Salix Pharmaceuticals Brings Colorectal Screening Outreach to Consumers in Partnership with Walgreens and The Colon Cancer Alliance
Annual National Program Aims to Break Down Barriers That Can Contribute to Low Screening Rates
RALEIGH, NC, March 4, 2008 – As a result of measurable success last year, Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) is again partnering with Walgreens (NYSE, NASDAQ: WAG) and the Colon Cancer Alliance (CCA) to raise awareness and increase screenings for colorectal cancer during Colorectal
Cancer Awareness Month.
The organizations will launch a comprehensive patient education campaign during the months of March and April to address early detection and prevention
of colorectal cancer (CRC) in Walgreens locations across the country and online. This campaign includes printed brochures in English and Spanish, store posters and print, electronic, radio and T.V. advertisements in select markets.
At the same time, the Colon Cancer Alliance will staff a toll–free helpline available to answer questions from those looking for more information
on CRC and have program materials to distribute. Salix will use their sales force to communicate with the healthcare providers and organizations they
call upon to raise awareness about the campaign and address any questions.
Through an unrestricted educational grant provided by Salix, the program will also offer a continuing education component to the more than 20,000 Walgreens
pharmacists, allowing them to better serve consumers who have questions about screening and prevention of CRC, as well as disease management. Last year more than 6,000 Walgreens pharmacists and pharmacy technicians participated in the continuing education portion of the program, better equipping
them to counsel patients and families about screening and prevention.
While screening for colorectal cancer often leads to early detection and saves lives, national statistics suggest that fewer than 50 percent of those who
should get screened actually undergo the screening.
"This program provides consumers with a local, trusted source for information about a topic many of us would honestly rather put off – but it's one
that can save lives. By increasing awareness and educating consumers on how to talk with their health care providers about screening, this program
enables consumers to make more educated decisions concerning their health," said Carolyn Logan, President and CEO, Salix Pharmaceuticals. "Salix
is proud to repeat this program through its partnership with Walgreens and the Colon Cancer Alliance to bring the best of our respective networks together
to inform the public and save lives."
Walgreens drugstores serve 5 million customers each day in 49 states and Puerto Rico. In addition, all pharmacy staff received pocket–sized guidelines
for colonoscopy procedures endorsed by the major patient advocacy and professional organizations.
"Feedback from both our pharmacists – who are among the most accessible health care professionals – and our customers tells us this program
played a major role in educating the public last year," said Nimesh Jhaveri, Walgreens director of pharmacy services. "We know that the public counts
on our pharmacists for health care information, and we are proud to continue our efforts to enhance the ability of our pharmacists to make a real
difference in peoples' lives."
Two separate recent polls support the goals of this awareness campaign. One indicates that pharmacists are among the most trusted professionals in the
nation1 and the other notes that patients who hold discussions with health care professionals about cancer topics are more knowledgeable about their
condition and the extent and availability of treatment options than those who did not2.
"We are hopeful these efforts will encourage more people to get screened for colorectal cancer. Arming people with information is the best weapon in the
fight against this preventable disease," added Logan. "Salix is dedicated to consumer education as well as providing gastroenterologists with tools
to make the screening process a more tolerable experience for all patients."
Salix is a leading gastroenterology pharmaceutical company with a significant market share voice; Walgreens is the nation's largest drugstore chain in sales; and The Colon Cancer Alliance is the nation's largest non–profit colorectal cancer organization with nearly 100 chapters spread throughout
the U.S.
The Facts
Despite being treatable and preventable, colorectal cancer is the second–leading cause of death from cancer in the U.S. Every four minutes a person
is diagnosed with colorectal cancer, equaling 154,000 Americans annually. Every nine minutes someone dies from the disease, translating to 55,000
Americans each year. In 2003, the U.S. spent over $6.5 billion treating the disease.
Few Americans know how preventable colorectal cancer really is. "So many people are missing a life–saving opportunity because they aren't getting
screened. That's why we are working with Salix and Walgreens on a national and community level to change this," said Timothy Turnham, CEO, Colon Cancer Alliance.
Less than 50 percent of eligible Americans have undergone screening, and more than 45 percent of patients are diagnosed at a time when the cancer is incurable.
If detected early, survival rates are near 90 percent.
"We are pleased to be a part of a successful ongoing campaign that works to educate the public taking important steps to prevent colorectal cancer. Our
hotline received more than 2,000 calls during the first half of the program last year and we're hopeful it will generate more calls in 2008," added
Turnham.
