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[News Release from Genentech, Inc.] GENENTECH AND XOMA ANNOUNCE RESULTS OF PHASE II STUDY OF RAPTIVA™ IN PSORIATIC ARTHRITIS PATIENTS SOUTH SAN FRANCISCO, CA and BERKELEY, CA – March 21, 2004 - Genentech,
Inc. (NYSE: DNA) and XOMA Ltd. (Nasdaq: XOMA) today announced preliminary
results of a randomized, placebo-controlled Phase II study with RAPTIVA(tm)
(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-cells play 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
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.
Seventeen 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 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 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. ### www.flakehq.com |