The UC: NORMAL surveys were fielded online between February and March 2007. For the physician survey, doctors were recruited by fax from a complete list of US board-certified gastroenterologists. Gastroenterologists who spent less than half their time in direct patient care were excluded from the study.
At the time the surveys were fielded (prior to the availability of a once-daily mesalamine), patients reported they found it difficult to adhere to medication dosing schedules. Forty-six percent of patients (n=451) reported they had not taken all of their medication in the past week and 41 percent of gastroenterologists (n=300) believed their patients were not adhering to their medications. Interestingly, 83 percent of patients report they would be willing to change to a new medication if their physician advised that they do so, and 89 percent of patients report that they would be interested in trying a once-daily 5-ASA medication.
According to survey results, some gastroenterologists may underestimate the level of disruption UC can have on patient lives. For example, 42 percent of patients surveyed report symptoms of UC cause some disruption to their everyday activities, while physicians estimate that this is true for just 17 percent of patients.
These physicians and patients also differ in their beliefs on flare frequency. UC patients surveyed report experiencing an average of eight disease flares per year (self-defined: five flares for mild patients, eight flares for moderate patients, and 11 flares for severe patients). Additionally, the frequency of disease flares was underestimated by physicians: 58 percent of gastroenterologists estimate that patients with mild UC will experience only one flare-up per year; 40 percent of gastroenterologists estimate patients with moderate UC will experience two flare-ups per year and 30 percent of gastroenterologists estimate three flare-ups; while 22 percent of gastroenterologists estimate patients with severe UC will experience six or more flare-ups per year.
The authors conclude that many patients find it difficult to adhere to multi-dose medication schedules and have accepted frequent flares, symptoms, and disruptions as normal rather than re-examining their disease management strategies and helping to improve compliance. “Improved physician-patient communication and more convenient medication dosing regimens, such as once-daily formulations, could result in better disease control and we believe, improved quality of life for those who suffer from UC," says Dr. Rubin.
Ulcerative Colitis: Patients’ Perception Compared with Other Chronic Diseases
A second presentation of the surveys’ findings analyzed UC patients’ responses to quality of life questions as compared to the responses of patients with three other chronic diseases (rheumatoid arthritis [RA], asthma, and migraine) and found that UC takes a relatively high psychological toll. Patients were recruited through an actively managed panel of approximately 900,000 US adults that includes people from all US demographic and geographic groups.
More UC patients indicate that they think their disease is controlling their lives (53 percent; n=451) than RA patients (44 percent; n=309), asthma patients (19 percent; n=305) or migraine patients (37 percent; n=305) (p < 0.05). UC patients also report feelings of stress (82 percent), depression (62 percent), and embarrassment (70 percent) at higher rates than patients with any of the other chronic conditions surveyed (p < 0.05).
The majority (62 percent) of patients with UC feel that the disease makes it difficult to lead a normal life, which is significantly higher than the proportion of patients with asthma (33 percent) or migraine (59 percent) who feel this way (p < 0.05).
“We conclude that patients with UC experience a significantly higher psychological burden, and their symptoms are frequently more disruptive to their lives, than patients with the other diseases in the survey. As such, we as physicians should initiate communication with UC patients on quality of life issues in order to better understand the effects this disease is having on them and aggressively treat the disease and its concomitant psychological effects to lessen the burden,” said Dr. Rubin.
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About LIALDA
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® 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 excipients.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize LIALDA in the US, Canada, Europe – known as MEZAVANT™ – (excluding Italy) and the Pacific Rim. 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 1percent of patients during clinical trials and resulted in discontinuation of therapy with LIALDA.
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.
SHIRE PLC
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 website: www.shire.com.
For further information please contact:
Media Blythe Bertolo (GolinHarris) +1 312 729 4463
Matthew Cabrey (Shire) +1 484 595 8248
GIULIANI SpA
Giuliani SpA, founded in 1889, is a privately owned specialty pharmaceutical company strategically focused in gastroenterology and dermatology. It is currently marketing proprietary products for the treatment and management of ulcerative colitis, Crohn’s disease, food intolerances and dermatological disorders. Giuliani’s R&D pipeline includes new chemical entities and biotechnological products targeted to treat inflammatory and autoimmune diseases.
COSMO Pharmaceuticals SpA
Cosmo is a specialty pharmaceutical company that aims to become a global leader in optimized therapies for certain gastrointestinal diseases. The company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections. Cosmo's most advanced development product is LIALDA™/ MEZAVANT™ a treatment for ulcerative colitis that is licensed globally to Giuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX technology is at the core of the company's product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. For further information on Cosmo, please visit the Company's Web site: www.cosmopharmaceuticals.com.
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® (Human TGFâ3) and GA-GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE™ (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™ (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, 2006.
LIALDA™ is a trademark of Shire LLC.
PENTASA® is a registered trademark of Ferring A/S.
MMX® is a trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA. |
