Prometheus Announces Co-Pay Assistance Savings Program for LOTRONEX(R) (alosteron...

Wed Sep 9, 2009 7:00am EDT
 
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Prometheus Announces Co-Pay Assistance Savings Program for LOTRONEX(R)
(alosteron HCl) Tablets




SAN DIEGO, Sept. 9 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty
pharmaceutical and diagnostic company, announced today that it is providing a
co-pay assistance savings program for LOTRONEX(R) (alosteron HCl) patients.

The savings program is available through physicians enrolled in the
Prescribing Program for Lotronex(TM) and local pharmacies. Patients are
responsible for the first $50 of their LOTRONEX prescription co-pay, after
which they are eligible to receive a savings of up to $250. This new offering
complements Prometheus' two-week sample voucher program currently in place to
support new patients. Patients can contact Prometheus customer service at
888.423.5227 to request information and learn more about the program. Note
that certain restrictions apply.

"Prometheus is doing its part to ensure that LOTRONEX patients who may be
facing tough financial times have better access to their medication," said
Joseph Limber, President and Chief Executive Officer of Prometheus. "This
program is another step in our continuing effort to support women who suffer
from severe diarrhea-predominant irritable bowel syndrome (IBS)."

About LOTRONEX
LOTRONEX is indicated for use only for women with severe diarrhea-predominant
IBS who have chronic IBS symptoms (generally lasting 6 months or longer), had
anatomic or biochemical abnormalities of the gastrointestinal tract excluded,
and not responded adequately to conventional therapy. Diarrhea-predominant IBS
is severe if it includes diarrhea and one or more of the following: frequent
and severe abdominal pain/discomfort, frequent bowel urgency or fecal
incontinence, disability or restriction of daily activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions
associated with LOTRONEX, the indication is restricted to those patients for
whom the benefit-to-risk balance is most favorable. Clinical studies have not
been performed to adequately confirm the benefits of LOTRONEX in men. Safety
and effectiveness in pediatric patients have not been established. Use of
LOTRONEX is not recommended in the pediatric population, based upon the risk
of serious complications of constipation and ischemic colitis in adults.

LOTRONEX has a boxed warning regarding serious gastrointestinal adverse events
that 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.(1)

Contraindications to LOTRONEX include constipation, history of severe bowel or
hepatic disorders, lack of understanding of Patient-Physician Agreement and
concomitant use of fluvoxamine.

New ACG Recommendations Published for IBS
The American College of Gastroenterology (ACG) recently published a new
evidence-based systematic review of the management of IBS. After conducting a
comprehensive meta-analysis of IBS therapies, the ACG IBS Task Force concluded
that the benefit and risk balance for LOTRONEX is most favorable in women with
severe IBS and diarrhea who have not responded to conventional therapies
(Grade 1B).(2)

Only physicians who have enrolled in the Prometheus Prescribing Program for
Lotronex, based on their understanding of the benefits and risks, should
prescribe LOTRONEX. The Prescribing Program for Lotronex was implemented to
help reduce risks of serious gastrointestinal adverse events. Information
about the Prescribing Program for Lotronex is available by calling
888.423.5227 or visiting www.Lotronex.com. Please see the accompanying
complete prescribing information, including Boxed Warning, for LOTRONEX at
www.Lotronex.com/PDF/us_lotronex.pdf.

About IBS
According to the National Institute of Diabetes and Digestive and Kidney
Diseases, in 2007, almost 60 million, or 20%, of the U.S. population had
symptoms of IBS, making it one of the most common disorders diagnosed by
physicians. At least twice as many women as men are affected by IBS, of which
more than 35% have IBS-D.(3,4) IBS is characterized most commonly by cramping,
abdominal pain, bloating, constipation and diarrhea. Although it significantly
impairs health-related quality of life, many people suffer from IBS for years
before being properly diagnosed and treated.

About Prometheus
Prometheus Laboratories Inc. is a specialty pharmaceutical and diagnostic
company committed to developing and commercializing novel pharmaceutical and
diagnostic products to help physicians individualize patient care. Prometheus
is a leader in applying the principles of personalized medicine to the
diagnosis and treatment of gastrointestinal diseases and intends to apply
these principles to oncology. Its strategy includes the marketing and delivery
of pharmaceutical products complemented by proprietary, high-value diagnostic
testing services. By integrating pharmaceutical products and diagnostic
testing services, Prometheus believes it can address the full continuum of
care, thereby providing physicians with a comprehensive solution to treat
chronic diseases. Prometheus' corporate offices are located in San Diego.

(1) LOTRONEX HCl (package insert). San Diego, CA: Prometheus Laboratories
Inc.; 2008
(2) An evidence based systemic review on the management of irritable bowel
syndrome. Am J Gasteroenterol. 2009;14(suppl 1):S21.
(3) Drossman D, Morris CB, Hu Y et al. A Prospective Assessment of Bowel Habit
in Irritable Bowel Syndrome in Women: Defining an Alternator.
Gastroenterology. 2005;128:580-589.
(4) El-Serag H.B., Pilgrim P, Schoenfeld. Systematic Review: Natural History
of Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2004;19:861-870.


SOURCE  Prometheus Laboratories Inc.

Pete De Spain, Director, Investor Relations & Corporate Communications of
Prometheus Laboratories Inc., +1-858-587-4117, pdespain@prometheuslabs.com

 

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