Glaxo Cancer Vaccine Recommended; Merck Shot Backed for Boys
GlaxoSmithKline Plc won a U.S.
advisory panel’s backing to introduce Cervarix, the first
cervical cancer vaccine to compete with Merck & Co.’s Gardasil.
The panel separately recommended expanding Gardasil use to boys.
The shots were ruled safe and effective by a panel of
outside advisers to the Food and Drug Administration meeting
today in Gaithersburg, Maryland. Both protect against strains of
human papillomavirus, or HPV, a common sexually transmitted
virus that can cause serious infections. The FDA usually follows
its panels’ recommendations, though it isn’t required to do so.
While regulatory delays for Cervarix gave Merck a head
start on the U.S. market in 2006, Glaxo aims to capitalize on
slowing sales of Gardasil. The London-based drugmaker’s biggest
challenge will be winning over doctors and parents to Cervarix,
according to analysts. Gardasil is already recommended by U.S.
health officials for school-age girls and comes with added
protection against genital warts.
“Cervarix is approved in many markets outside of the U.S.
already” where it has “approximately 35 percent sales market
share,” said Tim Anderson, an analyst at Sanford C. Bernstein &
Co. in New York, in a note to clients last week. “In the U.S.,
the product will be roughly three years behind Gardasil’s
introduction, and our belief is that it will not capture as much
share in the U.S. as it has internationally.”
American depositary receipts of Glaxo, each representing
two ordinary shares, rose 20 cents to $39.22 at 4:04 p.m. in New
York trading, before the meeting ended. Merck, of Whitehouse
Station, New Jersey, gained 58 cents, or 1.9 percent, to $31.55.
Merck shares have increased 39 percent since it announced plans
on March 9 to buy Schering-Plough Corp.
HPV Prevalence
Twenty million Americans are infected with HPV, and most
will be able to fight off the infection naturally. This year, an
estimated 11,270 new cases of cervical cancer will be diagnosed
in the U.S. and 4,070 women will die of the disease, according
to the National Cancer Institute. About 1 percent of sexually
active American men will develop genital warts from HPV,
according to U.S. Centers for Disease Control and Prevention.
Gardasil and Cervarix, given in three doses during a six-
month period, trigger immune responses that help protect against
the two HPV strains responsible for most U.S. cervical cancer
cases. Gardasil also protects against two additional strains of
HPV that cause 90 percent of genital warts. The shot costs about
$400 and is approved for females ages 9 to 26.
The FDA is scheduled to make a decision by the end of this
month whether to approve Cervarix’s use in women ages 10 to 25.
The shot is cleared in 98 countries and had sales of 125 million
pounds ($232 million) last year, or about one-sixth as much as
Gardasil. The average estimate of three analysts surveyed by
Bloomberg calls for sales of 758 million pounds in 2012.
Cervarix Delay
Safety concerns, including a higher number of young women
who reported miscarriages after getting Cervarix, contributed to
the delay with Glaxo’s March 2007 application, according to an
FDA staff review released before today’s meeting. The difference
in miscarriages wasn’t statistically significant and most of the
FDA advisers said Glaxo’s plan to register patients and monitor
pregnancies would mitigate any potential risks.
Cervarix should “just be marketed with the usual caveat
that it shouldn’t be used during pregnancy,” said panel member
Kenneth Noller, a professor in the obstetrics and gynecology
department at Tufts University School of Medicine in Boston. “I
don’t see anything compelling with these data at all.”
Expanded use of Gardasil in boys would help Merck counter
competition from Cervarix in the girls’ market. The shot is
available in more than 100 countries, including at least 40
where it is cleared for males. The FDA should decide by the end
of October whether to approve Gardasil’s use in boys and young
men ages 9 to 26 to prevent genital warts.
Side Effects of Gardasil
U.S. officials have received 12,424 reports of side effects
with Gardasil, about 54 reports for every 100,000 vaccine doses
distributed, according to a recent study in the Journal of the
American Medical Association. Only one person on the 13-member
panel voted against the safety and effectiveness of either
Cervarix or Gardasil, citing lack of long-term proof that HPV
vaccines are safe.
“There are too many issues going on,” said Vicky Debold,
the panel’s consumer representative. “We need to figure this
out before we subject boys to risks that are not necessary at
this point. This is a very, very important issue in terms of
public confidence.”
Sales Decline
Questions about side effects and cost caused Gardasil sales
to drop 5 percent last year to $1.4 billion, or 5.9 percent of
Merck’s revenue. Sanofi-Aventis SA, based in Paris, helps market
the product in some European countries. Anderson, of Sanford
Bernstein, estimates expanded use in boys will boost sales to
$2.43 billion in 2015.
Merck had sought approval to sell Gardasil to prevent pre-
cancerous lesions in boys and young men, as well as genital
warts. The FDA told the company in May the proposal for
prevention of “external genital lesions” was too broad,
according to the FDA’s staff review.
This restriction may hurt Merck’s ability to prove the shot
is cost effective for boys, said Keyur Parekh, a UBS AG analyst
in New York, in a Sept. 4 note to clients.
The CDC’s Advisory Committee on Immunization Practices, a
15-member panel that sets national recommendations for vaccine
use, probably will review Cervarix and Gardasil for boys in late
October, Parekh said.
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