Immunex, Hoechst Drugs Open Front Against Rheumatoid Arthritis
Bloomberg News
November 13, 1998, 11:59 a.m. ET
Immunex, Hoechst Drugs Open Front Against Rheumatoid Arthritis
Renton, Washington, Nov. 13 (Bloomberg) -- Eighteen months
ago, Ron Sandelius, 61, had to get around by hobbling on the
sides of his feet because of painful swelling in his joints
caused by rheumatoid arthritis. He had taken two powerful drugs
for the disease to no avail.
Then Sandelius, a courier from the Seattle suburb of Renton,
enrolled in the clinical trials for Enbrel, a bioengineered drug
developed by Immunex Corp. Not only was he able to walk normally
again, last month he flew to Hawaii for an Iron Man competition.
He swam 2.4 miles, bicycled 112 miles, then ran a 26.2 mile
marathon, placing 11th among 31 athletes in his age group.
''I can't believe how great I feel,'' he said. ''Sometimes I
don't even feel like I have arthritis.''
Enbrel is part of a wave of new drugs that are changing the
lives of rheumatoid arthritis sufferers -- and may improve the
bottom lines of the companies that make the pharmaceuticals. The
drugs are the first new therapies to be approved for rheumatoid
arthritis by the U.S. Food and Drug Administration in 13 years.
The new drugs have the potential to generate billions of
dollars in sales for pharmaceutical companies, analysts say.
Enbrel alone may produce sales of between $300 million to $1
billion a year for Seattle-based Immunex, which is majority-owned
by American Home Products Corp. All told, existing arthritis
remedies and new ones constitute a market of as much as $10
billion a year, estimates David Molowa, an analyst with Bear
Stearns & Co.
Other Treatments
Besides Enbrel, which received FDA approval last week, the
new drugs include Malvern, Pennsylvania-based Centocor Inc.'s
Remicade, now awaiting FDA clearance, and another, Arava by
Hoechst AG of Frankfurt. Arava became the first new treatment for
the disease in more than a decade when it was approved in
September.
As many as five other treatments, by Centocor, Merck & Co.,
Monsanto Co. and Cypress Bioscience Inc., may also gain FDA
approval within the next year.
While the new treatments don't appear to be a cure, they
represent the payoff of several decades of research. ''This is as
about as exciting a time we've ever had in rheumatology,'' said
Michael Weinblatt, a physician with Brigham & Womens Hospital in
Boston who has been treating rheumatoid arthritis patients for
some 20 years.
Progress Slow
Progress has been slow in developing weapons against the
disease partly because rheumatoid arthritis remains a mystery.
Scientists don't know why the disease leads the body's immune
system to attack joints and connective tissues, destroying bone
and cartilage.
Rheumatoid arthritis, which is most common in women, can be
managed in its early stages with painkillers such as aspirin,
ibuprofen or other anti-inflammatory drugs. As the disease
worsens, however, these drugs lose effectiveness.
For patients with milder forms of the disease, better
painkillers are coming. Merck, based in Whitehouse Station, New
Jersey, is racing with St. Louis-based Monsanto and its marketing
partner Pfizer Inc. of New York to sell so-called Cox-2 drugs
that offer painkilling strength like an ibuprofen drug but are
chemically engineered so they don't upset the stomach or
sometimes cause fatal internal bleeding. Fewer side effects will
also allow higher doses.
Worst Cases
As the disease progresses, patients take combinations of
painkillers, chemotherapy drugs, injected gold solutions and
steroids. Some patients continue to deteriorate, though.
In the worst cases, patients are unable to wash their hair
or get out of bed. Many have joints and bones replaced and
tendons repositioned. About 40 percent are unable to hold a job
within six years of diagnosis.
These are the patients who are most likely to be helped by
Arava, Enbrel or Centocor's Remicade drug -- already on the
market for treating the severe bowel disorder Crohn's disease and
under review by the FDA for a new use as an arthritis treatment.
Karen Brunelli, a 56-year-old housewife in Greendale,
Wisconsin, has been battling rheumatoid arthritis for 30 years.
She has taken countless drugs and undergone surgery, including an
operation to replace the joints in one hand and another to remove
deteriorating bones in her feet. ''Some days I was so exhausted
it was almost impossible to get out of bed,'' she said. ''My
energy level was down to zippo, nothing.''
Since participating in the Enbrel trial, Brunelli gets out
of bed each morning, does her household chores and goes shopping
on her own. Enbrel ''has given me back my life,'' she said.
Data released at the American College of Rheumatology
conference in San Diego this week shows that Remicade is safe and
effective in reducing swelling and tenderness in the joints of
people with advanced stages of rheumatoid arthritis.
Patients may also benefit from Cypress Bioscience's Prosorba
device, which won the backing of a panel of expert advisers to
the FDA last week and is now awaiting agency approval. The San
Diego-based company's device filters all of a patient's blood
through a special protein which calms the immune system factors.
Enbrel and Remicade will probably be used first in patients
like Brunelli, who have already tried several other drugs that
failed to keep their arthritis under control.
Fewer 'Accidents'
One of the most important factors about the new drugs is
that they are more precise, which means they stimulate fewer of
the body's other molecular functions ''by accident'' and so cause
fewer side effects.
The best treatments available before the emergence of the
new generation of drugs can cause lymphoma, blood disease, and
kidney and liver damage. Other drugs can trigger mouth ulcers,
osteoporosis, blindness, and potentially deadly gastric bleeding.
''The average therapy had associated side effects so
frightening it made me question my judgment to consider taking
them,'' said Lisa Caswell, a Seattle patient who testified at an
FDA hearing prior on Enbrel.
While doctors are still studying Enbrel's long-term effects,
Sandelius, the Iron Man contestant, said he doubts the drug will
lose its punch.
''With other medications I could start to feel them wearing
off,'' he said. ''With Enbrel, it still feels like I'm improving
after 15 months.'' He said he plans to return to Hawaii next year
for another Iron Man competition.
--Kristin Reed in Washington (202) 624-1858 and Jim Finkle in San |
