Pharmacia & Upjohn Rises on FDA Panel Nod for Cancer-Drug Claim
Bloomberg News
September 4, 1998, 9:26 a.m. ET
Pharmacia & Upjohn Rises on FDA Panel Nod for Cancer-Drug Claim
Stockholm, Sept. 4 (Bloomberg) -- Pharmacia & Upjohn Inc.
shares rose as much as 8 percent in Stockholm today after the
Swedish-American drugmaker yesterday received the backing of
U.S. government experts to make stronger claims about a drug,
and won regulators' approval for a new, implantable eye lens.
Shares in Pharmacia & Upjohn, which also makes the Rogaine
treatment for baldness, rose as much as 28 kronor, or 8 percent,
to 379 in Stockholm, and recently traded at 371.5 kronor.
An advisory panel yesterday recommended unanimously that
the U.S. Food and Drug Administration allow the company to say
its already approved Camptosar, a drug used for patients with
cancer of the rectum or colon, can actually stave off death in
patients with metastatic or spreading cancer and in patients who
have become resistant to their only other existing drug option.
''We're quite excited about it,'' said Langdon Miller,
Pharmacia & Upjohn's vice president of clinical development for
cancer drugs. ''This really represents the first time that a
drug for colorectal cancer has ever been approved based on
survival data.'' The FDA typically follows the advice of its
expert committees.
The drug is already cleared by the FDA under what is known
as an accelerated approval, designed to get promising drugs to
desperately ill patients after an abbreviated testing period.
Before Camptosar, patients with colorectal cancer had few
options, so the FDA cleared the drug based on data showing only
that it reduced tumor size, but left unanswered some questions
about the drug's long-term benefits.
A ''survival'' claim may increase the likelihood the
sickest of cancer patients -- and their doctors -- would opt to
use the drug and try yet another round of chemotherapy.
Camptosar is made and sold in the U.S. by Pharmacia &
Upjohn, the world's 18th biggest drugmaker, and by leading
French drugmaker Rhone-Poulenc SA in Europe.
Eye Implant Also Approved
Separately, Pharmacia also won FDA approval for a new
implantable eye lens coated with the blood-thinning drug
heparin. It's designed to keep the lens clear of obstructions
and cause less inflammation in the eye than other implants.
Yesterday, the company presented a study, first released in
May, showing its Camptosar drug helps patients with metastatic
colorectal cancer who relapse or don't improve when treated with
5FU, a widely used drug that is decades old.
The data offer hope to the large number of patients whose
colon or rectal cancer is detected late and whose disease has
spread. Camptosar was the first drug in 40 years, and only the
second drug ever cleared, to treat the prevalent cancer when it
won FDA approval in 1996. The agency backed the drug for use in
colorectal cancer once other treatments have failed.
Longer Survival
Data from a study of 279 patients with relapsed, metastatic
colorectal cancer showed the drug kept patients alive longer and
increased their ability to function normally for longer.
Patients taking the drug were 2.6 times as likely to
survive another year than were patients who received supportive
care such as pain medication but no aggressive therapy after the
first drug failed.
The study shows the drug improves the quality of life as
well as extending it. Patients on the drug regimen fared
significantly better in terms of overall performance, pain, and
weight loss, and almost all other measures of quality of life.
While the drug has been available for use in colorectal
cancer patients, this is proof for doctors that its benefits far
outweigh the cost of side effects such as diarrhea. In
terminally ill patients, that is the equation doctors must
weigh.
Pharmacia is already researching the use of the drug as a
first option for cancer patients and is looking at its
application to other cancers. The current market for the drug is
about 50,000 patients, Miller estimated.
Metastatic colorectal cancer, or cancer where the disease
has spread throughout the body, is more difficult to treat than
the early form of the disease. About 95 percent of patients
whose cancer is detected early survive at least five years,
according to the American Cancer Society. Camptosar could have
the potential to actually cure patients whose cancer is detected
early, Miller said.
Well over half of all patients with the disease have more
advanced forms, and the odds of survival plummet the more the
cancer has spread.
Only 38 percent of Americans age 50 or over have ever been
screened for the cancer, and only 29 percent have been screened
in the past five years, according to a report issued by the
Centers for Disease Control and Prevention.
No. 2 Cause of Cancer Deaths
Among cancers, only lung cancer kills more Americans than
colorectal cancer, which kills about 55,000 people a year in the
U.S. alone.
The FDA's approval of the company's CeeOn heparin-coated
eye lens offered more good news. The lens, already sold in
Europe, is implanted into the eye to replace natural lenses
damaged by cataracts.
The approval, expected after an FDA advisory panel
unanimously recommended the lens in October 1997, may help
Pharmacia & Upjohn grab a larger share of the $400 million-a-
year U.S. market for implantable lenses, which are also made by
a host of other companies including Allergan Inc. and Mentor
Corp.
Lens implants are most often used in the surgical treatment
of cataracts -- a condition in which the eye lens is gradually
clouded by changes in tiny protein fibers until vision is almost
destroyed. The condition generally occurs in the elderly and is
most often treated by removing the damaged surface of the eye
and replacing it with a synthetic lens implant.
Pharmacia's U.S. shares rose to 44 9/16 from 44 1/8
yesterday.
--David Bentow in the Stockholm newsroom (468) 610 0700 and |
