Genentech and XOMA Announce Results Of Phase II Study of Raptiva(TM) in
Psoriatic Arthritis Patients
SOUTH SAN FRANCISCO, and BERKELEY, Calif., March 22 /PRNewswire-FirstCall/ --
Genentech, Inc. and XOMA Ltd. today announced preliminary results of a
randomized, placebo-controlled Phase II study with RAPTIVATM (efalizumab) in 107
patients with psoriatic arthritis. The study did not reach statistical
significance at 12 weeks (84 days) for the primary endpoint, ACR 20 response.
An ACR 20 response indicates at least a 20 percent improvement in an
individual's signs and symptoms of arthritis.
After 12 weeks of therapy, 28 percent of patients receiving RAPTIVA(TM) achieved
an ACR 20 response compared to 19 percent of patients receiving placebo. In the
subgroup of patients with moderate-to-severe plaque psoriasis, Psoriasis Area
and Severity Index (PASI) scores for patients receiving RAPTIVA were similar to
the statistically significant results demonstrated in Phase III clinical studies
in psoriasis. There was no worsening in the signs and symptoms of psoriatic
arthritis with RAPTIVA treatment. Treatment with RAPTIVA was well tolerated. There were no adverse events of arthritis on therapy or during the four-week
follow-up period after discontinuation of therapy.
"While the treatment effect of RAPTIVA did not show a significant benefit in
psoriatic arthritis, the effect on the skin manifestations of chronic
moderate-to-severe plaque psoriasis was consistent with data from our existing
clinical trial database. This observation demonstrates that while psoriatic
arthritis is associated with the skin disease psoriasis, these are distinct
diseases," said Hal Barron, M.D., F.A.C.C., Genentech's senior vice president of
Development and chief medical officer.
Genentech and XOMA plan to present these data at an upcoming medical meeting.
About Psoriatic Arthritis Psoriatic arthritis is an inflammatory disease that affects joints, ligaments,
tendons and, less frequently, the spine. Although psoriatic arthritis is
associated with and occurs in a subset of patients with psoriasis, they are
considered distinct diseases, which may have different pathophysiologies.
According to the American College of Rheumatology, nonsteroidal
anti-inflammatory drugs (NSAIDS) are the initial treatment for arthritis
symptoms in patients with psoriatic arthritis.
About RAPTIVA(TM) As a targeted T-cell modulator, RAPTIVA is designed to reversibly block the
activity of T-cells without destroying them. T-cellsplay a key role in the
development of psoriasis. In October 2003, RAPTIVA was approved by the U.S. Food and Drug Administration for the treatment of chronic moderate-to-severe
plaque psoriasis in adults age 18 or older who are candidates for systemic
therapy or phototherapy.
In clinical trials of RAPTIVA in patients with psoriasis, common adverse events
that occurred at least two percent more frequently in RAPTIVA patients than in
placebo included headache, infection (mostly upper respiratory infections),
chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and
acne. Five of these events (headache, chills, fever, nausea and myalgia) were
predominantly acute adverse events and were principally seen following the first
two injections of RAPTIVA. For the third and subsequent doses, the incidence of
acute adverse events was similar between the RAPTIVA and placebo groups. Less
than one percent of patients were discontinued from treatment due to acute
adverse events.
RAPTIVA(TM) is an immunosuppressive agent and has the potential to increase the
risk of infection and reactivate latent, chronic infections. Many
immunosuppressive agents have the potential to increase the risk of malignancy.
The role of RAPTIVA in the development of malignancies is not known. Serious
adverse events occurring in clinical studies with RAPTIVA, which were infrequent
and similar to placebo, include serious infections (0.4 percent in RAPTIVA vs. 0.1 percent in placebo), malignancy (the overall incidence of malignancies of
any kind was 1.8 per 100 patient-years for RAPTIVA-treated patients compared
with 1.6 per 100 patient-years for placebo-treated patients), thrombocytopenia
(0.3 percent), and worsening of psoriasis, typically upon discontinuation (0.7
percent).
