'On the Road Again' Events Planned in Ten Major Cities
PHILADELPHIA, March 9 /PRNewswire/ -- Today Shire Pharmaceuticals launched "On the Road Again," an informative patient education program for people with ulcerative colitis (UC), a disease that affects nearly 700,000 individuals in the United States. The interactive events will feature four expert presenters and will provide an opportunity for people with UC to ask questions and network with others who have UC.
Experts at each event will include a dietician, a leading gastroenterologist, a social worker or health psychologist, and an online health information professional. Topics will include the role of diet in UC, treatment options for UC, lessening the emotional burden of UC, researching UC on the Internet and building an online UC community.
Shire developed the program, scheduled to travel to 10 major cities across the country, in response to the results of a series of Shire-sponsored surveys completed in 2007 titled "UC: NORMAL (New Observations on Remission Management and Lifestyle)." The objectives of the surveys were to understand how UC affects patients' lives as well as the differences in physicians' and patients' perceptions of UC. Results revealed a number of challenges, including communication gaps between patients and physicians, compliance challenges with medications, and a high level of life disruption on the lives of people with UC. Additional details and results of the survey can be found at http://www.ucnormal.com.
"For people with UC, education is very important because this is a disease that can be significantly impacted by actions a person does or doesn't take," said Ian McGowan, MD PhD, professor of medicine at the University of Pittsburgh School of Medicine. "This program is also exciting because it will address the psychological and emotional challenges faced by those who suffer from UC and give people a chance to connect with others with UC."
People living with UC, as well as those who know someone living with UC, are invited to attend the free events, which include a healthy meal. The 10 cities to be visited are Miami, Houston, Atlanta, Chicago, New York City, Minneapolis, Philadelphia, Pittsburgh, Los Angeles and Long Island.
"Nearly two-thirds of those surveyed reported that having UC makes it difficult to lead a normal life and many have simply accepted the daily disruptions caused by their disease," said Mike Yasick, senior vice president and gastrointestinal global business unit leader, Shire Pharmaceuticals. "The 'On the Road Again' program is intended to empower people with UC across the country and provide them with the knowledge and tools necessary to better manage their disease and regain control of their lives."
For more information on UC and on the "On the Road Again" program, including the city schedule, speaker bios, and registration information, please visit http://www.RoadtoUCLearning.com.
Shire Pharmaceuticals is a specialty biopharmaceutical company that markets once-daily LIALDA(TM) (mesalamine) for the induction of remission in patients with active, mild to moderate UC. Shire also markets PENTASA(R) (mesalamine) for the induction of remission and treatment of patients with mild to moderately active UC. Please see Important Safety Information included below.
UC is a type of inflammatory bowel disease that produces chronic inflammation and sores or ulcers along the inside of the large intestine. Symptoms may include severe abdominal pain and cramping, frequent and sometimes uncontrollable bloody diarrhea, fatigue and weight loss. This chronic autoimmune disease is typically first diagnosed in people between the ages of 15 to 30 and is estimated to affect nearly 700,000 Americans. According to the National Institutes of Health, about five percent of people with UC will develop colon cancer.
LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. The safety and efficacy of LIALDA have been established for up to eight weeks. LIALDA is the first new formulation in this class to be approved since 2000. LIALDA is the only ulcerative colitis treatment that utilizes MMX(R) Technology. LIALDA with MMX Technology combines a pH dependent gastro-resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis), with a tablet core containing mesalamine with hydrophilic and lipophilic components.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize LIALDA in the US, Canada, Pacific Rim and Europe (excluding Italy). LIALDA is known as MEZAVANT XL(TM) in the UK and Ireland, and MEZAVANT(R) elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
Important Safety Information for LIALDA
LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks have not been established.
LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. Caution should be exercised when treating patients with pyloric stenosis or those allergic to sulfasalazine. Mesalamine has been associated with an acute intolerance syndrome (3 percent of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. If acute intolerance syndrome is suspected, prompt withdrawal is required. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. Reports of renal impairment have been associated with mesalamine medications. In patients with renal impairment, caution should be exercised, and LIALDA should be used only if the benefits outweigh the risks. No information is available for patients with hepatic impairment.
LIALDA is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (n=535), the most common treatment-related adverse events with LIALDA 2.4g/day, 4.8g/day and placebo were headache (5.6 percent, 3.4 percent and 0.6 percent, respectively) and flatulence (4 percent, 2.8 percent and 2.8 percent, respectively). Pancreatitis occurred in less than 1 percent of patients during clinical trials and resulted in discontinuation of therapy with LIALDA.
For more information about LIALDA and for Full Prescribing Information, please visit http://www.LIALDA.com.
Important Safety Information for PENTASA
PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
PENTASA is generally well tolerated. In worldwide clinical trials (n>2100), the most common adverse events were diarrhea (3.4 percent), headache (2.0 percent), nausea (1.8 percent), abdominal pain (1.7 percent), dyspepsia (1.6 percent), vomiting (1.5 percent), and rash (1.0 percent). As with other mesalamine products, serious adverse events may occur. PENTASA is contraindicated in patients with a hypersensitivity to salicylates. Caution should be used in patients with impaired hepatic or renal function. Patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria should be monitored during PENTASA therapy.
For more information about PENTASA and for Full Prescribing Information, please visit http://www.PENTASAus.com.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger, and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's Web site:
For further information please contact:
Media Blythe Bertolo (GolinHarris) +1 312 729 4463
Matthew Cabrey (Shire) +1 484 595 8248
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subject to change at any time. In
the event such risks or uncertainties materialize, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development including, but not limited to
the successful development of JUVISTA(R) (Human TGFB3) and veleglucerase
alfa (GA-GCB); manufacturing and commercialization including, but not
limited to, the establishment in the market of VYVANSE(TM)
(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder
("ADHD")); the impact of competitive products, including, but not limited
to, the impact of those on Shire's ADHD franchise; patents, including but
not limited to, legal challenges relating to Shire's ADHD franchise;
government regulation and approval, including but not limited to the
expected product approval date of INTUNIV(TM) (guanfacine extended release)
(ADHD); Shire's ability to secure new products for commercialization and/or
development; and other risks and uncertainties detailed from time to time
in Shire plc's filings with the Securities and Exchange Commission,
particularly Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2007.
LIALDA(TM) is a trademark of Shire LLC.
PENTASA(R) is a registered trademark of Ferring A/S.
MMX(R) is a trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
|SOURCE Shire Pharmaceuticals|
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