The preliminary test results issued Wednesday at 1:30 a.m. EDT
continued Genentech's recent winning streak of good research news
and provided a welcome respite from the stream of bad news for
Biogen Idec, ever since the company and its partner Elan (ELN:NYSE)
pulled their multiple sclerosis drug Tysabri from the market on Feb.
Given the uncertainty over Tysabri, analysts who follow Biogen
Idec had said the Rituxan test was the next key event in the
Cambridge, Mass.-based company's recovery effort. Rituxan is
approved for treating non-Hodgkin's lymphoma, a cancer of the lymph
system, which helps protect the body against disease and infection.
Shares of Biogen Idec rose 72 cents, or 2.1%, to $35.49 in early
trading Wednesday. Shares of Genentech added 49 cents, or 0.9%, to
"These results continue to support the potential of Rituxan as a
new therapeutic option for rheumatoid arthritis," said Dr. Burt
Adelman, executive vice president for development at Biogen Idec.
"We look forward to sharing the data in our discussions with the
The companies offered no timetable for submitting an application to
the Food and Drug Administration. "Further analyses of the data are
ongoing and will be submitted for presentation at an upcoming
medical meeting." They didn't provide details.
Genentech's comments were a bit more cautious. "These are the
first phase III Rituxan data to demonstrate clinical improvement in
this difficult-to-treat rheumatoid arthritis patient population,"
said Dr. Hal Barron, Genentech's senior vice president of
development and chief medical officer. "While we are encouraged that
the preliminary safety results are similar to previous studies, we
recognize the importance of monitoring long-term safety in
rheumatoid arthritis patients treated with Rituxan."
Phase III clinical trials represent the last stage of testing before
companies submit drug applications to health care regulators.
Rituxan was approved by the FDA in November 1997.
Genentech and Biogen Idec market the drug in the U.S. Genentech's
majority owner, the Swiss drug company Roche, markets the
drug under the brand name MabThera in the rest of the world except
"While we view these early data as provocative, longer-term data
with a fuller efficacy [and] safety/tolerability are required" for
assessing Rituxan's potential as a treatment for rheumatoid
arthritis, says Jennifer Chao, of Deutsche Bank, in a Wednesday
Chao says Rituxan has "an established safety track record" as a
cancer treatment. As she awaits future test results, Chao views
Rituxan for rheumatoid arthritis as an "upside to our financial
projections." Still, she is keeping a hold rating on Genentech and a
sell rating on Biogen Idec. (She doesn't own shares of either
company; her firm has a non-investment banking relationship with
Genentech, and it is a market maker in Biogen Idec's stock.)
The rheumatoid arthritis test results compared patients taking
Rituxan plus methotrexate, a cancer drug that is also used in
treating rheumatoid arthritis, with patients taking methotrexate
plus a placebo. All patients also received corticosteroids.
Among the 520 patients tested at medical centers in the U.S.,
Canada and Europe, Rituxan patients achieved statistically
significant improvement in symptoms vs. the placebo group after 24
weeks of treatment. Improvement was based on measurements of reduced
swelling and tenderness in joints plus other indicators.
Patients enrolled in these clinical trials were those who had first
responded inadequately to one or more previous treatments of
rheumatoid arthritis drugs known as anti-TNF drugs. These
medications include Remicade from Johnson & Johnson (JNJ:NYSE),
Humira from Abbott (ABT:NYSE) and Enbrel from Amgen (AMGN:Nasdaq)
and Wyeth (WYE:NYSE). The latest test results represent "a
significant development for Rituxan for the rheumatoid arthritis
market," says Sagient Research Systems, a San Diego firm that tracks
biotech companies and their research efforts.
The anti-TNF drugs "have dominated the rheumatoid arthritis
market since their introduction, due to their efficacy," the firm
says. "However, there is still a significant proportion of
rheumatoid arthritis patients who either cannot tolerate or do not
respond to anti-TNF antibodies. Thus, Rituxan demonstrating efficacy
in this ... population is a significant boost to the drug."
Rheumatoid arthritis is an autoimmune disease that causes
inflammation of joints and deterioration of cartilage, bones and
tendons. In addition to rheumatoid arthritis, the companies are
testing Rituxan as a treatment for other autoimmune diseases such as
lupus and multiple sclerosis.