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Prometheus Licenses Colal-Pred® From Alizyme
San Diego, November 29, 2007 – Prometheus Laboratories Inc., a
specialty pharmaceutical company today announced that it has
entered into an exclusive license agreement to develop and
commercialize COLAL-PRED® for gastrointestinal diseases or other
applications in North America from Alizyme Therapeutics Limited,
a wholly owned subsidiary of Alizyme plc. COLAL-PRED has a
unique competitive profile based on Alizyme's proprietary COLAL®
drug delivery technology which is designed to release a drug, in
this case an anti-inflammatory steroid, in the colon to provide
efficacy but without the undesirable side effects usually
associated with the use of systemic steroids.
Under the terms of the agreement, Prometheus made an up-front
payment which may be followed by additional payments on the
successful achievement of future development milestones,
including U.S. Food and Drug Administration (FDA) approval of
the product. Prometheus will also sponsor substantially all of
the clinical development costs for COLAL-PRED in North America
and pay royalty rates which increase with higher annual net
sales levels of COLAL-PRED. Subject to the successful completion
of clinical trials, Prometheus anticipates that it will file a
new drug application (NDA) with the FDA in 2011.
“We are delighted to partner with Prometheus in North America
for the development and commercialization of COLAL-PRED,” said
Tim McCarthy, Alizyme's Chief Executive Officer. “As a leader in
the provision of therapeutics and complementary diagnostics to
gastrointestinal specialists throughout the United States, we
believe Prometheus is uniquely positioned to maximize the
commercial potential of COLAL-PRED. This partnership with
Prometheus marks an important step in the commercialization of
COLAL-PRED in North America in parallel with our own development
and commercialization plans in Europe and the rest of the
world.”
“We are excited to have entered into this partnership with
Alizyme,” said Joseph M. Limber, President and Chief Executive
Officer of Prometheus. “COLAL-PRED adds a therapeutically and
commercially attractive development stage product to our
portfolio of proprietary, marketed pharmaceutical products, thus
strengthening our gastrointestinal franchise for the future.
COLAL-PRED can provide a complementary therapeutic to our IBD
Serology 7 diagnostic test, which helps physicians diagnose
ulcerative colitis and Crohn's disease.”
Ulcerative colitis is an inflammatory bowel disease (IBD), the
general name for disease that causes inflammation in the small
intestine and colon. Ulcerative colitis can be difficult to
diagnose because its symptoms are similar to other intestinal
disorders and to another type of IBD called Crohn's disease.
Ulcerative colitis is marked by inflammation and ulceration of
the innermost lining of the colon. Crohn's disease differs
because it causes inflammation deeper within the intestinal wall
and can occur in other parts of the digestive system including
the small intestine, mouth, esophagus, and stomach. Currently,
it is estimated around 700,000 Americans suffer from ulcerative
colitis.
About Prometheus
Prometheus is a specialty pharmaceutical company committed to
developing new ways to help physicians individualize patient
care. Prometheus focuses on the treatment, diagnosis and
detection of gastrointestinal, autoimmune and inflammatory
diseases and disorders. Prometheus' strategy includes the
marketing and delivery of pharmaceutical products complemented
by its proprietary, high-value diagnostic testing services. By
integrating therapeutics and diagnostic services, Prometheus
addresses the continuum of patient care, thereby providing
physicians with a comprehensive solution to treat chronic
diseases. Prometheus' corporate offices are located in San
Diego, California. Additional information about Prometheus can
be found at
www.prometheuslabs.com.
About Alizyme plc
Alizyme is a specialty biopharmaceutical development company,
focused on the therapeutic areas of metabolic disorders,
gastrointestinal disorders and cancer supportive care. In
addition to COLAL-PRED, it is developing cetilistat for the
treatment and management of obesity and related diseases, such
as Type II diabetes, renzapride for the treatment of irritable
bowel syndrome (“IBS”), and ATL-104 for mucositis, a side effect
of cancer therapy.
COLAL-PRED is the combination of Alizyme's proprietary colonic
drug delivery system, COLAL, and prednisolone metasulfobenzoate
sodium (“PMSBS”), an approved steroid in Europe. COLAL-PRED has
a starch coating that is only broken down in the gut by bacteria
occurring in the colon. This leads to topical delivery of PMSBS
to the colon rather than systemic delivery with the objective of
providing efficacy, but without the side effects of steroids;
however, the efficacy and safety of COLAL-PRED must be shown in
well-controlled, prospective clinical trials and approved by the
FDA.
COLAL is a drug delivery technology which enables drugs to be
taken orally, but then be specifically released in the colon.
Achieving colonic release with conventional oral dosage forms
has proven difficult because of the variation between
individuals in transit times and conditions within the
gastrointestinal tract. COLAL overcomes this difficulty by
covering small pellets containing the drug with a coating of
ethylcellulose and a specific form of amylose (derived from
starch). This coating prevents drug release in the stomach and
small intestine. When the pellets reach the colon, the amylose
in the coating is broken down by bacterial enzymes and the drug
is released.
This press release contains certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements are subject to
various risks, and Prometheus cautions that any forward-looking
information is not a guarantee of future performance. Actual
results may differ materially from those set forth in this
release due to the risks and uncertainties inherent in
Prometheus' business, including risks related to COLAL-PRED and
the license agreement with Alizyme including, without
limitation, Prometheus' ability to develop the licensed
products, or complete any required clinical trials, Prometheus'
ability to obtain required regulatory approvals of the licensed
products, adverse side effects or inadequate therapeutic
efficacy of COLAL-PRED and any resulting product liability
claims, the potential market for the drug delivery technology,
and the potential for termination of the license agreement.
There can be no assurance that Prometheus can successfully
commercialize or penetrate the market for the licensed products.
Contact
Prometheus Laboratories Inc.
Beth Kriegel, Senior Director, Finance and Investor Relations
858/410-2516
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