For more information visit www.walgreens.com/crc or call the CCA's toll free helpline at 877–422–2030.
More About the Partners
The Colon Cancer Alliance (CCA) is the largest national nonprofit colorectal cancer organization and includes nearly 100 chapters nationwide.
The CCA is dedicated to ending the suffering caused by colorectal cancer through patient support, education, research and advocacy. The CCA website (www.ccalliance.org)
includes information about screening, treatment, clinical trials, quality of life, financial issues and much more. The CCA produces a variety
of awareness and educational campaigns and provides support services for patients and their loved ones through a national conference, community–based
seminars, a toll free helpline (1–877–422–2030), chat forum and Buddy Program, which provides both survivors and caregivers
with a chance to connect with someone who has gone through a similar experience. All of CCA's campaigns, programs and services can be accessed
through the helpline or website.
Walgreens is the nation's largest drugstore chain with fiscal 2007 sales of $53.8 billion. The company operates 6,237 stores in 49 states and Puerto Rico.
Walgreens is expanding its patient–first health care services beyond traditional pharmacy through Walgreens Health Services, its managed care
division, and Take Care Health Systems, a wholly owned subsidiary that manages 147 convenient care clinics at drugstores. Walgreens Health Services
assists pharmacy patients and prescription drug and medical plans through Walgreens Health Initiatives Inc. (a pharmacy benefit manager), Walgreens
Mail Service Inc., Walgreens Home Care Inc. and Walgreens Specialty Pharmacy LLC. More information about Walgreens is available at Walgreens.com
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal
diseases. Salix's strategy is to in–license late–stage or marketed proprietary therapeutic drugs, complete any required
development and regulatory submission of these products, and market them through the Company's gastroenterology specialty sales and marketing team.
Salix markets COLAZAL® (balsalazide disodium), XIFAXAN® (rifaximin), OSMOPREP™ (sodium phosphate monobasic monohydrate,
USP, and sodium phosphate dibasic anhydrous, USP), MOVIPREP®
(PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), VISICOL®
(sodium phosphate monobasic monohydrate, USP, sodium phosphate dibasic anhydrous, USP),
AZASAN® (azathioprine tablets, USP), PEPCID® (famotide), ANUSOL–HC® (hydrocortisone cream, 2.5%)
(hydrocortisone acetate suppository, 25 mg) and PROCTOCORT® (hydrocortisone cream, 1%) (hydrocortisone acetate suppository, 30 mg).
Further product information may be found at www.salix.com. Current
development projects include balsalazide tablet, metoclopramide–Zydis®, encapsulated mesalamine granules, vapreotide acetate,
and rifaximin for additional indications.
1 USA Today/Gallup poll, December 8-10, 2006
2 Harris Interactive Poll
http://www.ecri.org/Patient_Information/HTTrends_Internet_Use_Article.pdf
For full prescribing information on Salix products, please visit www.salix.com or
contact the Company at 919–862–1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com or contact the Company at 919–862–1000. Information on our web site is not incorporated
in our SEC filings.
back to news
APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.
APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules.
The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO
granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame,
equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in at least 3%
of adult patients taking 1.5 g/day of APRISO were headache (11% vs. 8% for placebo), diarrhea (8% vs. 7% for placebo), upper abdominal pain (5% vs 3% for placebo),
nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza-like illness (4% vs 4% for placebo) and sinusitis (3% vs 3% for placebo).
For complete Prescribing Information, please click here.
MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the
colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MOVIPREP should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MOVIPREP administration. MOVIPREP contains a maximum of 2.33 mg of phenylalanine per treatment.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
Important Safety Information about OSMOPREP
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior
to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some
cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with
increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using
medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers
[ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).
It is important to use the dose and dosing regimen as recommended (PM/AM split dose).
OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing
of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OSMOPREP is used in
patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation,
bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal
function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte
disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OSMOPREP.
OSMOPREP is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with
biopsy–proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OSMOPREP be advised to adequately hydrate before,
during, and after the use of OsmoPrep.
For complete Prescribing Information for OSMOPREP including BOXED WARNING, please click here.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.
The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).
For complete Prescribing Information, please click here.
Important Safety Information about METOZOLV ODT
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.
The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia.
There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT
(metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal
reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and
recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. Take on
an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma;
known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the
usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide,
occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment,
but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all,
since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated
with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability.
The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression.
For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised
when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate
cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing
fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
Full Prescribing Information for METOZOLV ODT, including BOXED WARNING.