RAPTIVA was developed in the U.S. through a partnership between Genentech and
XOMA for the treatment of moderate-to-severe plaque psoriasis. Genentech and
Serono have an agreement through which Serono receives an exclusive license to
market RAPTIVA outside of the U.S., Japan and certain other Asian countries. On
March 16, 2004, Serono announced approval for RAPTIVA in Switzerland for adult
patients with moderate-to-severe plaque psoriasis.
Serono announced in February 2003 that it had submitted a Marketing
Authorization Application (MAA) to the European Agency for the Evaluation of
Medicinal Products (EMEA) for European Union Approval of RAPTIVA in psoriasis. Serono anticipates a final decision during the second half of 2004.
About Genentech Genentech is a leading biotechnology company that discovers, develops,
manufactures and commercializes biotherapeutics for significant unmet medical
needs. Eighteen of the currently approved biotechnology products originated
from or are based on Genentech science. Genentech manufactures and
commercializes 13 biotechnology products in the United States. The company has
headquarters in South San Francisco, California and is traded on the New York
Stock Exchange under the symbol DNA. For additional information about the
company, please visit http://www.gene.com/.
About XOMA XOMA is a biopharmaceutical company focused on developing and manufacturing
antibody and other protein-based biopharmaceuticals for disease targets that
include cancer, immunological and inflammatory disorders, and infectious
diseases. XOMA's proprietary and collaborative product development programs
include: RAPTIVA(TM) for moderate to severe plaque psoriasis (marketed),
psoriatic arthritis (Phase II)and other indications in collaboration with
Genentech, Inc.; MLN 2222, a recombinant protein for reducing the incidence of
post-operative events in coronary artery bypass graft surgery patients with
Millennium Pharmaceuticals, Inc. (Phase I); a TPO mimetic antibody to treat
chemotherapy-induced thrombocytopenia in collaboration with Alexion
Pharmaceuticals, Inc. (preclinical) and a multiple antibody product candidate
program for the treatment of cancer in collaboration with Chiron Corporation
(preclinical). XOMA's proprietary bactericidal/permeability-increasing protein
(BPI)-derived programs include XMP.629, a topical formulation of a BPI-derived
compound for acne (Phase II), and NEUPREX(R) in a Phase I/II study to limit
complications following pediatric cardiopulmonary bypass surgery. For more
information about XOMA's product pipeline and antibody product development
capabilities and technologies, please visit XOMA's website at
http://www.xoma.com/.
Regarding XOMA: Statements contained herein related to product development and collaborative
arrangements, or that otherwise relate to future periods, are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These statements are based
on assumptions that may not prove accurate. Actual results could differ
materially from those anticipated due to certain risks inherent in the
biotechnology industry and for companies engaged in the development of new
products in a regulated market. These risks, including those related to safety
and efficacy of the products being studied; action, inaction or delay by the
U.S. Food and Drug Administration, European regulators or their advisory bodies;
analysis and interpretation of scientific data by these entities and others;
changes in the status of existing collaborative relationships; the ability of
collaborators and other partners to meet their obligations; and market demand
for products, are described in more detail in XOMA's most recent annual report
on Form 10-K and in other SEC filings.
Media Contact: Tara Cooper (650) 225-5505
Investor Contact: Lisa Tuomi (650) 225-6554
http://www.gene.com/ Media and Investor Contact: Laura Zobkiw
(510) 204-7273
DATASOURCE: Genentech, Inc.; XOMA Ltd.
CONTACT: Media, Tara Cooper, +1-650-225-5505, or Investor Contact: Lisa Tuomi, +1-650-225-6554, both of Genentech, Inc.; or Media and Investors, Laura Zobkiw of XOMA Ltd., +1-510-204-7273 Web site: http://www.gene.com/ http://www.xoma.com/
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