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Prometheus Laboratories Inc. to Acquire GlaxoSmithKline (GSK)
Bowel Drug
SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Nov. 7 /PRNewswire/
-- Prometheus Laboratories Inc., a specialty pharmaceutical
company has signed an agreement with GlaxoSmithKline to acquire
exclusive rights to Lotronex(R) (alosetron hydrochloride)
Tablets in the United States. Lotronex is the only prescription
drug approved by the FDA for use in female patients with severe
diarrhea-predominant irritable bowel syndrome who meet the
conditions stated in the label. Prometheus will market and sell
Lotronex under an exclusive distribution agreement until the
acquisition is completed, which is expected in January 2008.
Prometheus will continue to offer Lotronex exclusively through
the currently established Prescribing Program for Lotronex(TM) (PPL).
Lotronex may be prescribed only by physicians who have enrolled
in the PPL.
"The acquisition of Lotronex is a significant opportunity for
Prometheus and an important next step in continuing to build our
portfolio of proprietary pharmaceutical products," said Joseph
M. Limber, President and Chief Executive Officer of Prometheus.
"Lotronex fits well with our long-term plans to grow through
acquisitions of meaningful therapeutic products and enhances
Prometheus' position as a leading provider of therapeutics and
diagnostics for physicians and their patients who suffer from
severe gastrointestinal diseases."
Commenting from GlaxoSmithKline, Stan Hull, Senior Vice
President, US Pharmaceuticals said, "We believe that Prometheus
is ideally positioned with their strong franchise and
relationships with gastroenterologists to market Lotronex and to
educate patients and physicians on its proper use."
Lotronex is indicated for use only in women with severe
diarrhea- predominant irritable bowel syndrome who have failed
to respond to conventional therapy, whose irritable bowel
syndrome, or IBS, symptoms are chronic, and who have had other
gastrointestinal medical conditions that could explain their
symptoms ruled out. Diarrhea-predominant IBS is severe if in
addition to diarrhea the patient experiences at least one of the
following symptoms: frequent and severe abdominal
pain/discomfort; frequent bowel urgency/fecal incontinence; or
disability/restriction of daily activities because of IBS.
Clinical studies have not been performed to adequately confirm
the benefits of Lotronex in men or patients under the age of 18.
Serious gastrointestinal adverse events have been reported with
the use of Lotronex. These events, including ischemic colitis
and serious complications of constipation, have resulted in
hospitalizations, blood transfusions, surgery and fatalities.
Lotronex should be discontinued immediately in patients who
develop constipation or symptoms of ischemic colitis. Lotronex
should not be resumed in patients who develop ischemic colitis.
Physicians should instruct patients who report constipation to
immediately contact them if the constipation does not resolve
after discontinuation of Lotronex. Patients with resolved
constipation should resume Lotronex only on the advice of their
treating physician.
About IBS
According to the American Gastroenterology Association, IBS is
one of the most common gastrointestinal disorders in the United
States affecting more than 58 million people. IBS affects all
races and both men and women; however, approximately 4 out of 5
(or 80 percent) of IBS sufferers are women. Although the cause
is currently unknown, IBS is characterized by multiple symptoms
that include chronic or recurrent abdominal pain and discomfort
together with irregular bowel function, such as diarrhea,
constipation or alternating diarrhea and constipation.
Approximately 30% of women with IBS have diarrhea-predominant
IBS.
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 GSK
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to
improving the quality of human life by enabling people to do
more, feel better and live longer. For more information, visit
GlaxoSmithKline at
www.gsk.com.
Prometheus Forward-Looking Statements
This press release contains certain "forward looking" statements
within the meaning of the Private Securities Litigation Reform
Act of 1995. To the extent that any statements made in the news
release contain information that is not historical, these
statements are essentially forward-looking and are subject to
risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors. Prometheus cautions that any forward-looking
information is not a guarantee of future performance. The
acquisition of Lotronex is subject to certain conditions of
closing, including the accuracy of specific representations and
warranties. Assuming the acquisition closes successfully, the
Company may not successfully maintain or grow the market for
Lotronex for a variety of reasons. For example, the Company is
aware of other products under development and in clinical
testing for the treatment of IBS. In addition, to market
Lotronex, the Company plans to expand its sales force and the
product must be successfully manufactured in compliance with
current good manufacturing practices. Under the acquisition
agreement, the Company will be required to transfer
manufacturing from GlaxoSmithKline to other suppliers over a two
to three year period. If unsuccessful, the Company may not have
product available to sell. The market for personnel is
competitive, and there is no assurance that the Company can
recruit new personnel on a timely basis. It is difficult to
predict the impact of competitive products and pricing. The
number of products available for acquisition is limited and the
market for such products is competitive and expensive. There can
be no assurance that the Company will successfully complete the
acquisition of Lotronex or acquire any other new products.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations
are described under 'Risk Factors' in the Operating and
Financial Review and Prospects in the company's Annual Report on
Form 20-F for 2006.
The Prescribing Program for Lotronex and full prescribing
information are available by calling 1-888-423-5227 or visiting
www.Lotronex.com.
Contact
Beth Kriegel, Senior Director, Finance and Investor Relations of
Prometheus Laboratories Inc.,
+1-858-410-2516;
GSK US Media: Mary Anne Rhyne,
+1-919-483-2839, or
Karen Collins,
+1-919-483-2839, or
GSK US Analyst|Investor: Frank Murdolo,
+1-215-751-7002, or
Tom Curry, +1-215-751-5419
Web site:
http://www.prometheuslabs.com/
http://www.Lotronex.com/
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