called Cervarix. Both Glaxo and
Merck have filed applications for approval of the vaccines in
Europe.

(Additional reporting by Ransdell Pierson in New York)


Source: reuters



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