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Corixa announces European approval for Fendrix®,
GlaxoSmithKline Biologicals' hepatitis B vaccine containing Corixa's MPL®
adjuvant
02/08/2005
SEATTLE, February 8, 2005 – Corixa Corporation (Nasdaq: CRXA), a developer of
immunotherapeutics, today announced that GlaxoSmithKline Biologicals (GSK
Bio) has received European approval for its hepatitis B vaccine, Fendrix®,
containing Corixa’s MPL® adjuvant.
Fendrix, GSK Bio’s novel vaccine containing Corixa’s MPL adjuvant, is
designed to prevent hepatitis B in patients with renal insufficiency,
including specific high-risk groups such as pre-haemodialysis and
haemodialysis patients from 15 years of age onwards. Haemodialysis patients’
immune response is typically lower than in healthy individuals, therefore a
need exists for a vaccine with an improved immunogenicity profile to ensure
that patients are protected against hepatitis B infections.
Fendrix builds on GSK Bio’s more than 15 years of experience with the
hepatitis B vaccine, Engerix B®, of which more than 1 billion doses have been
distributed worldwide.
"Today’s product approval marks another significant commercialization
milestone for our adjuvant business," said Steven Gillis, Ph.D., chairman and
chief executive officer of Corixa. "Given that our MPL adjuvant is a
component of several additional GSK vaccines now in late-stage clinical
trials, we look forward to the growth of our adjuvant business and its
potential contribution to Corixa’s future product sales and royalty income."
Adjuvants are formulated compounds or additives that, when combined with
vaccine antigens, help to either direct or boost the body’s immune system.
GSK Bio, one of the world’s leading vaccine developers, is developing a
portfolio of novel and proprietary adjuvant systems capable of either
directing the most appropriate immune response or increasing the immune
response in order to increase the effectiveness of a vaccine to prevent a
particular disease.
Corixa’s MPL adjuvant is a component in many of GSK’s proprietary and novel
adjuvant systems contained in multiple GSK Bio vaccines, including:
GSK Bio’s vaccine for human papilloma virus/cervical cancer that recently
showed 100 percent efficacy against persistent infection with HPV types 16
and 18 (Lancet 2004;364:1757 – 65);
GSK Bio’s malaria vaccine, which also recently reported breakthrough results
in clinical trials in the field (Lancet 2004;364:1411 – 20);
GSK Bio’s genital herpes vaccine, which demonstrated significant efficacy
against genital herpes in women in a phase III trial published in 2002
(Stanberry LR, Sprunance SL, Cunningham AL et al, N. Engl; Med 347(21),
1652-1661); and,
GSK Bio’s vaccine in Phase I clinical trials for the prevention of
tuberculosis.
About Corixa’s Adjuvant Business and MPL
Corixa’s adjuvant technology is based on the fact that certain microbial
products have long been recognized as potent immune system regulators and
have been shown to induce a broad range of known cytokines, a class of
substances that are produced by cells of the immune system and can affect the
immune response. Modifications of these microbial products and their physical
and biological delivery to the immune system can influence the way cytokines
are expressed, as well as the recipient’s own physiological responses. Such
responses mimic the normal, protective responses that are initiated during
microbial infection or injury. With its partners, Corixa is evaluating its
adjuvants in adult and pediatric vaccines that are designed to be safe and
more effective in protecting against a broad range of diseases.
Corixa’s flagship adjuvant, MPL, is a derivative of the lipid A molecule
found in gram-negative bacteria, one of the most potent regulators of immune
response. Corixa also owns patented technology for extracting MPL adjuvant
from bacterial cell walls. Several of Corixa’s partners are evaluating MPL
adjuvant for development of allergy, cancer and infectious disease vaccines.
MPL Manufacturing and Supply Agreement
Corixa entered into a new manufacturing and supply agreement with GSK in July
2004 covering the production of its MPL adjuvant. The agreement, which runs
through 2012, guarantees payment to Corixa for supplying GSK with increasing
annual quantities of MPL peaking in 2008 at the current maximum output of
Corixa’s Hamilton, Montana, MPL manufacturing facility (approximately 2
kilograms/year). Under the terms of the agreement, Corixa agreed to expand
cGMP compliant MPL production capacity in association with anticipated
approvals of GSK vaccines that contain MPL adjuvant. Other elements of the
agreement include increased base pricing and annual price increases for MPL,
and payment of royalties to Corixa by GSK on all GSK vaccines containing MPL
adjuvant until 10 years after market introduction of GSK’s human papilloma
virus vaccine.
About Hepatitis B
Hepatitis B is the most common serious liver infection in the world. It is
caused by the hepatitis B virus that attacks the liver. The virus is
transmitted through blood and infected bodily fluids. This can occur through
direct blood-to-blood contact, unprotected sex, use of unsterile needles, and
from an infected woman to her newborn during the delivery process. According
to the Hepatitis B Foundation, hepatitis B can be 100 times more infectious
than the AIDS virus. More information is available at www.hepb.org.
About Corixa
Corixa is a biopharmaceutical company developing vaccine adjuvants and
immunology based products that manage human diseases. Corixa’s products are
currently in multiple clinical development programs, including several that
have advanced to and through late stage clinical trials. The company partners
with numerous developers and marketers of pharmaceuticals, targeting products
that are Powered by Corixa™ technology with the goal of making its potential
products available to patients around the world. Corixa was founded in 1994
and is headquartered in Seattle, with additional operations in Hamilton,
Montana. For more information, please visit Corixa's Web site at
www.corixa.com.
Corixa Forward-Looking Statements
This press release contains forward-looking statements, including statements
regarding the commercial potential for MPL adjuvant, the contribution of
recent accomplishments to our long term success, and our plans, objectives,
intentions and expectations. Forward-looking statements are based on the
opinions and estimates of management at the time the statements are made.
They are subject to certain risks and uncertainties that could cause actual
results to differ materially from any future results, performance or
achievements expressed or implied by such statements. Factors that could
affect Corixa's actual results include, but are not limited to, the "Factors
Affecting Our Operating Results, Our Business and Our Stock Price," described
in our Quarterly Report on Form 10-Q for the quarter ended September 30,
2004, copies of which are available from our investor relations department.
Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release.
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