Warner-Lambert Cancer Drug Rejected by
FDA Panel (Update3)
Bloomberg News
September 1, 1998, 4:36 p.m. ET
Warner-Lambert Cancer Drug Rejected by FDA Panel (Update3)
(Adds further panel comment, closing share prices.)
Bethesda, Maryland, Sept. 1 (Bloomberg) -- Warner-Lambert
Co. failed to win the backing of a U.S. Food and Drug
Administration advisory panel for the company's Metaret prostate
cancer drug.
Panel members voted unanimously against recommending
approval of the drug, saying they couldn't be sure that its
benefits outweighed its risks.
Company studies ''leave us with real uncertainty about how
useful it is for the patient that walks in the door,'' said Derek
Raghavan, a panel member and associate director of the cancer
center at the University of Southern California.
The panel's vote came as a surprise after a major study
released in May -- and described to the panel today -- showed the
drug could slow the development of fatal prostate cancer and
reduce pain in patients who aren't helped by hormone treatments.
Shares of Morris Plains, New Jersey-based Warner-Lambert, one
of the world's top 20 drug companies, rose 6 3/8 to close at 71
5/8. The FDA typically follows the advice of its expert panels.
FDA officials said their analysis showed the drug's effects
were ''modest'' and that it helped the least sick patients the
most. They also voiced concerns about the drug's side effect
potential.
The drug poses ''a non-negligible risk for serious side
effects,'' said FDA reviewer Judy Chiao. She also said the
company had changed part of the study's design and planned
analyses after it was completed, which could have affected the
results.
Company Considering Next Step
Company officials said they were ''disappointed'' by the
panel's decision and need time to decide what their next steps
will be. ''It's going to take a while for us to gather our
thoughts,'' said William Slichenmyer, senior director of oncology
clinical research at Warner-Lambert's Parke-Davis unit. Still, he
said the company remains committed to the drug.
Earlier, company representatives told the panel Metaret
offered great promise for prostate cancer patients.
''It represents an exciting and innovative cancer
treatment,'' said Mario Eisenberger, a doctor from Johns Hopkins
Oncology Center who helped represent the company.
Several patients also testified before the panel saying the
drug had greatly helped them. In some cases, they said they
believed the drug had extended their lives by years.
Raghavan said he was frustrated because he had heard through
the ''grapevine'' from other doctors that the drug was extremely
effective in some patients. He said, however, that he had no data
to show that and couldn't vote in favor of the drug without it.
Before the meeting, analysts said Metaret could have sales
of about $150 million a year, adding to portfolio of drugs that
includes the top-selling cholesterol-lowering drug Lipitor and
the diabetes drug Rezulin. The company also makes consumer
products such as Schick razors and Trident gum.
The company presented a major study of nearly 460 patients
which compared Metaret in combination with hydrocortisone, a
generic steroid drug, to hydrocortisone alone. Using several
analyses, the company found that patients given Metaret, also
known as suramin, suffered significantly less pain and needed
less narcotics.
Pain Reduction 'Modest'
FDA's Chiao, however, said that the FDA's analyses of the
drug showed it offered a ''modest decrease'' in pain. She also
said that Immunex Corp.'s drug mitoxantrone, approved by the FDA
for a similar use, had more significant results.
Shares of Seattle-based Immunex rose 5 3/8 to 56.
Metaret's major side effects were swelling in the body,
weakness and anemia, the company said. Overall, 11 percent of
patients in the Metaret-plus-hydrocortisone group left the study
because of side effects compared to 3 percent in the
hydrocortisone-alone group, company officials said.
Warner-Lambert filed for FDA approval of the drug late last
year. First used as a parasite-fighting agent in Europe in the
1920s, the drug's benefits in cancer treatment were discovered by
researchers at the National Cancer Institute in the 1980s.
Prostate cancer is expected to strike nearly 185,000 men in
the U.S. this year, killing nearly 40,000. The cancer often
spreads beyond the prostate and can cause debilitating bone pain
as well as other problems.
Not Major Company Product
Although the prostate cancer market is large, Metaret wasn't
expected to be a major product for Warner-Lambert, analysts said.
Investors and analysts said they will look more carefully at how
quickly prescriptions grow for the company's leading Lipitor and
Rezulin drugs.
''Those are the two drugs people are watching,'' said Erick
Lucera, an analyst with Independence Investment Associates, which
holds about 590,000 shares of Warner-Lambert, according to
regulatory filings.
Warner-Lambert has risen about 34 percent in the past year
as Lipitor sales passed $1 billion in sales in less than one full
year on the market. The drug, one of about 25 with $1 billion or
more in annual sales, helped turn Warner-Lambert into an industry
superstar after years as an also-ran.
Rezulin, also introduced in 1997, could have 1998 sales of
$900 million, according to some estimates.
--Kristin Jensen in Bethesda, Maryland through the Washington |
